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

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Open-label Study to Compare the Effect of PEGASYS Plus Ribavirin and PEG-Intron Plus Ribavirin on Viral Load Reduction in Interferon-naïve Patients With Chronic Hepatitis C Viral Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087607
• Other study ID #: ML17756
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2004
• Last updated: December 1, 2015
• Start date: December 2003
• Est. completion date: May 2006

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 (eg, hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure)

• decompensated liver disease

• women who are pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Copegus
1000/1200mg/day po
• PEG-Intron
1.5 micrograms/kg sc weekly
• Rebetol
1000/1200mg/day po
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral load reduction from baseline.		Week 12	No
Secondary	Viral load reduction		Weeks 4 and 8	No
Secondary	Viral AUC and AAUCMB.		Weekly	No
Secondary	AEs, laboratory parameters.		Throughout study	No