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OpenTrials
Completed

NCT Number: NCT02557646

An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C

The purpose of this open-label, non-randomized, single-arm, multicentre observational study is to investigate the influence of the cumulative dose (total administered dose/ planned dose) of ribavirin on the sustained virologic response (SVR) in participants who have been receiving combination therapy with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus).

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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

Primary location

Ajka, Hungary

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with serologically confirmed chronic hepatitis C
  • Participants using and accepting a double method of contraception

Exclusion criteria

  • Participants not approved by the national treatment guideline or the Interferon Committee for combined pegylated interferon-ribavirin treatment
  • Contraindications in the summary of product characteristics of pegylated interferon alpha-2a and ribavirin
  • Participants previously treated with pegylated interferon and/or ribavirin
  • Hepatitis B and Human Immunodeficiency Virus co-infections

Treatment and study plan

peginterferon alfa-2a

Biological

Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P

Other names: Pegasys

Ribavirin

Drug

Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.

Other names: Copegus

Primary outcomes

  1. Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin

    Time frame: 24 weeks after EOT (maximum up to 96 Weeks)

    Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment [EOT] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100.

Secondary outcomes

  1. Percentage of Participants With Virologic Response

    Time frame: Week 4, 12, 24 and at EOT (maximum up to 72 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response.

  2. Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin

    Time frame: Up to EOT (maximum up to 72 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented.

  3. Percentage of Participants With SVR According to Starting Dose of Ribavirin

    Time frame: 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented.

  4. Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin

    Time frame: Up to EOT (maximum up to 72 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day [mg/kg/day]) dose group is presented.

  5. Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin

    Time frame: 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented.

  6. Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin

    Time frame: Up to EOT (maximum up to 72 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.

  7. Percentage of Participants With SVR According to Dose Reduction of Ribavirin

    Time frame: 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.

  8. Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism

    Time frame: Up to EOT (maximum up to 72 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented.

  9. Percentage of Participants With SVR According to IL-28B Polymorphism

    Time frame: 24 weeks after EOT (maximum up to 96 Weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented.

  10. Percentage of Participants With Viral Relapse or Breakthrough

    Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported.

  11. Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin

    Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (<60%, 60-69%, 70-79%, 80-89%, and >90%) is reported.

  12. Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin

    Time frame: Week 4, 12, 24, at EOT Visit, 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented.

  13. Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin

    Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and >20 mg/kg/day) is presented.

  14. Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin

    Time frame: Up to 24 weeks after EOT (maximum up to 96 weeks)

    Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 23, 2015
Registry last updated
Mar 28, 2016

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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