NCT01051414

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

October 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.4 years

First QC Date

January 15, 2010

Last Update Submit

September 23, 2015

Conditions

Hepatitis C Infection

Outcome Measures

Primary Outcomes (2)

  • 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

    Week 4

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

    Post-treatment Week 12

Secondary Outcomes (5)

  • 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

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

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

    Week 4

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

    at both Weeks 4 and 12

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

    at follow-up Week 24

  • Resistant variants associated with clinical failure

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

Study Arms (1)

BMS-790052 + BMS-650032

EXPERIMENTAL
Drug: BMS-790052Drug: BMS-650032

Interventions

BMS-790052DRUG

Tablets, Oral, 60 mg, daily, 24 weeks

BMS-790052 + BMS-650032
BMS-650032DRUG

Tablets, Oral, 1200 mg, daily, 24 weeks

BMS-790052 + BMS-650032

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Local Institution

Hiroshima, Hiroshima, 734-0037, Japan

Location

Local Institution

Sapporo, Hokkaido, 060-0033, Japan

Location

Local Institution

Kawasaki-Shi, Kanagawa, 2138587, Japan

Location

Local Institution

Minato-Ku, Tokyo, 105-0001, Japan

Location

Related Publications (3)

  • 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.

    PMID: 26683763DERIVED

  • 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.

    PMID: 23183526DERIVED

  • 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.

    PMID: 23178977DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvirasunaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2010

First Posted

January 18, 2010

Study Start

April 1, 2010

Primary Completion

September 1, 2011

Study Completion

May 1, 2012

Last Updated

October 9, 2015

Record last verified: 2015-09

Locations

JP(4)