ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 3155 for:    "Hepatitis, Viral, Human"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02098616
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : April 19, 2016
Sponsor:
Collaborators:
VA Long Beach Healthcare System
National Cancer Institute (NCI)
Bristol-Myers Squibb
Information provided by (Responsible Party):
Timothy Morgan, MD, Southern California Institute for Research and Education

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: DCV/ASV/BMS-791325 Drug: DCV/ASV/BMS-791325 + RBV Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098616


Locations
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Sponsors and Collaborators
Timothy Morgan, MD
VA Long Beach Healthcare System
National Cancer Institute (NCI)
Bristol-Myers Squibb
Investigators
Principal Investigator: Timothy R. Morgan, MD VA Long Beach Healthcare System/Southern California Institute for Research and Education

Responsible Party: Timothy Morgan, MD, Chief, Hepatology, Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT02098616     History of Changes
Other Study ID Numbers: IRB #1285
AI443-128 ( Other Grant/Funding Number: Bristol-Myers Squibb )
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Timothy Morgan, MD, Southern California Institute for Research and Education:
Hepatitis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Antiviral Agents
Drug Resistance, Viral

Additional relevant MeSH terms:
Hepatitis, Viral, Human
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents