Skip to main content
OpenTrials
Completed

NCT Number: NCT02098616

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DCV/ASV/BMS-791325

Drug

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

DCV/ASV/BMS-791325 + RBV

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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]

Sponsors and collaborators

Lead sponsor

Timothy Morgan, MD

Other

Collaborators

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

Registry information

Official study 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

Acronym: RHACE 1

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.