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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]; Drug: ribavirin [Copegus]

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077649

NV17318

Details and patient eligibility

About

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Enrollment: 188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients >=18 years of age;
• body weight >85kg (187lbs);
• CHC (genotype 1);
• liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
• use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion criteria

• women who are pregnant or breastfeeding;
• male partners of women who are pregnant;
• conditions associated with decompensated liver disease;
• other forms of liver disease, including liver cancer;
• human immunodeficiency virus infection;
• previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 4 patient groups

PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg

Active Comparator group

Description:

Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks

Treatment:

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg

Experimental group

Description:

Participants received 180 μg of PEG-IFN \[peginterferon\] alfa-2a in 1 mL solution administered \[subcutaneously\] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered \[orally \] po daily in split doses for 48 weeks

Treatment:

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg

Experimental group

Description:

Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks

Treatment:

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]

PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg

Experimental group

Description:

Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.

Treatment:

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]

Drug: ribavirin [Copegus]

Drug: ribavirin [Copegus]