Latino Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) in Treatment-Naive Patients With Chronic Hepatitis C-Genotype 1.

Hepatitis C, Chronic Clinical Trial

Official title:

An Open-label Study of PEGASYS Plus Ribavirin on Sustained Virological Response in Treatment-naïve Latino White Patients Compared With Non-Latino Caucasian Patients With Chronic Hepatitis C, Genotype 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00107653
• Other study ID #: ML18179
• Status: Completed
• Phase: Phase 4
• First received: April 6, 2005
• Last updated: December 1, 2015
• Start date: August 2004
• Est. completion date: February 2008

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 single arm study will evaluate the efficacy and safety of PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latino patients versus non-Latino Caucasian patients with chronic hepatitis C- genotype 1. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 569
• Est. completion date: February 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• adult patients 18-65 years of age

• CHC, genotype 1

• serologic evidence of CHC infection by an antibody test

• chronic liver disease, consistent with CHC infection on a liver biopsy obtained within the past 18 months

• compensated liver disease

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

Exclusion Criteria:

• previous interferon or ribavirin therapy

• systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study

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

• decompensated liver disease

• women who are pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy 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:
• Copegus
1000-1200mg po daily for 48 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms sc/week for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with sustained virologic response		24 weeks post-treatment	No
Secondary	Percentage of patients with early virologic response		Weeks 4 and 12	No
Secondary	Percentage of patients with virologic response		Weeks 4, 12, 24, 48 and 12 and 24 weeks post-treatment	No
Secondary	AEs, laboratory parameters, premature withdrawals		Throughout study	No