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: October 6, 2014
Last verified: October 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: Copegus
Drug: peginterferon alfa-2a [Pegasys]
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: Copegus
1000-1200mg po daily for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc/week 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

  Hide Study Locations
Locations
United States, Arizona
Scottsdale, Arizona, United States, 85259
Tucson, Arizona, United States, 85712
United States, California
Anaheim, California, United States, 92801
Fountain Valley, California, United States, 92708
Fresno, California, United States, 93721
Lancaster, California, United States, 93534
Los Angeles, California, United States, 90033
Los Angeles, California, United States, 90022
Los Angeles, California, United States, 90095
Palo Alto, California, United States, 94304-1509
Redlands, California, United States, 92373
Sacramento, California, United States, 95817
San Bernardino, California, United States, 92404
San Diego, California, United States, 92103-8465
San Diego, California, United States, 92123
San Diego, California, United States, 92161
San Diego, California, United States, 92154
San Francisco, California, United States, 94110
San Luis Obispo, California, United States, 93401
Ventura, California, United States, 93003
United States, Colorado
Pueblo, Colorado, United States, 81008
United States, Florida
Boca Raton, Florida, United States, 33428
Bradenton, Florida, United States, 34209
Miami, Florida, United States, 33125
North Miami Beach, Florida, United States, 33162
Plantation, Florida, United States, 33324
United States, Georgia
Austell, Georgia, United States, 30106
United States, Illinois
Chicago, Illinois, United States, 60612
Chicago, Illinois, United States, 60637
Gurnee, Illinois, United States, 60031
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Baton Rouge, Louisiana, United States, 70890
New Orleans, Louisiana, United States, 70115
United States, Maryland
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Framingham, Massachusetts, United States, 01702
Worcester, Massachusetts, United States, 01655
United States, Missouri
St Louis, Missouri, United States, 63110
United States, New Jersey
Vineland, New Jersey, United States, 08360
United States, New York
Bayside, New York, United States, 11358
New York, New York, United States, 10029
Rochester, New York, United States, 14618
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7584
Fayetteville, North Carolina, United States, 28304
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19141
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Nashville, Tennessee, United States, 37211
United States, Texas
Dallas, Texas, United States, 75203
Fort Sam Houston, Texas, United States, 78234-3879
Fort Worth, Texas, United States, 76107
Galveston, Texas, United States, 77555
Houston, Texas, United States, 77090
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78258
San Antonio, Texas, United States, 78215
United States, Utah
Salt Lake City, Utah, United States, 84121
United States, Virginia
Fairfax, Virginia, United States, 22031
United States, Washington
Seattle, Washington, United States, 98133
Tacoma, Washington, United States, 98405
Puerto Rico
Ponce, Puerto Rico, 00716
Santurce, Puerto Rico, 00909
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: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 22, 2014