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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
COPEGUS 800 mg or 1000-1200 mg po for 24 weeks
PEGASYS 180 micrograms sc once weekly for 24 weeks
Haemek Hospital; Gastroenterology
Afula, Israel
Clalit City Ashdod MC; Liver Clinic
Ashdod, Israel
Batyamon; Liver Unit
Bat Yam, Israel
Soroka Medical Center; Gastroenterology
Beersheba, 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
...and 10 more locations
End of Treatment Response Rate at Week 72 in Genotype 1
End of treatment response rate at Week 72 was reported for genotype 1.
Time frame: Week 72
End of Treatment Response in Genotype 2 and 3
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Time frame: Week 48
Sustained Viral Response (SVR) Rates in CHC Genotype 1
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
Time frame: Week 96
SVR Rates in Genotype 2 and 3.
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
Time frame: Week 72
Percentage of Participants With Adverse Event (AE)
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.
Time frame: Week 96
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.