D-LITE: Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT01795911

Collaborator

(none)

165

Enrollment

Location

Arm

Duration (Months)

9.1

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Biological: Pegylated Interferon Lambda Drug: Ribasphere Drug: Daclatasvir	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

165 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir 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 Lambda Other Names: BMS-914143 Drug: Ribasphere Other Names: Ribavirin Drug: Daclatasvir Other Names: BMS-790052

Arm

Intervention/Treatment

Experimental: Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir

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 Lambda

Other Names:

BMS-914143

Drug: Ribasphere

Other Names:

Ribavirin

Drug: Daclatasvir

Other Names:

BMS-790052

Outcome Measures

Primary Outcome Measures

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 [Post-treatment Week 12]
HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation

Secondary Outcome Measures

Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected [At Week 4 and Week 12]
eRVR = Extended rapid virologic response
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]
Hb = Hemoglobin; ANC = Absolute neutrophil count
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]
Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48]
Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48]
Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12]
Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12]
Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12]
Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12]
Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12]
Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks) [On-treatment Weeks 1, 2, 4, 8, and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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%

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alamo Medical Research	San Antonio	Texas	United States	78215

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT01795911

Other Study ID Numbers:

AI452-008 (Substudy Part C)
2010-022568-11

First Posted:

Feb 21, 2013

Last Update Posted:

Oct 9, 2015

Last Verified:

Sep 1, 2015

Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 9, 2015