A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus Ribavirin in Hemophiliac Patients With Chronic Hepatitis C.

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: ribavirin; Drug: peginterferon alfa-2a [Pegasys]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00475072

ML16814

Details and patient eligibility

About

This study will evaluate the efficacy and safety of PEGASYS plus ribavirin in male patients with hemophilia A and chronic hepatitis C. All patients will receive PEGASYS 180 micrograms s.c. weekly plus ribavirin 1000-1200mg p.o. daily (depending on body weight) for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Enrollment: 14 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male patients, >=18 years of age;
• hemophilia A;
• chronic hepatitis C;
• compensated liver disease.

Exclusion criteria

• therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months before start of study drug;
• hepatitis A, hepatitis B or HIV infection;
• chronic liver disease other than chronic hepatitis C.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

1

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: ribavirin