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A Study of Extended Therapy of PEGASYS (Peginterferon Alfa-2a) in Combination With COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C and Slow Response

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: COPEGUS (Drug); peginterferon alfa-2a [Pegasys] (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche

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.

Clinical Details

Official title: An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of PegasysŪ (Peginterferon Alfa 2a ) in Combination With CopegusŪ (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy: end of treatment response rate (virological), sustained viral response

Secondary outcome: Safety and Tolerability: AEs, laboratory parameters

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Exclusion Criteria:

- Decompensated liver disease

- Signs or symptoms of hepatocellular carcinoma

- Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus

Locations and Contacts

Afula 18101, Israel

Ashdod 77444, Israel

Bat Yam, Israel

Beer Sheva 84105, Israel

Haifa 31096, Israel

Haifa 33394, Israel

Haifa 34362, Israel

Holon 58100, Israel

Jerusalem 91120, Israel

Jerusalem 95146, Israel

Kfar Saba 44281, Israel

Nahariya 22100, Israel

Nazareth, Israel

Petach Tikva 49100, Israel

Rehovot 76100, Israel

Rishon Lezion 75299, Israel

Safed 13110, Israel

Tel Aviv 67891, Israel

Tiberias, Israel

Zerifin 70300, Israel

Additional Information

Starting date: December 2009
Last updated: August 17, 2015

Page last updated: August 23, 2015

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