NCT02123654

Brief Summary

The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA \< LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
297

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

35 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

Study Start

First participant enrolled

April 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 18, 2015

Status Verified

August 1, 2015

Enrollment Period

9 months

First QC Date

April 10, 2014

Last Update Submit

September 16, 2015

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12

    After 12 weeks of the last dose

Secondary Outcomes (10)

  • The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV

    Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  • The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325

    Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  • The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

    Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  • The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24

    Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  • On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities

    Approximately 48 weeks

  • +5 more secondary outcomes

Study Arms (3)

Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV

EXPERIMENTAL

DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)

Drug: DCV 3DAAOther: Placebo for DaclatasvirOther: Placebo for Asunaprevir

Arm 2: DCV/ASV + Placebo for DCV 3DAA

ACTIVE COMPARATOR

Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)

Drug: DaclatasvirDrug: AsunaprevirOther: Placebo for DCV 3DAA

DCV 3DAA

EXPERIMENTAL

DCV 3DAA (open label) Tablet orally twice daily for 12 weeks

Drug: DCV 3DAA

Interventions

DaclatasvirDRUG
Arm 2: DCV/ASV + Placebo for DCV 3DAA
AsunaprevirDRUG
Arm 2: DCV/ASV + Placebo for DCV 3DAA
DCV 3DAADRUG
Also known as: Daclatasvir 30 mg /Asunaprevir 200 mg /BMS-791325 75 mg fixed dose combination
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASVDCV 3DAA
Placebo for DCV 3DAAOTHER
Arm 2: DCV/ASV + Placebo for DCV 3DAA
Placebo for DaclatasvirOTHER
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV
Placebo for AsunaprevirOTHER
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV

Eligibility Criteria

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

You may qualify if:

  • Males and females, ≥ 20 years of age
  • Subjects chronically infected with HCV GT-1
  • HCV RNA viral load of ≥ 100,000 IU/mL

You may not qualify if:

  • 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 (35)

Local Institution

Nagoya, Aichi-ken, 466-8560, Japan

Location

Local Institution

Nagoya, Aichi-ken, 4678602, Japan

Location

Local Institution

Fukui-shi, Fukui, 9188503, Japan

Location

Local Institution

Fukuoka, Fukuoka, 8108563, Japan

Location

Local Institution

Kurume-shi, Fukuoka, 8300011, Japan

Location

Local Institution

Gifu, Gifu, 5008513, Japan

Location

Local Institution

Ogaki-shi, Gifu, 5038502, Japan

Location

Local Institution

Takasaki, Gunma, 3700829, Japan

Location

Local Institution

Hiroshima, Hiroshima, 7348551, Japan

Location

Local Institution

Sapporo, Hokkaido, 0600033, Japan

Location

Local Institution

Sapporo, Hokkaido, 0608648, Japan

Location

Local Institution

Kobe, Hyōgo, 6500047, 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

Yokohama, Kanagawa, 2320024, Japan

Location

Local Institution

Kumamoto, Kumamoto, 8628655, Japan

Location

Local Institution

Kyoto, Kyoto, 6028566, Japan

Location

Local Institution

Miyazaki, Miyazaki, 8800003, Japan

Location

Local Institution

Kashihara, Nara, 6348522, Japan

Location

Local Institution

Okayama, Okayama-ken, 7008558, Japan

Location

Local Institution

Osaka, Osaka, 5438555, Japan

Location

Local Institution

Osaka, Osaka, 5458586, Japan

Location

Local Institution

Suita, Osaka, 5640013, Japan

Location

Local Institution

Suita-shi, Osaka, 5650871, Japan

Location

Local Institution

Saga, Saga-ken, 8408571, Japan

Location

Local Institution

Iruma-gun, Saitama, 3500495, 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

Shinjuku-Ku, Tokyo, 1608582, Japan

Location

Local Institution

Yamagata, Yamagata, 9909585, Japan

Location

Local Institution

Chuo-shi, Yamanashi, 4093898, Japan

Location

Local Institution

Nishinomiya-shi, 6638501, Japan

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvirasunaprevir8-cyclohexyl-N-((dimethylamino)sulfonyl)-1,1a,2,12b-tetrahydro-11-methoxy-1a-((3-methyl-3,8-diazabicyclo(3.2.1)oct-8-yl)carbonyl)cycloprop(d)indolo(2,1-a)(2)benzazepine-5-carboxamide

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 25, 2014

Study Start

April 1, 2014

Primary Completion

January 1, 2015

Study Completion

August 1, 2015

Last Updated

September 18, 2015

Record last verified: 2015-08

Locations

JP(35)