Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients

Phase 2

Completed

• Conditions: Hepatitis C Infection
• Interventions: Drug: Placebo; Drug: BMS-790052; Drug: Peginterferon alfa-2b; Drug: Ribavirin

• Registration Number: NCT01016912
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-19
• Study First Submitted QC: 2009-11-19
• Study First Posted: 2009-11-20
• Study Start: 2009-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Results First Submitted: 2015-08-17
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Results First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Patients chronically infected with hepatitis C virus (HCV) genotype 1
• HCV RNA viral load ≥10*5* IU/mL at screening
• Naïve or nonresponsive to the current standard of care

Key

Exclusion Criteria

• Cirrhosis
• Hepatocellular carcinoma
• Coinfection with hepatitis B virus, HIV-1 or HIV-2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)	Placebo	Treatment Naive
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)	Peginterferon alfa-2b	Treatment Naive
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Ribavirin	Non-Responder
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	BMS-790052	Treatment Naive
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Ribavirin	Treatment Naive
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	BMS-790052	Treatment Naive
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Ribavirin	Treatment Naive
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)	Ribavirin	Treatment Naive
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)	BMS-790052	Non-Responder
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)	Ribavirin	Non-Responder
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	BMS-790052	Non-Responder
Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Peginterferon alfa-2b	Treatment Naive
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Peginterferon alfa-2b	Non-Responder
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)	Peginterferon alfa-2b	Treatment Naive
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)	Peginterferon alfa-2b	Non-Responder

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Extended Rapid Virologic Response (eRVR)	At Weeks 4 and 12 on treatment	eRVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at both Weeks 4 and 12. HCV RNA levels were measured by Tobas TaqMan HCV Auto from the central laboratory.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Rapid Virologic Response (RVR)	At Week 4 on treatment	RVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 4. HCV RNA levels were measured by CobasTaqMan HCV Auto from the central laboratory .
Percentage of Participants With Complete Early Virologic Response (cEVR)	At Week 12 on treatment	cEVR was defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at Week 12 on treatment. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory
Percentage of Participants With a Sustained Virologic Response (SVR) at Weeks 4, 12, and 24	Follow-up Weeks 4, 12, and 24	SVR at follow-up Week 4 (SVR4), follow-up Week 12 (SVR12), and follow-up Week 24 (SVR24) is defined as undetectable hepatitis C virus (HCV) RNA (ie, HCV RNA \<15 IU/mL, the lower limit of detection, target not detected) at each of these timepoints. HCV RNA levels were measured by Cobas TaqMan HCV Auto from the central laboratory .
Percentage of Participants With Virologic Failure	From on-treatment Week 1 to Follow-up Week 24	Virologic failure is defined by the following 6 categories: 1.Virologic breakthrough, defined as confirmed \>1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed HCV RNA ≥limit of quantitation (LOQ) after confirmed undetectable HCV RNA while on treatment. 2. \<1 log10 decrease in HCV RNA from baseline at Week 4 of treatment. 3. Failure to achieve early virologic response, defined as \<2 log10 decrease in HCV RNA from baseline at Week 12 of treatment. 4. Detectable HCV RNA at Week 12, and HCV RNA ≥LOQ at Week 24 of treatment. 5. Detectable HCV RNA at end of treatment (including early discontinuation). 6 Relapse, defined as detectable HCV RNA during follow-up after undetectable HCV RNA levels at end of treatment.

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Minato-Ku, Tokyo, Japan