An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver Cirrhosis
- Registration Number
- NCT01609049
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective observational study will evaluate the efficacy and safety of peginterferon alfa-2a in combination with ribavirin in participants with chronic hepatitis C, including participants with compensated liver cirrhosis, in clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1496
- Serologically confirmed chronic hepatitis C (CHC), hepatitis C virus (HCV) RNA detectable
- Compensated liver cirrhosis (Child-Pugh Class A) included
- Initiating combined therapy with peginterferon alfa-2a and ribavirin
- Human immunodeficiency virus (HIV) co-infection
- Contraindications for combined therapy according to actual prescribing information
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Chronic Hepatitis C Ribavirin Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements. Participants with Chronic Hepatitis C Peginterferon alfa-2a Naive and previously treated participants who received peginterferon alfa-2a in combination with ribavirin as per local labeling requirements.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) (less than [<] 50 International Units per Milliliter [IU/mL]) 24 Weeks Post Therapy Completion Baseline up to 24 Weeks Post Therapy Completion (approximately 3.5 years)
- Secondary Outcome Measures
Name Time Method Percentage of Naive Participants With Sustained Virological Response (SVR)) and Negative HCV RNA (< 50 IU/mL) at Week 4 and 12 Week 4, 12 Percentage of Previously Treated Participants With SVR and Negative HCV RNA (< 50 IU/mL) at Week 12 Week 12 Percentage of Previously Treated Participants With SVR and Decrease in HCV RNA by Greater Than or Equal to (>/=) 2 Logarithm 10 From Baseline at Week 12 Baseline, Week 12 Percentage of Naive Participants With SVR and Decrease in HCV RNA by >/= 2 Logarithm 10 From Baseline at Week 12 Baseline, Week 12 Percentage of Previously Treated Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 Week 24 Percentage of Naive Participants With SVR, Decrease in HCV RNA by Negative HCV RNA (<50 IU/mL) at Week 24 Week 24 Percentage of Participants With SVR and Dose Reduction of Ribavirin or Peginterferon alfa-2a due to Adverse Event Baseline up to approximately 3.5 years Percentage of Participants With Adverse Events Baseline up to approximately 3.5 years
Trial Locations
- Locations (57)
Dongnam Inst.of Radiological & Medical Sciences
🇰🇷Busan, Korea, Republic of
Altay Region Aids Center
🇷🇺Barnaul, Russian Federation
Barnaul City Hospital #5; Therapy
🇷🇺Barnaul, Russian Federation
Chelyabinsk State Medical Academy; Infectious Diseases
🇷🇺Chelyabinsk, Russian Federation
Chita State Medical Academy
🇷🇺Chita, Russian Federation
Ekaterinburg Regional Hospital #1; Gastroenterology
🇷🇺Ekaterinburg, Russian Federation
Irkutsk Regional Consulting and Diagnostic Clinical Center; Regional Center of Reumatolodic Deasise
🇷🇺Irkutsk, Russian Federation
Kaluga regional AIDS center
🇷🇺Kaluga, Russian Federation
Kazan State Medical University
🇷🇺Kazan, Russian Federation
Kemerovo City Infectious Clinical Hospital; Infectious
🇷🇺Kemerovo, Russian Federation
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