NCT02098616

Brief Summary

The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

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

March 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

March 25, 2014

Last Update Submit

April 15, 2016

Conditions

Hepatitis C

Keywords

HepatitisHepatitis, ChronicHepatitis CHepatitis C, ChronicLiver DiseasesDigestive System DiseasesHepatitis, Viral, HumanRNA Virus InfectionsAntiviral AgentsDrug Resistance, Viral

Outcome Measures

Primary Outcomes (1)

  • Sustained Virologic Response

    Proportion of treated subjects in each enrolled arm with sustained virologic response (SVR)12. SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) target detected or target not detected (TD/TND) at post treatment Week 12

    Post treatment week 12

Secondary Outcomes (7)

  • Safety

    Up to end of treatment (+7 days)

  • Sustained virologic response

    2, 4 and 24 weeks post-treatment

  • Post treatment virologic response

    post treatment Weeks 2 (SVR2), 4 (SVR4), and 24 (SVR24)

  • On treatment virologic response

    On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12

  • Virologic failure

    On-treatment Day 2 and Weeks 1, 2, 4, 6, 8 and 12 and Post Treatment Weeks 2, 4, 12 and 24

  • +2 more secondary outcomes

Study Arms (6)

Arm 1

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks

Drug: DCV/ASV/BMS-791325

Arm 2

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks

Drug: DCV/ASV/BMS-791325

Arm 3

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks

Drug: DCV/ASV/BMS-791325

Arm A

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks

Drug: DCV/ASV/BMS-791325 + RBV

Arm B

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks

Drug: DCV/ASV/BMS-791325 + RBV

Arm C

EXPERIMENTAL

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks

Drug: DCV/ASV/BMS-791325 + RBV

Interventions

DCV/ASV/BMS-791325DRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day

Also known as: Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325
Arm 1Arm 2Arm 3
DCV/ASV/BMS-791325 + RBVDRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day

Arm AArm BArm C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects chronically infected with HCV genotype 1a
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)

You may not qualify if:

  • Evidence of cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to enrollment
  • Documented or suspected hepatocellular carcinoma (HCC)
  • Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

MeSH Terms

Conditions

Hepatitis CHepatitisHepatitis, ChronicHepatitis C, ChronicLiver DiseasesDigestive System DiseasesHepatitis, Viral, HumanRNA Virus Infections

Interventions

daclatasvirRibavirin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsVirus DiseasesFlaviviridae InfectionsChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Timothy R. Morgan, MD

    VA Long Beach Healthcare System/Southern California Institute for Research and Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief, Hepatology

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 28, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

US(1)