NCT00038974

Study of Viral Resistance to Antiviral Therapy of Chronic Hepatitis C (Virahep-C)

Completed Phase 3 Last updated 2 August 2017

What this trial tests

Phase 3 trial testing peginterferon alfa-2a in Hepatitis C in 401 participants. Completed in 1 November 2005.

Timeline

1 August 2002

Primary endpoint
1 December 2004

1 November 2005

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	401
Start date	1 August 2002
Primary completion	1 December 2004
Estimated completion	1 November 2005
Sites	8 locations across United States

Drugs / interventions tested

• peginterferon alfa-2a (PEGINTERFERON ALFA-2A) — full drug profile →
• Ribavirin — full drug profile →

Conditions studied

• Hepatitis C — all drugs for Hepatitis C →

Sponsor

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

Who can join

Adults 18 to 70, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Response-guided telaprevir combination treatment for hepatitis C virus infection.
   Sherman KE, Flamm SL, Afdhal NH, Nelson DR, et al · · 2011 · cited 542× · PMID 21916639 · DOI 10.1056/nejmoa1014463
2. Variants in the ITPA gene protect against ribavirin-induced hemolytic anemia and decrease the need for ribavirin dose reduction.
   Thompson AJ, Fellay J, Patel K, Tillmann HL, et al · · 2010 · cited 149× · PMID 20547162 · DOI 10.1053/j.gastro.2010.06.016
3. Fatigue before, during and after antiviral therapy of chronic hepatitis C: results from the Virahep-C study.
   Sarkar S, Jiang Z, Evon DM, Wahed AS, et al · · 2012 · cited 47× · PMID 22760009 · DOI 10.1016/j.jhep.2012.06.030
4. Hepatitis C virus diversity and evolution in the full open-reading frame during antiviral therapy.
   Cannon NA, Donlin MJ, Fan X, Aurora R, et al · · 2008 · cited 35× · PMID 18463735 · DOI 10.1371/journal.pone.0002123
5. Early changes in hepatitis C virus (HCV) levels in response to peginterferon and ribavirin treatment in patients with chronic HCV genotype 1 infection.
   Hoofnagle JH, Wahed AS, Brown RS, Howell CD, et al · · 2009 · cited 34× · PMID 19284286 · DOI 10.1086/597384
6. A novel unsupervised method to identify genes important in the anti-viral response: application to interferon/ribavirin in hepatitis C patients.
   Brodsky LI, Wahed AS, Li J, Tavis JE, et al · · 2007 · cited 19× · PMID 17589564 · DOI 10.1371/journal.pone.0000584
7. Vitamin D Status and Virologic Response to HCV Therapy in the HALT-C and VIRAHEP-C Trials.
   Loftfield E, O'Brien TR, Pfeiffer RM, Howell CD, et al · · 2016 · cited 8× · PMID 27832143 · DOI 10.1371/journal.pone.0166036