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NCT Number: NCT01392742

An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of 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

Primary location

Mhat - Pleven; Clinic of Gastroenterology, Pleven, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Serologically confirmed chronic hepatitis C (all genotypes)
  • Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion criteria

  • Coinfection with HIV and/or hepatitis B
  • Contraindications according to the SPC for Pegasys/ribavirin

Treatment and study plan

Primary outcomes

  1. Percentage of Participants With Sustained Virological Response (SVR)

    Time frame: 24 weeks after End of treatment (EOT) (up to Week 96)

    SVR was defined as undetectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) 24 weeks after completion of the actual treatment period (a single last undetectable HCV RNA Polymerase Chain Reaction [PCR] measured greater than or equal to >=140 days post-treatment).

  2. Percentage of Participants With Relapse

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

    Relapse was define as аn undetectable HCV RNA during the treatment period, but without such during the follow-up.

  3. Percentage of Participants Who Were Non-Responders

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

    Non-responders were those participants who had not reached аn undetectable HCV RNA during the treatment period.

Secondary outcomes

  1. Percentage of Participants With Positive Predictive Value on SVR at Week 4

    Time frame: Week 4

    Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/(number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.

  2. Percentage of Participants With Positive Predictive Value on SVR at Week 12

    Time frame: Week 12

    Predictive value determined the relationship of the virological response at specified time to the total response. Positive predicted value= number of true positives/( number of true positives+ number of false positives). SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. Percentage of participants who showed positive predictive value in treatment naive and those who failed previous treatment with interferon were reported.

  3. Correlation of SVR With Rapid Virological Response (RVR)

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

    Correlation of SVR with RVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment.

  4. Correlation of SVR With Early Virological Response (EVR)

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

    Correlation of SVR with EVR was based on 3 symmetric measures; Kendall's tau-b, Kendall's tau-c and Gamma. SVR was defined as undetectable HCV RNA 24 weeks after end of treatment. EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.

  5. Predictive Power Values of Host-, Virus- and Treatment-related Factors and Virological Response

    Time frame: Week 4 and 12

    Predictive value determined the relationship of host factors to virological response. Host factors included; RVR (EVR for Week 12), gender, liver fibrosis, HCV genotype, height and treatment duration for Week 4 after EOT excluding HCV genotype at Week 12 EOT. RVR was defined as having undetectable HCV RNA 4 weeks after start of treatment and EVR was defined as having undetectable HCV RNA 12 weeks after start of treatment.

  6. Duration of Treatment in Participants With SVR by HCV Genotype

    Time frame: Up to Week 72

    SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

  7. Cumulative PEG-IFN Alfa-2a Dose in Participants With SVR by HCV Genotype

    Time frame: Up to Week 72

    SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

  8. Cumulative Ribavirin Dose in Participants With SVR by HCV Genotype

    Time frame: Up to Week 72

    SVR was defined as undetectable HCV RNA 24 weeks after end of treatment.

  9. Percentage of Participants With Virological Response

    Time frame: 4 weeks after EOT (up to Week 76)

    The Virological response at the end of treatment was defined as the percentage of participants with undetectable HCV RNA, HCV test (based on a single last undetectable HCV RNA PCR falling in the 4 weeks' time window at end of treatment), is basically the sum of participants with SVR and with relapse.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Prospective Observational Study on Predictors of Early On-treatment Response and Sustained Virological Response in HCV-infected Patients Receiving Peginterferon Alfa-2a Plus Ribavirin

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2011
Registry last updated
Apr 10, 2017

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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