NCT01497834

Brief Summary

The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

24 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

December 2, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 23, 2011

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

December 2, 2011

Last Update Submit

September 23, 2015

Conditions

Hepatitis C

Keywords

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Antiviral activity, as determined by the proportion of subjects with SVR24

    SVR24 - sustained virologic response at follow-up Week 24 (after end of treatment)

    After 24 weeks of the last dose

Secondary Outcomes (4)

  • Antiviral activity, as determined by the proportion of subjects who achieve Hepatitis C virus (HCV) ribonucleic acid (RNA) below lower limit of quantitation (LLOQ) target detected or not detected

    Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; End of treatment (EOT), or post treatment Week 12

  • Antiviral activity, as determined by the proportion of subjects who achieve HCV RNA below LLOQ, target not detected

    Weeks 1, 2, 4, 6, 8, 10 and 12; Weeks 4 and 12; EOT, or post treatment Week 12, post treatment Week 24

  • Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), AEs by intensity and laboratory abnormalities by toxicity grade

    End of treatment plus 7 days

  • Proportion of subjects with SVR24 by IL28B status [CC, CT, or TT genotype at the IL28B rs12979860 single nucleotide polymorphisms (SNP)]

    Follow-up Week 24

Study Arms (1)

Daclatasvir + Asunaprevir

EXPERIMENTAL
Drug: BMS-790052 (Daclatasvir)Drug: BMS-650032 (Asunaprevir)

Interventions

BMS-790052 (Daclatasvir)DRUG

Tablets, Oral, 60mg, Once daily, 24 weeks

Daclatasvir + Asunaprevir
BMS-650032 (Asunaprevir)DRUG

Capsules, Oral, 100mg, Twice daily, 24 weeks

Daclatasvir + Asunaprevir

Eligibility Criteria

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

You may qualify if:

  • Chronic HCV-1b infected patient
  • HCV RNA viral load of ≥ 100,000 IU/mL at screening
  • Ages 20 to 75 years
  • Non-responder to Interferon plus Ribavirin therapy
  • Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

You may not qualify if:

  • Patients who have -
  • Hepatocellular carcinoma
  • Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
  • Severe or uncontrollable complication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Local Institution

Nagoya, Aichi-ken, 4668560, Japan

Location

Local Institution

Chiba, Chiba, 2608677, Japan

Location

Local Institution

Fukuoka, Fukuoka, 8108563, Japan

Location

Local Institution

Kurume, Fukuoka, 8300011, Japan

Location

Local Institution

Ogaki-shi, Gifu, 5038502, Japan

Location

Local Institution

Hiroshima, Hiroshima, 7340037, Japan

Location

Local Institution

Sapporo, Hokkaido, 0600033, Japan

Location

Local Institution

Amagasaki-shi, Hyōgo, 6608511, Japan

Location

Local Institution

Kanazawa, Ishikawa-ken, 9208641, Japan

Location

Local Institution

Takamatsu, Kagawa-ken, 7608557, Japan

Location

Local Institution

Kagoshima, Kagoshima-ken, 8908520, Japan

Location

Local Institution

Kawasaki-Shi, Kanagawa, 2138587, Japan

Location

Local Institution

Sendai, Miyagi, 9808574, Japan

Location

Local Institution

Okayama, Okayama-ken, 7008558, Japan

Location

Local Institution

Osaka, Osaka, 5458586, Japan

Location

Local Institution

Osaka-sayama-shi, Osaka, 5898511, Japan

Location

Local Institution

Suita, Osaka, 5640013, Japan

Location

Local Institution

Suita-shi, Osaka, 5650871, Japan

Location

Local Institution

Iruma-Gun, Saitama, 350-0495, Japan

Location

Local Institution

Bunkyo-Ku, Tokyo, 1138655, Japan

Location

Local Institution

Minato-ku, Tokyo, 1058470, Japan

Location

Local Institution

Musashino-shi, Tokyo, 1808610, Japan

Location

Local Institution

Shinagawa-ku, Tokyo, 1428666, Japan

Location

Local Institution

Chuo-shi, Yamanashi, 4093898, Japan

Location

Related Publications (3)

  • Hernandez D, Yu F, Huang X, Kirov S, Pant S, McPhee F. Impact of Pre-existing NS5A-L31 or -Y93H Minor Variants on Response Rates in Patients Infected with HCV Genotype-1b Treated with Daclatasvir/Asunaprevir. Adv Ther. 2016 Jul;33(7):1169-79. doi: 10.1007/s12325-016-0354-1. Epub 2016 Jun 10.

    PMID: 27287851DERIVED

  • 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

  • Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Kawakami Y, Ido A, Yamamoto K, Takaguchi K, Izumi N, Koike K, Takehara T, Kawada N, Sata M, Miyagoshi H, Eley T, McPhee F, Damokosh A, Ishikawa H, Hughes E. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014 Jun;59(6):2083-91. doi: 10.1002/hep.27113. Epub 2014 Apr 1.

    PMID: 24604476DERIVED

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 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 23, 2011

Study Start

January 1, 2012

Primary Completion

April 1, 2013

Study Completion

June 1, 2013

Last Updated

October 9, 2015

Record last verified: 2015-09

Locations

JP(24)