A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response
- Conditions
- Hepatitis C, Chronic
- Interventions
- Drug: COPEGUSDrug: peginterferon alfa-2a [Pegasys]
- Registration Number
- NCT01033448
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Adult patients >/= 18 years of age
- Chronic hepatitis C, genotype 1, 2, 3
- Compensated liver disease
- Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
- Decompensated liver disease
- Signs or symptoms of hepatocellular carcinoma
- Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm COPEGUS - Single arm peginterferon alfa-2a [Pegasys] -
- Primary Outcome Measures
Name Time Method End of Treatment Response Rate at Week 72 in Genotype 1 Week 72 End of treatment response rate at Week 72 was reported for genotype 1.
End of Treatment Response in Genotype 2 and 3 Week 48 End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Sustained Viral Response (SVR) Rates in CHC Genotype 1 Week 96 Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
SVR Rates in Genotype 2 and 3. Week 72 Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Adverse Event (AE) Week 96 An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Trial Locations
- Locations (20)
Holy Family Medical Center; Gastroenterology
🇮🇱Nazareth, Israel
Haemek Hospital; Gastroenterology
🇮🇱Afula, Israel
Clalit City Ashdod MC; Liver Clinic
🇮🇱Ashdod, Israel
Batyamon; Liver Unit
🇮🇱Bat Yam, Israel
Soroka Medical Center; Gastroenterology
🇮🇱Beer Sheva, Israel
Rambam Medical Center; Gastroenterology - Liver Unit
🇮🇱Haifa, Israel
Bnei-Zion Medical Center; Gastroenterology
🇮🇱Haifa, Israel
Carmel Hospital; Liver Unit
🇮🇱Haifa, Israel
Wolfson Hospital; Gastroenterology Unit
🇮🇱Holon, Israel
Hadassah Hospital; Liver Unit
🇮🇱Jerusalem, Israel
Clalit Strauss MC
🇮🇱Jerusalem, Israel
Meir Medical Center; Gastroenterology
🇮🇱Kfar Saba, Israel
Naharyia / Western Galilee MC; Gastro Unit
🇮🇱Nahariya, Israel
Rabin Medical Center; Gastroenterology - Liver Unit
🇮🇱Petach Tikva, Israel
Kaplan Medical Center; Gastroenterology Unit
🇮🇱Rehovot, Israel
Clalit Pinsker Rishon; Liver Clinic
🇮🇱Rishon Lezion, Israel
Rebecca Sieff Medical Center; Liver Unit
🇮🇱Safed, Israel
Maccabi Health Services MC
🇮🇱Tel Aviv, Israel
Poria Hospital; Gastroenterology
🇮🇱Tiberias, Israel
Assaf Harofeh; Gastroenterology
🇮🇱Zerifin, Israel