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

Hepatitis C Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098616
• Other study ID #: IRB #1285
• Secondary ID: AI443-128
• Status: Completed
• Phase: N/A
• First received: March 25, 2014
• Last updated: April 15, 2016
• Start date: July 2014
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Southern California Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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, IFNa, pegIFNa), 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• DCV/ASV/BMS-791325
Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
• 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

Locations

Country	Name	City	State
United States	VA Long Beach Healthcare System	Long Beach	California

Sponsors (4)

Lead Sponsor	Collaborator
Timothy Morgan, MD	Bristol-Myers Squibb, National Cancer Institute (NCI), VA Long Beach Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post treatment week 12	No
Secondary	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	Up to end of treatment (+7 days)	Yes
Secondary	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	2, 4 and 24 weeks post-treatment	No
Secondary	Post treatment virologic response	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)	No
Secondary	On treatment virologic response	To assess antiviral activity, as measured by the proportion of subjects who achieve HCV RNA	On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12	No
Secondary	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.	On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24	No
Secondary	Day 2 positive predictive value	To assess the predictive value of Day 2 virologic response on sustained virologic response (SVR) 12	Post treatment Week 12	No
Secondary	Interferon lambda genotype and virologic response	To compare the virologic response of subjects by genotype for interferon (IFN) lambda variants [' IL28B' and IFNL4-?G]	On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24	No