A Study of Induction Dosing With Peginterferon Alfa-2a (40KD) and Ribavirin in Participants With Chronic Hepatitis C (CHC) Genotype 1

Hepatitis C, Chronic Clinical Trial

Official title:

A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00192647
• Other study ID #: ML17908
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 1, 2016
• Start date: September 2004
• Est. completion date: December 2008

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the addition of a higher-dose induction treatment period with peginterferon alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with Pegasys and ribavirin, compared to standard-dose treatment without induction dosing, in treatment-naive participants with CHC, genotype 1. The anticipated time on study treatment is 48 weeks, and the target sample size is 500 or more individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 896
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Adults 18 to 75 years of age

• Diagnosis of chronic CHC, genotype 1

• Chronic liver disease consistent with CHC infection per Australian Section 100 criteria

• Compensated liver disease

• Naive to interferon-based therapy for CHC infection

Exclusion Criteria:

• Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug

• Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)

• Chronic liver disease other than CHC infection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy 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:
• Peginterferon alfa-2a
For induction, participants will receive 360 mcg SC once weekly for 12 weeks. The standard regimen will include 180 mcg SC once weekly for 36 or 48 weeks, depending upon treatment assignment.
• Ribavirin
Participants will receive 1000 or 1200 mg PO daily in divided doses, with the dose determined using body weight, for 48 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Australia,  Canada,  Mexico,  New Zealand,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with sustained virologic response		24 weeks following completion of the 48-week treatment period	No
Secondary	Percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA)		Weeks 4, 8, 12, 24, and 48	No
Secondary	Percentage of participants with at least a 2-log drop in HCV RNA or unquantifiable/undetectable HCV RNA		Weeks 4, 8, 12, and 24	No
Secondary	Incidence of adverse events		Up to approximately 12 months	No