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Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus

NCT02098616 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2016-04-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.

Conditions

  • Hepatitis C

Interventions

DRUG

DCV/ASV/BMS-791325

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day

DRUG

DCV/ASV/BMS-791325 + RBV

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day

Sponsors & Collaborators

  • VA Long Beach Healthcare System

    collaborator FED

  • National Cancer Institute (NCI)

    collaborator NIH

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • Timothy Morgan, MD

    lead OTHER

Principal Investigators

  • Timothy R. Morgan, MD · VA Long Beach Healthcare System/Southern California Institute for Research and Education

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02098616 on ClinicalTrials.gov