Phase 2b Study of BMS-986094 and Daclatasvir, With or Without Ribavirin for the Treatment of Patients With Chronic Hepatitis C

Hepatitis C Virus Clinical Trial

Official title:

Phase 2b Evaluation of PegIFNα Free Combinations of BMS-986094 (INX-08189) and Daclatasvir, With or Without Ribavirin, in Treatment Naive and Treatment Experienced Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01629732
• Other study ID #: AI472-007
• Secondary ID: 2012-002519-24
• Status: Withdrawn
• Phase: Phase 2
• First received: June 26, 2012
• Last updated: May 8, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: May 2014
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGermany: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of BMS-986094 and Daclatasvir (DCV) when given in combination with or without Ribavirin

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males and females, = 18 years of age

• Subjects chronically infected with Hepatitis C virus (HCV) genotype 1,2,3 or 4

• HCV RNA viral load = 10,000 IU/mL

• Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population)

• Body Mass Index (BMI) of 18 to 35 kg/m2

• Seronegative for Hepatitis C virus (HIV) and Hepatitis B

Exclusion Criteria:

• Evidence of decompensated liver disease

• Evidence of medical condition contributing to chronic liver disease other than HCV

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
• Daclatasvir
Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
• BMS-986094
Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
• BMS-986094
Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
• BMS-986094
Capsule, Oral, 200 mg, Once daily, 24 Weeks
• Ribavirin
Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
• Placebo for BMS-986094
Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks

Locations

Country	Name	City	State
United States	Local Institution	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with SVR4 defined as HCV RNA < LOQ (25 IU/mL; detectable or undetectable) at 4 weeks post treatment to be evaluated in GT1 (naive and NR) subjects randomized to the 12-week treatment arm (arms 1a, 2a, 3a, 4a)	SVR = Sustained virologic response; HCV = Hepatitis C virus; RNA = Ribonucleic acid; LOQ = Limit of quantitation	Follow up Week 4	No
Secondary	Proportion of treated subjects with SVR4 in genotype (GT) 1 naive and non-responder (NR) subjects randomized to the 24-week treatment arms (arms 1b, 2b, 3b, 4b)		Follow up Week 4 (SVR4)	No
Secondary	Proportion of treated subjects with SVR4 in genotype 1 protease inhibitor (PI)failures, genotype 4 naive, and genotype 2/3 NR/relapse subjects (arms 5, 6, 7)		Follow up Week 4 (SVR4)	No
Secondary	Proportion of treated subjects in each study population (GT1 naive, GT1 NR, or GT1 PI-failure, GT4 naive, GT2/3 NR/relapse), for each regimen and duration, who achieve HCV RNA < LOQ at post-treatment		Post-treatment Week 2 (SVR2), Week 8 (SVR8), Week 12 (SVR12), Week 24 (SVR24), and Week 36 (SVR36, for the 12 week arms)	No
Secondary	Proportion of treated subjects in each study population, by regimen, who achieve HCV RNA < LOQ (detectable/undetectable)		Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)	No
Secondary	Proportion of subjects in each study population, be regimen, who achieve HCV RNA undetectable		Weeks 1, 2, 4, 6, 8, 12 and End of Treatment (Week 12 or 24)	No
Secondary	Safety and tolerability of BMS-986094 and DCV ± RBV as measured by the frequency of deaths, serious adverse events (SAEs), discontinuations due to Adverse Events (AEs), and severity Grade 3/4 laboratory abnormalities		Up to post treatment Week 36	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form