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An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

Primary Purpose

Hepatitis C Infection

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

BMS-790052

BMS-650032

About this trial

This is an interventional treatment trial for Hepatitis C Infection

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects chronically infected with HCV Genotype 1
HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening

Exclusion Criteria:

Subjects with evidence of liver cirrhosis
Evidence of HCC
Co-infection with hepatitis B virus, HIV

Sites / Locations

Local Institution
Local Institution
Local Institution
Local Institution

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BMS-790052 + BMS-650032

Arm Description

Outcomes

Primary Outcome Measures

Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs

Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12)

Secondary Outcome Measures

The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities

The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL

The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL

The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL

Resistant variants associated with clinical failure

Full Information

NCT ID

NCT01051414

First Posted

January 15, 2010

Last Updated

September 23, 2015

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01051414

Brief Title

An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

Official Title

A Phase 2a Study of BMS-790052 and BMS-650032 in Combination Therapy With Japanese Subjects With Genotype 1 Chronic Hepatitis C (HCV) Virus Infection

Study Type

Interventional

2. Study Status

Record Verification Date

September 2015

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To assess the efficacy and safety profile of co-administration of BMS-790052 and BMS-650032 for 24 weeks treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BMS-790052 + BMS-650032

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BMS-790052

Intervention Description

Tablets, Oral, 60 mg, daily, 24 weeks

Intervention Type

Drug

Intervention Name(s)

BMS-650032

Intervention Description

Tablets, Oral, 1200 mg, daily, 24 weeks

Primary Outcome Measure Information:

Title

Part 1: To assess safety and tolerability based on 4 weeks safety data, as measured by related serious adverse events (SAEs) and discontinuations due to related AEs

Time Frame

Week 4

Title

Part 2: To determine the proportion of subjects who achieve SVR12 (i.e., HCV RNA < 15 IU/mL at follow-up Week 12)

Time Frame

Post-treatment Week 12

Secondary Outcome Measure Information:

Title

The safety of co-administration of BMS-790052 + BMS-650032 as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities

Time Frame

Weeks 4, 12, end of treatment and post-treatment Week 24

Title

The proportion of subjects who achieve RVR (defined as HCV RNA < 15 IU/mL

Time Frame

Week 4

Title

The proportion of subjects with extended rapid virologic response (eRVR), defined as HCV RNA < 15 IU/mL

Time Frame

at both Weeks 4 and 12

Title

The proportion of subjects who achieve SVR24 (defined as HCV RNA < 15 IU/mL

Time Frame

at follow-up Week 24

Title

Resistant variants associated with clinical failure

Time Frame

Weeks 4, 12, end of treatment and post-treatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects chronically infected with HCV Genotype 1 HCV RNA viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening Exclusion Criteria: Subjects with evidence of liver cirrhosis Evidence of HCC Co-infection with hepatitis B virus, HIV

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Hiroshima City

State/Province

Hiroshima

ZIP/Postal Code

734-0037

Country

Japan

Facility Name

Local Institution

City

Sapporo-Shi

State/Province

Hokkaido

ZIP/Postal Code

060-0033

Country

Japan

Facility Name

Local Institution

City

Kawasaki-Shi

State/Province

Kanagawa

ZIP/Postal Code

2138587

Country

Japan

Facility Name

Local Institution

City

Minato-Ku

State/Province

Tokyo

ZIP/Postal Code

105-0001

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

26683763

Citation

Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.

Results Reference

derived

PubMed Identifier

23183526

Citation

Suzuki Y, Ikeda K, Suzuki F, Toyota J, Karino Y, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hu W, Eley T, McPhee F, Hughes E, Kumada H. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol. 2013 Apr;58(4):655-62. doi: 10.1016/j.jhep.2012.09.037. Epub 2012 Nov 23.

Results Reference

derived

PubMed Identifier

23178977

Citation

Karino Y, Toyota J, Ikeda K, Suzuki F, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hernandez D, Yu F, McPhee F, Kumada H. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol. 2013 Apr;58(4):646-54. doi: 10.1016/j.jhep.2012.11.012. Epub 2012 Nov 22.

Results Reference

derived

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An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject

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