NCT00038974

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2002

Typical duration for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2002

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2002

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

2.3 years

First QC Date

June 5, 2002

Last Update Submit

August 2, 2017

Conditions

Hepatitis C

Keywords

Hepatitis CInterferonRibavirinEfficacyViral loadGeneticsCytokinesImmunology

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks after therapy is discontinued

Study Arms (1)

Interferon and rivavirin

EXPERIMENTAL

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-2aDrug: Ribavirin

Interventions

peginterferon alfa-2aDRUG
Interferon and rivavirin
RibavirinDRUG
Interferon and rivavirin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

University of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

New York-Presbyterian Medical Center

New York, New York, 10032, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (5)

  • 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.

    PMID: 16890601RESULT

  • 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.

    PMID: 22760009DERIVED

  • 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.

    PMID: 19527724DERIVED

  • 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.

    PMID: 19284286DERIVED

  • 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.

    PMID: 18463735DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon alfa-2aRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Patricia Robuck

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2002

First Posted

June 10, 2002

Study Start

August 1, 2002

Primary Completion

December 1, 2004

Study Completion

November 1, 2005

Last Updated

August 3, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Individual participant data are available in the NIDDK Central Repository

Shared Documents
STUDY PROTOCOL, ICF, CSR
More information

Locations

US(8)