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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 (RHACE 1)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DCV/ASV/BMS-791325
DCV/ASV/BMS-791325 + RBV
Sponsored by
Timothy Morgan, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Antiviral Agents, Drug Resistance, Viral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Long Beach Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm A

Arm B

Arm C

Arm Description

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks

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

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks

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

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

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

Outcomes

Primary Outcome Measures

Sustained Virologic Response
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

Secondary Outcome Measures

Safety
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
Sustained virologic response
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
Post treatment virologic response
To assess the proportion of subjects who achieve sustained virologic response (SVR) 2, SVR4 and SVR24.
On treatment virologic response
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.
Virologic failure
To assess the proportion of subjects with virologic failure (including on treatment virologic breakthrough and relapse) and evaluate the emergence of viral resistant mutations.
Day 2 positive predictive value
To assess the predictive value of Day 2 virologic response on sustained virologic response (SVR) 12
Interferon lambda genotype and virologic response
To compare the virologic response of subjects by genotype for interferon (IFN) lambda variants [' IL28B' and IFNL4-ΔG]

Full Information

First Posted
March 25, 2014
Last Updated
April 15, 2016
Sponsor
Timothy Morgan, MD
Collaborators
VA Long Beach Healthcare System, National Cancer Institute (NCI), Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02098616
Brief Title
Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus
Acronym
RHACE 1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Timothy Morgan, MD
Collaborators
VA Long Beach Healthcare System, National Cancer Institute (NCI), Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Hepatitis, Hepatitis, Chronic, Hepatitis C, Hepatitis C, Chronic, Liver Diseases, Digestive System Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Antiviral Agents, Drug Resistance, Viral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks
Arm Title
Arm A
Arm Type
Experimental
Arm Description
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
Arm Title
Arm B
Arm Type
Experimental
Arm Description
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
Arm Title
Arm C
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
DCV/ASV/BMS-791325
Other Intervention Name(s)
Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325
Intervention Description
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
Intervention Type
Drug
Intervention Name(s)
DCV/ASV/BMS-791325 + RBV
Intervention Description
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
Primary Outcome Measure Information:
Title
Sustained Virologic Response
Description
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
Time Frame
Post treatment week 12
Secondary Outcome Measure Information:
Title
Safety
Description
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
Time Frame
Up to end of treatment (+7 days)
Title
Sustained virologic response
Description
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
Time Frame
2, 4 and 24 weeks post-treatment
Title
Post treatment virologic response
Description
To assess the proportion of subjects who achieve sustained virologic response (SVR) 2, SVR4 and SVR24.
Time Frame
post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)
Title
On treatment virologic response
Description
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.
Time Frame
On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12
Title
Virologic failure
Description
To assess the proportion of subjects with virologic failure (including on treatment virologic breakthrough and relapse) and evaluate the emergence of viral resistant mutations.
Time Frame
On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24
Title
Day 2 positive predictive value
Description
To assess the predictive value of Day 2 virologic response on sustained virologic response (SVR) 12
Time Frame
Post treatment Week 12
Title
Interferon lambda genotype and virologic response
Description
To compare the virologic response of subjects by genotype for interferon (IFN) lambda variants [' IL28B' and IFNL4-ΔG]
Time Frame
On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy R. Morgan, MD
Organizational Affiliation
VA Long Beach Healthcare System/Southern California Institute for Research and Education
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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