A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: peginterferon alfa-2a [Pegasys]Drug: ribavirin [Copegus]
- Registration Number
- NCT01429792
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1013
- Adult patients, >/= 18 years of age
- Serologic evidence of chronic hepatitis C, genotype 1, 2, 3 or 4 by anti-HCV antibody test
- Documented pre-treatment HCV RNA quantitative result
- Compensated liver disease (Child-Pugh Grade A)
- Patient receiving standard combination treatment of Pegasys (peginterferon alfa-2a and Copegus (ribavirin)
- Decompensated liver disease (Child-Pugh Class B or C cirrhosis)
- Co-infection with active hepatitis A and/or hepatitis B
- History or evidence of a medical condition associated with liver disease other than HCV
- Signs and symptoms of hepatocellular carcinoma
- History of poorly controlled thyroid disease, elevated TSH or any clinical manifestations of thyroid disease
- Therapy with antineoplastic treatment </= 6 months prior to study day
- Diabetes mellitus in subjects receiving an insulin therapy
- Evidence of severe retinopathy
- Pregnant or breast-feeding women, and male partners of women who are pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm peginterferon alfa-2a [Pegasys] - Single Arm ribavirin [Copegus] -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 Week 4 The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment.
Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 Week 24 The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study.
Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment Week 12 The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment
Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment Week 12 The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 Week 24 The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment
Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment Week 4 The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With pEVR to Study Treatment at Week 12 Week 12 The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12.
Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment Week 12 The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment.
Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24 Week 24 The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment.
Trial Locations
- Locations (26)
Holy Family Medical Center; Gastroenterology
🇮🇱Nazareth, Israel
Chaim Sheba Medical Center; Gastroenterology
🇮🇱Ramat Gan, Israel
Maccabi Health Services MC
🇮🇱Tel Aviv, Israel
Poria Hospital; Gastroenterology
🇮🇱Tiberias, Israel
Haemek Hospital; Gastroenterology
🇮🇱Afula, Israel
Meir Medical Center; Gastroenterology
🇮🇱Kfar Saba, Israel
Rabin Medical Center; Gastroenterology - Liver Unit
🇮🇱Petach Tikva, Israel
Hasharon Mc; Gastroenterology
🇮🇱Petach Tikva, Israel
Kaplan Medical Center; Gastroenterology Unit
🇮🇱Rehovot, Israel
Assaf Harofeh; Gastroenterology
🇮🇱Zerifin, Israel
Clalit City Ashdod MC; Liver Clinic
🇮🇱Ashdod, Israel
Barzilai MC; Gastroenterology
🇮🇱Ashkelon, Israel
Batyamon; Liver Unit
🇮🇱Bat Yam, Israel
Bnei-Zion Medical Center; Gastroenterology
🇮🇱Haifa, Israel
Rambam Medical Center; Gastroenterology - Liver Unit
🇮🇱Haifa, Israel
Naharyia / Western Galilee MC; Gastro Unit
🇮🇱Nahariya, Israel
Clalit Strauss MC
🇮🇱Jerusalem, Israel
Sourasky / Ichilov Hospital; Gastroenterology - Liver Unit
🇮🇱Tel Aviv, Israel
Soroka Medical Center; Liver Unit
🇮🇱Beer Sheva, Israel
Soroka Medical Center; Gastroenterology
🇮🇱Beer Sheva, Israel
Clalit Pinsker Rishon; Liver Clinic
🇮🇱Rishon Lezion, Israel
Carmel Hospital; Liver Unit
🇮🇱Haifa, Israel
Wolfson Hospital; Gastroenterology Unit
🇮🇱Holon, Israel
Hadassah Hospital; Liver Unit
🇮🇱Jerusalem, Israel
Rebecca Sieff; Gastroenterology
🇮🇱Safed, Israel
Clalit Zamenhoff
🇮🇱Tel Aviv, Israel