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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00107653
First received: April 6, 2005
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This single arm study will evaluate the efficacy and safety of PEGASYS (180 micr ograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive Latin

o patients versus non-Latino Caucasian patients with chronic hepatitis C- genoty pe 1. The anticipated time on study treatment is 3-12 months and the target samp le size is 500+ patients.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 Start Date: August 2004
Study Completion Date: February 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: peginterferon alfa-2a [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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00107653     History of Changes
Other Study ID Numbers: ML18179
Study First Received: April 6, 2005
Last Updated: August 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014