Tucson, Arizona 85712

  • Hepatitis C, Chronic

Purpose:

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.


Criteria:

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 is Available At:


Original ID:

ML18179


NCT ID:

NCT00107653


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Hoffmann-La Roche


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

569


Enrollment Type:

Actual


Overall Contact Information

Official Name:Clinical Trials
Study Director
Hoffmann-La Roche

Study Dates

Start Date:August 2004
Completion Date:February 2008
Completion Type:Actual
Primary Completion Date:September 2007
Primary Completion Type:Actual
Verification Date:December 2015
Last Changed Date:December 1, 2015
First Received Date:April 6, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:AEs, laboratory parameters, premature withdrawals
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients with virologic response
Time Frame:Weeks 4, 12, 24, 48 and 12 and 24 weeks post-treatment
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Percentage of patients with early virologic response
Time Frame:Weeks 4 and 12
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Percentage of patients with sustained virologic response
Time Frame:24 weeks post-treatment
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Copegus
Description:1000-1200mg po daily for 48 weeks
Arm Name:1
Intervention Type:Drug
Name:peginterferon alfa-2a [Pegasys]
Description:180 micrograms sc/week for 48 weeks
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Hoffmann-La Roche

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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