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Hepatitis C Antiviral Resistance in African-Americans

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00038974
First Posted: June 10, 2002
Last Update Posted: August 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute on Minority Health and Health Disparities (NIMHD)
National Cancer Institute (NCI)
National Center for Advancing Translational Science (NCATS)
Hoffmann-La Roche
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose
This study is designed to test the hypothesis that African-Americans respond less well to combination pegylated interferon and ribavirin therapy than Caucasian-Americans who have chronic hepatitis C genotype 1 and who were not previously treated with either interferon or ribavirin. Reasons for differences in response, regardless of race, will be studied.

Condition Intervention Phase
Hepatitis C Drug: peginterferon alfa-2a Drug: Ribavirin Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Sustained Virologic Response (SVR) [ Time Frame: 24 weeks after therapy is discontinued ]
    The primary end point of therapy was an SVR that was definied as the absences of detectable HCV RNA in serum 24 weeks after therapy was stopped.


Enrollment: 401
Study Start Date: August 2002
Study Completion Date: November 2005
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interferon and rivavirin
All patients received peginterferon alfa-2a in a dose of 180 μg weekly and ribavirin in a dose of 1000 (for patients with a body weight of ⩽75 kg) or 1200 mg (for those with a body weight of >75 kg) daily.
Drug: peginterferon alfa-2a Drug: Ribavirin

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  • Age between 18 and 70 years at screening
  • Black/African American or White/Caucasian
  • Born in the United States
  • Quantifiable Serum HCV RNA
  • Hepatitis C genotype 1
  • Liver biopsy consistent with chronic hepatitis C
  • Negative urine pregnancy test
  • Males and Females must be using two reliable forms of effective contraception while on drug and during follow-up.

Exclusion:

  • Previous treatment with interferon or ribavirin
  • Positive test at screening for anti-HIV
  • Positive test for HBsAg
  • Alcohol consumption of more than two drinks/day
  • History of other chronic liver disease
  • Pregnant or breast-feeding women
  • Male partners of women who are pregnant or contemplating pregnancy
  • Neutrophil count <1000 cells/mm3
  • Hgb <11 g/dl in women or 12 g/dl in men
  • Platelet count <75,000 cells/mm3.
  • Thalassemia, spherocytosis, history of GI bleeding or those at increased risk of anemia
  • Serum creatinine level >1.5 times the upper limit of normal at screening or CrCl < 75cc/min
  • Current dialysis
  • Alcohol or drug abuse within 6 months
  • Current (<6 months)severe psychiatric disorder
  • History of immunologically mediated disease
  • Decompensated liver disease
  • High risk cardiovascular/coronary artery disease
  • Severe seizure disorder or anticonvulsant use
  • Solid organ or bone marrow transplantation
  • Thyroid disease poorly controlled on prescribed medications
  • History or other evidence of retinopathy
  • Chronic use of oral steroids
  • Inability or unwillingness to provide informed consent or abide by the study protocol
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038974


Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
United States, New York
New York-Presbyterian Medical Center
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Minority Health and Health Disparities (NIMHD)
National Cancer Institute (NCI)
National Center for Advancing Translational Science (NCATS)
Hoffmann-La Roche
Investigators
Study Director: Patricia Robuck National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00038974     History of Changes
Other Study ID Numbers: Virahep-C (completed)
U01DK060329 ( U.S. NIH Grant/Contract )
U01DK060340 ( U.S. NIH Grant/Contract )
U01DK060324 ( U.S. NIH Grant/Contract )
U01DK060344 ( U.S. NIH Grant/Contract )
U01DK060327 ( U.S. NIH Grant/Contract )
U01DK060335 ( U.S. NIH Grant/Contract )
U01DK060352 ( U.S. NIH Grant/Contract )
U01DK060342 ( U.S. NIH Grant/Contract )
U01DK060345 ( U.S. NIH Grant/Contract )
U01DK060309 ( U.S. NIH Grant/Contract )
U01DK060346 ( U.S. NIH Grant/Contract )
U01DK060349 ( U.S. NIH Grant/Contract )
U01DK060341 ( U.S. NIH Grant/Contract )
First Submitted: June 5, 2002
First Posted: June 10, 2002
Last Update Posted: August 3, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data are available in the NIDDK Central Repository
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
URL: https://www.niddkrepository.org/search/study/?q=virahep+c

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Hepatitis C
Interferon
Ribavirin
Efficacy
Viral load
Genetics
Cytokines
Immunology

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