Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus (RHACE 1)

April 15, 2016 updated by: Timothy Morgan, MD

RHACE 1: Rapid HepAtitis C Elimination Trial - A Pilot Evaluation of Twice Daily Fixed Dose Combination Asunaprevir +Daclatasvir + BMS-791325 ± Weight Based Ribavirin in Treatment-Naïve, Non-cirrhotic Patients With Chronic Genotype 1a Hepatitis-C for Eight, Six or Four Weeks

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1a
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)

Exclusion Criteria:

  • Evidence of cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to enrollment
  • Documented or suspected hepatocellular carcinoma (HCC)
  • Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks
Drug: DCV/ASV/BMS-791325
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
Other Names:
  • Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325
Experimental: Arm 2
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks
Drug: DCV/ASV/BMS-791325
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
Other Names:
  • Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325
Experimental: Arm 3
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks
Drug: DCV/ASV/BMS-791325
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
Other Names:
  • Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325
Experimental: Arm A
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 for 8 weeks
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
Experimental: Arm B
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 for 6, 8 or 12 weeks
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
Experimental: Arm C
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 for 4 weeks
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Virologic Response
Time Frame: Post treatment week 12
Proportion of treated subjects in each enrolled arm with sustained virologic response (SVR)12. SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Week 12
Post treatment week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: Up to end of treatment (+7 days)
On treatment safety, as measured by frequency of serious adverse events (SAEs) and adverse events (AEs), discontinuations due to AEs, and rates and grades of select laboratory abnormalities including liver function tests and hematology laboratory abnormalities in each arm
Up to end of treatment (+7 days)
Sustained virologic response
Time Frame: 2, 4 and 24 weeks post-treatment
Proportion of treated subjects in each arm with SVR2, SVR4 and SVR 24, defined as HCV RNA < lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Weeks, 2, 4, and 24 respectively
2, 4 and 24 weeks post-treatment
Post treatment virologic response
Time Frame: post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)
To assess the proportion of subjects who achieve sustained virologic response (SVR) 2, SVR4 and SVR24.
post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)
On treatment virologic response
Time Frame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12
To assess antiviral activity, as measured by the proportion of subjects who achieve HCV RNA <lower limit of detection (LLOD) and/or < lower limit of quantification (LLOQ) at each on treatment visit.
On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12
Virologic failure
Time Frame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
To assess the proportion of subjects with virologic failure (including on treatment virologic breakthrough and relapse) and evaluate the emergence of viral resistant mutations.
On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
Day 2 positive predictive value
Time Frame: Post treatment Week 12
To assess the predictive value of Day 2 virologic response on sustained virologic response (SVR) 12
Post treatment Week 12
Interferon lambda genotype and virologic response
Time Frame: On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
To compare the virologic response of subjects by genotype for interferon (IFN) lambda variants [' IL28B' and IFNL4-ΔG]
On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timothy Morgan, MD

Collaborators

Bristol-Myers Squibb
National Cancer Institute (NCI)
VA Long Beach Healthcare System

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #1285
  • AI443-128 (Other Grant/Funding Number: Bristol-Myers Squibb)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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