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

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Roche

Status and phase

Completed
Phase 4

Conditions

Hepatitis C, Chronic

Treatments

Drug: peginterferon alfa-2a [Pegasys]
Drug: COPEGUS

Study type

Interventional

Funder types

Industry

Identifiers

NCT01033448
ML21778

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

59 participants in 1 patient group

Single arm
Experimental group
Treatment:
Drug: COPEGUS
Drug: peginterferon alfa-2a [Pegasys]

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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