Observational Study Evaluating the Quality of Pegylated Interferon Alfa-2a and Ribavirin Treatment for Chronic Hepatitis C in Cooperation With the BNG (Association of German Resident Gastroenterologists)
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT02106156
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis C (CHC). Quality of care will also be assessed. Approximately 12% of the interferon-treated CHC patient population in Germany is expected to be studied over a period of 5 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10228
- 18 years of age or over
- Clinically diagnosed CHC with detectable virus replication
- Women of childbearing potential should use adequate contraception. It is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. During this time pregnancy tests have to be performed monthly. Particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (Copegus®). Both should use adequate contraception.
- Any contraindications for peginterferon alfa-2a or ribavirin treatment
- Pregnant or breast-feeding
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Chronic Hepatitis C Pegylated interferon alfa-2a Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study. Chronic Hepatitis C Ribavirin Participants with chronic hepatitis C planned for treatment with peginterferon alfa-2a alone or in combination with ribavirin according to routine clinical practice will be observed in this study.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Early Virologic Response (EVR) At Week 12 EVR is defined as HCV-PCR assay result qualitatively negative and/or decline of viral load of ≥2 log levels and/or viral load ≤50 IU/ml at Week 12.
Percentage of Participants With End of Treatment (EOT) Response Up to Week 72 EOT Response is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at the end of treatment.
Percentage of Participants With Sustained Virologic Response (SVR) Up to Week 96 SVR is defined as HCV-PCR assay result below limit of detection or viral load ≤50 IU/ml and/or qualitatively negative at least 12 weeks after the end of treatment at follow up. Follow-up visit occurred at 12 to 24 weeks following discontinuation of treatment.
Percentage of Participants With Rapid Virologic Response (RVR) At Week 4 RVR is defined as Hepatitis C-Virus (HCV) Polymerase Chain Reaction (PCR) assay result qualitatively negative and/or viral load ≤50 International Units/milliliter (IU/ml) at Week 4.
Percentage of Participants With Serious Adverse Drug Reactions (SADR) Up to Week 96
- Secondary Outcome Measures
Name Time Method Percentage Cumulative Dose of Peginterferon Alfa-2a Received Up to Week 96 Data for the accumulation of the cumulative dose of peginterferon alfa-2a were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.
Percentage Cumulative Dose of Ribavirin Received Up to Week 96 Data for the accumulation of the cumulative dose of ribavirin were analyzed and reported as the percentage of the intended dose participants received. Cumulative doses were evaluated for participants for whom dosage data were documented consistently throughout the observational period. If the treatment was ongoing at the study end, the cumulative dose was aggregated for the documented observational period.
Duration of Peginterferon Alfa-2a Therapy Up to Week 72 Treatment duration was evaluated for participants for whom dates of treatment start and end of therapy were documented.
Percentage of Participants With the Most Frequent Concomitant Medications At Baseline (Day 1) Most frequent concomitant medications were defined as those, which were observed in \>1 % of participants.