NCT01795911

Brief Summary

Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

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

February 20, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

October 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.1 years

First QC Date

February 20, 2013

Last Update Submit

September 23, 2015

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected

    HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation

    Post-treatment Week 12

Secondary Outcomes (13)

  • Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected

    At Week 4 and Week 12

  • Proportion of non-cirrhotic HCV GT-1b subjects with treatment-emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3, and/or thrombocytopenia as defined by platelets < 50,000 mm3) on treatment

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

  • Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or chills or pain)

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

  • Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain)

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

  • Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected

    Post-treatment follow-up Week 24

  • +8 more secondary outcomes

Study Arms (1)

Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir

EXPERIMENTAL

Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks; Ribasphere 1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day \[subjects should take either 400 mg for subjects \< 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food\] for 12 weeks; Daclatasvir 60 mg oral tablet Once daily for 12 weeks

Biological: Pegylated Interferon LambdaDrug: RibasphereDrug: Daclatasvir

Interventions

Pegylated Interferon LambdaBIOLOGICAL
Also known as: BMS-914143
Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir
RibasphereDRUG
Also known as: Ribavirin
Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir
DaclatasvirDRUG
Also known as: BMS-790052
Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Hepatitis C, Genotype 1
  • HCV RNA \>100,000 IU/mL at screening;
  • Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
  • Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

You may not qualify if:

  • Any evidence of liver disease other than HCV;
  • Co-infection with HIV;
  • Diagnosed or suspected hepatocellular carcinoma;
  • Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alamo Medical Research

San Antonio, Texas, 78215, United States

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Interventions

peginterferon lambda-1aRibavirindaclatasvir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

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

February 20, 2013

First Posted

February 21, 2013

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

September 1, 2014

Last Updated

October 9, 2015

Record last verified: 2015-09

Locations

US(1)