Ribavirin Loading Dose or Priming and Concentration Targeting for HCV Genotype 1

Phase 3 Completed 105 enrolled Göteborg University Roche Pharma AG · collab The Swedish Research Council · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, parallel group, multicenter pilot study evaluating the efficacy and safety of alternative dosing of ribavirin vs. standard of care dosing in combination with peginterferon alpha-2a in interferon naïve patients with chronic hepatitis c genotype 1 infection.

Timeline

Start: 2010-09
Primary completion: 2014-09
Completion: 2014-09

Publications

Waldenstrom J, Westin J, Nystrom K, Christensen P, Dalgard O, Farkkila M, Lindahl K, Nilsson S, Norkrans G, Krarup H, Norrgren H, Rauning Buhl M, Stenmark S, Lagging M. Randomized Trial Evaluating the Impact of Ribavirin Mono-Therapy and Double Dosing on Viral Kinetics, Ribavirin Pharmacokinetics and Anemia in Hepatitis C Virus Genotype 1 Infection. PLoS One. 2016 May 11;11(5):e0155142. doi: 10.1371/journal.pone.0155142. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ribavirin	Small molecule	13 mg/kg	—
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	—

Ribavirin Loading Dose or Priming and Concentration Targeting for HCV Genotype 1

Summary

Timeline

Publications

Drugs

Indications