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Hepatitis C Antiviral Resistance in African-Americans

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
peginterferon alfa-2a
Ribavirin
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C, Interferon, Ribavirin, Efficacy, Viral load, Genetics, Cytokines, Immunology

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Francisco
  • University of Miami School of Medicine
  • Rush University
  • University of Maryland School of Medicine
  • Beth Israel Deaconess Medical Center
  • University of Michigan Medical Center
  • New York-Presbyterian Medical Center
  • University of North Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interferon and rivavirin

Arm Description

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.

Outcomes

Primary Outcome Measures

Sustained Virologic Response (SVR)
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.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2002
Last Updated
August 2, 2017
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00038974
Brief Title
Hepatitis C Antiviral Resistance in African-Americans
Official Title
Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), National Cancer Institute (NCI), National Center for Advancing Translational Sciences (NCATS), Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis C, Interferon, Ribavirin, Efficacy, Viral load, Genetics, Cytokines, Immunology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
401 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interferon and rivavirin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Primary Outcome Measure Information:
Title
Sustained Virologic Response (SVR)
Description
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.
Time Frame
24 weeks after therapy is discontinued

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Robuck
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
New York-Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data are available in the NIDDK Central Repository
IPD Sharing URL
https://www.niddkrepository.org/search/study/?q=virahep+c
Citations:
PubMed Identifier
16890601
Citation
Conjeevaram HS, Fried MW, Jeffers LJ, Terrault NA, Wiley-Lucas TE, Afdhal N, Brown RS, Belle SH, Hoofnagle JH, Kleiner DE, Howell CD; Virahep-C Study Group. Peginterferon and ribavirin treatment in African American and Caucasian American patients with hepatitis C genotype 1. Gastroenterology. 2006 Aug;131(2):470-7. doi: 10.1053/j.gastro.2006.06.008.
Results Reference
result
PubMed Identifier
22760009
Citation
Sarkar S, Jiang Z, Evon DM, Wahed AS, Hoofnagle JH. Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study. J Hepatol. 2012 Nov;57(5):946-52. doi: 10.1016/j.jhep.2012.06.030. Epub 2012 Jul 1.
Results Reference
derived
PubMed Identifier
19527724
Citation
Dove LM, Rosen RC, Ramcharran D, Wahed AS, Belle SH, Brown RS, Hoofnagle JH; Virahep-C Study Group. Decline in male sexual desire, function, and satisfaction during and after antiviral therapy for chronic hepatitis C. Gastroenterology. 2009 Sep;137(3):873-84, 884.e1. doi: 10.1053/j.gastro.2009.05.060. Epub 2009 Jun 13.
Results Reference
derived
PubMed Identifier
19284286
Citation
Hoofnagle JH, Wahed AS, Brown RS Jr, Howell CD, Belle SH; Virahep-C Study Group. Early changes in hepatitis C virus (HCV) levels in response to peginterferon and ribavirin treatment in patients with chronic HCV genotype 1 infection. J Infect Dis. 2009 Apr 15;199(8):1112-20. doi: 10.1086/597384.
Results Reference
derived
PubMed Identifier
18463735
Citation
Cannon NA, Donlin MJ, Fan X, Aurora R, Tavis JE; Virahep-C Study Group. Hepatitis C virus diversity and evolution in the full open-reading frame during antiviral therapy. PLoS One. 2008 May 7;3(5):e2123. doi: 10.1371/journal.pone.0002123.
Results Reference
derived

Learn more about this trial

Hepatitis C Antiviral Resistance in African-Americans

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