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Completed

NCT Number: NCT00724893

Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)

Treatment compliance is a key success factor in obtaining the full benefit of Pegetron (peginterferon alfa-2b [PegIFN-2b] plus ribavirin combination) therapy for patients. Treatment-naïve patients with chronic hepatitis C (CHC) in Canada to whom Pegetron Redipen was prescribed will receive Pegetron Redipen therapy in accordance with approved labeling. The study will assess the effect of the newly approved Pegetron Redipen on treatment compliance and its effect on sustained virologic response rates. Sustained virologic response is defined as negative hepatitis C virus ribonucleic acid (HCV-RNA) six months post-treatment.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment-naïve patients with chronic hepatitis C
  • Adults (>18 years of age)
  • Prescribed Pegetron Redipen
  • Must meet all requirements for treatment with Pegetron Redipen
  • Must be able to obtain reimbursement of medication through private or provincial coverage

Exclusion criteria

  • Active hepatitis B virus (HBV) infection (hepatitis B surface antigen [HBsAg] positive)
  • HIV antibody positive
  • Post liver transplant patients
  • Any other exclusion criteria as per the product Monograph

Treatment and study plan

PegIFN-2b

Biological

PegIFN-2b powder for solution adminstered subcutaneously using the newly approved Redipen. Dosing per approved labeling

Other names: Pegetron®, Pegylated interferon alfa-2b, PegIntron, SCH 054031

Ribavirin

Drug

Ribavirin capsules administered orally. Dosing in accordance with approved labelling.

Other names: SCH 018908

Primary outcomes

  1. Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1)

    Time frame: Up to 72 weeks

    This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid [HCV-RNA]) at either of the follow-up evaluation time points (12 weeks [window 10-14 weeks] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no".

  2. Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1)

    Time frame: Up to 62 weeks

    This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no".

  3. Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1)

    Time frame: Up to 72 weeks

    This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  4. Number of Participants Achieving SVR (Stage 2)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".

Secondary outcomes

  1. Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2)

    Time frame: Up to 48 weeks

    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment

  2. Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1)

    Time frame: Up to 72 weeks

    Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  3. Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)

    Time frame: Up to 62 weeks

    Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  4. Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  5. The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)

    Time frame: Up to 62 weeks

    Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  6. The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no".

  7. The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Chronic HCV Genotype (Stage 1)

    Time frame: Up to 62 weeks

    Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  8. The Number of Participants Achieving Viral Response at 12 Weeks After EOT by Liver Fibrosis Stage (Stage 1)

    Time frame: Up to 62 weeks

    Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  9. Number of Participants Achieving SVR by Liver Fibrosis Stage (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 = significant liver damage, the liver is fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  10. Number of Participants Achieving SVR by Chronic HCV Genotype (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks following EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  11. Number of Participants Achieving SVR by Viral Load (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL).

  12. Number of Participants Achieving SVR by Weight (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  13. Number of Participants Achieving SVR by Chronic HCV Genotype + Liver Fibrosis Stage (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas, and F4 = severe damage [cirrhosis] and liver no longer functions properly). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  14. Number of Participants Achieving SVR by Chronic HCV Genotype + Viral Load (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". Viral load categories were defined as High (≥100,000 Iu/mL) or Low (<100,000 Iu/mL). For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  15. Number of Participants Achieving SVR by Weight + Chronic HCV Genotype (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  16. Number of Participants Achieving EVR (Stage 1)

    Time frame: From Week 10 to Week 14

    EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  17. Number of Participants Achieving SVR by EVR Type (Stage 1)

    Time frame: Up to 72 weeks

    EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative after 12 weeks of treatment. SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  18. Number of Participants Achieving SVR by Gender (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  19. Number of Participants Achieving SVR by Race (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  20. Number of Participants Achieving SVR by Human Immunodeficiency Virus (HIV) Status (Stage 1)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no".

  21. Number of Participants With End of Treatment (EOT) Response (Stage 1)

    Time frame: Up to 48 weeks

    EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no".

  22. Number of Participants With EOT Response by Chronic HCV Genotype (Stage 1)

    Time frame: Up to 72 weeks

    EOT response was defined as HCV-RNA negative after 24 weeks of treatment in participants with HCV-RNA Genotype 2 or 3, and after 48 weeks of treatment in participants with Genotype 1, 4, 5, or 6. If there was no EOT information or if it was marked as "not done" then EOT was set to "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  23. Number of Participants With EVR by Selected Chronic HCV Genotypes (Stage 1)

    Time frame: Week 12

    EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at TW12. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  24. Relapse Rate by HCV Genotype (Stage 1)

    Time frame: Up to 48 weeks

    The relapse rate was calculated with these parameters: EOT "yes", EVR evaluation valid, and ≥22 weeks of follow-up data. There were no imputations for EOT or SVR. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  25. Number of Participants Discontinued From Study Drug Due to Adverse Events by Chronic HCV Genotype (Stage 1)

    Time frame: Up to 48 weeks

    An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment. For this analysis participants were grouped by their HCV genotype (Types 1-6); a genotype is a classification based on the differences in the genetic material within the hepatitis virus. Knowing the HCV genotype helps with deciding what type and what duration of treatment will be needed because each genotype demonstrates a different response to treatment in infected individuals.

  26. Number of Participants Achieving Rapid Virologic Response (RVR) (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

  27. Number of Participants Achieving EVR (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  28. Number of Participants Achieving RVR by Race (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

  29. Number of Participants Achieving EVR by Race (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  30. Number of Participants Achieving SVR by Race (Stage 2)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no".

  31. Number of Participants Achieving RVR Who Achieved SVR (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  32. Number of Participants Achieving EVR Who Achieved SVR (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  33. Number of Participants Achieving RVR by Liver Fibrosis Stage (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after four weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  34. Number of Participants Achieving EVR by Liver Fibrosis Stage (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  35. Number of Participants Achieving SVR by Liver Fibrosis Score (Stage 2)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". Liver fibrosis stage was measured with the METAVIR scoring system (F0=no fibrosis or liver damage, F1 = beginning of liver damage with some slight scarring, F2 = moderate liver damage, scarring advancing in liver and surrounding blood vessels, F3 =significant liver damage, the liver becomes fibrotic [scarred] and connects with other scarred areas , and F4 = severe damage [cirrhosis] and liver no longer functions properly).

  36. Number of Participants Achieving RVR by Weight (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".

  37. Number of Participants Achieving EVR by Weight (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  38. Number of Participants Achieving SVR by Weight (Stage 2)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  39. Number of Participants Achieving RVR by Chronic HCV Genotype 1 Subtype (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

  40. Number of Participants Achieving EVR by Chronic HCV Genotype 1 Subtype (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment.SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

  41. Number of Participants Achieving SVR by Chronic HCV Genotype 1 Subtype (Stage 2)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no". For this analysis participants were grouped by their HCV genotype subcategory (1a or 1b); subcategories are the result of a change in the genetic material in the viruses within the genotype.

  42. Number of Participants Achieving RVR by Gender (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment. Participants with no viral response information were considered viral response "no".

  43. Number of Participants Achieving EVR by Gender (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  44. Number of Participants Achieving SVR by Gender (Stage 2)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

  45. Number of Participants Achieving RVR by HIV Status (Stage 2)

    Time frame: Week 4

    RVR was defined as undetectable HCV-RNA after 4 weeks of treatment (window of 2 to 6 weeks). Participants with no viral response information were considered viral response "no".

  46. Number of Participants Achieving EVR by HIV Status (Stage 2)

    Time frame: Week 12

    EVR was defined as either HCV-RNA undetectable with a ≥2 log reduction in HCV-RNA from baseline or HCV-RNA undetectable after 12 weeks of treatment. Participants with no viral response information were considered viral response "no".

  47. Number of Participants Achieving SVR by HIV Status (Stage 2)

    Time frame: Up to 72 weeks

    SVR was defined as HCV-RNA negative at six months following EOT. Participants with no viral response information were considered viral response "no".

  48. Percentage of Compliance for Participants Achieving SVR Based on Medication Adherence Questionnaire (MAQ) (Stage 2)

    Time frame: Up to 72 weeks

    Compliance was defined as participants taking ≥80% versus <80% of their doses; compliance ≥80% was derived from participants who answered "always" or "most of the time" to Questions 4 (How often do you stick to your medication schedule for your Ribavirin?) and 5 (How often do you stick to your medication schedule for your Redipen [peginterferon] injections?) of the 6-question compliance questionnaire. Percentages are based on the total number of participants within each compliance category. SVR was defined as HCV-RNA negative at 24 weeks after EOT. Participants with no viral response information were considered viral response "no".

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Pegetron® Redipen™ Prospective Optimal Weight-based Dosing Response Program

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jul 30, 2008
Registry last updated
Aug 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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