A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC) Previously Treated With PEG-Intron + Ribavirin

Hepatitis C, Chronic Clinical Trial

Official title:

An Open-label Study of the Safety and Tolerability of PEGASYS Plus Ribavirin in Patients With Chronic Hepatitis C Viral Infection Who Could Not Tolerate or Were Unresponsive to PEG-Intron Plus Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087568
• Other study ID #: ML16965
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2004
• Last updated: October 1, 2015
• Start date: December 2002
• Est. completion date: August 2006

Study information

• Verified date: October 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 evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2006
• Est. primary completion date: August 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

• unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment

• use of 2 forms of contraception during the study in both men and women

Exclusion Criteria:

• women who are pregnant or breast-feeding

• medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)

• patients with decompensated cirrhosis

• patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ribavirin
1000/1200mg po bid for 36 or 60 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)

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	Proportion of patients able to complete prescribed length of Pegasys plus ribavirin therapy\n		36 and 60 weeks	No
Secondary	Sum score of Beck Depression Inventory and Fatigue Severity Score, proportion of patients with each flu-like symptom, >=2 log drop or undetectable HCV-RNA, or normal ALT levels, adverse events, laboratory values\n		Throughout study	No