A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3

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

NCT01258101

ML17087

Details and patient eligibility

About

This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Enrollment: 395 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, 18-65 years of age
• Chronic hepatitis C, genotype 2 or 3
• Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
• Abdominal sonography within 3 months prior to study start

Exclusion criteria

• Previous interferon and/or pegylated interferon and ribavirin therapy
• Liver cirrhosis, class B or C (Child-Pugh)
• Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug
• History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
• Decompensated liver disease
• Positive for HIV

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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395 participants in 4 patient groups

Peginterferon/Ribavirin 800 mg (24 Weeks)

Experimental group

Description:

Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).

Treatment:

Drug: ribavirin

Drug: ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Peginterferon/Ribavirin 400 mg (24 Weeks)

Experimental group

Description:

Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.

Treatment:

Drug: ribavirin

Drug: ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Peginterferon/Ribavirin 800 mg (16 Weeks)

Experimental group

Description:

Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.

Treatment:

Drug: ribavirin

Drug: ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]

Peginterferon/Ribavirin 400 mg (16 Weeks)

Experimental group

Description:

Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.

Treatment:

Drug: ribavirin

Drug: ribavirin

Drug: peginterferon alfa-2a [Pegasys]

Drug: peginterferon alfa-2a [Pegasys]