Peak Study - A Study of Pegasys (Peginterferon Alfa-2a (40KD)) in Combination With Copegus (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC).

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peginterferon alfa-2b (PEG-Intron); Drug: Peginterferon alfa-2a [Pegasys]; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00087607

ML17756

Details and patient eligibility

About

This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients at least 18 years of age
• CHC infection, genotype 1
• use of 2 forms of contraception during study in both men and women

Exclusion criteria

• previous systemic therapy with anti-viral, anti-neoplastic, or immunomodulatory agents
• medical condition associated with chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)
• decompensated liver disease
• women who are pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 2 patient groups

Peginterferon Alfa-2a + Ribavirin

Experimental group

Description:

Participants received Peginterferon alfa-2a (40 kD) \[Pegasys\] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin \[Copegus\] 1000 or 1200 milligram (mg)/day), orally, \[according to body weight, lesser than or greater than/equal to (\< or \>/=) 75 kilogram (kg), respectively\] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.

Treatment:

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa-2a [Pegasys]

Peginterferon Alfa-2b + Ribavirin

Active Comparator group

Description:

Participants received Peginterferon alfa-2b (12 kD) \[PEG-Intron\] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin \[Rebetol\] 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (\< or \>/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.

Treatment:

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa-2b (PEG-Intron)