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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00107653

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.

Condition	Intervention	Phase
Hepatitis C, Chronic	Drug: peginterferon alfa-2a (40KD) [PEGASYS] Drug: Copegus	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Percentage of patients with sustained virologic response [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with early virologic response [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: No ]
Percentage of patients with virologic response [ Time Frame: Weeks 4, 12, 24, 48 and 12 and 24 weeks post-treatment ] [ Designated as safety issue: No ]
AEs, laboratory parameters, premature withdrawals [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	569
Study Completion Date:	March 2006

Arms	Assigned Interventions
1: Experimental	Drug: peginterferon alfa-2a (40KD) [PEGASYS] 180 micrograms sc/week for 48 weeks Drug: Copegus 1000-1200mg po daily for 48 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00107653

Show 60 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML18179
Study First Received:	April 6, 2005
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00107653
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Growth Substances
Therapeutic Uses

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009