Hepatitis C Antiviral Resistance in African-Americans

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00038974
First received: June 5, 2002
Last updated: March 15, 2011
Last verified: March 2011
  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: Pegylated interferon
Drug: Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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):

Estimated Enrollment: 400
Study Start Date: August 2002
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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
  More Information

Additional Information:
No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00038974     History of Changes
Other Study ID Numbers: Virahep-C (completed), U01 DK60329
Study First Received: June 5, 2002
Last Updated: March 15, 2011
Health Authority: United States: Food and Drug Administration

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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014