Back to resultsSafety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin (D-LITE)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pegylated Interferon Lambda
Ribasphere
Daclatasvir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility Criteria
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
Sites / Locations
- Alamo Medical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir
Arm Description
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
Outcomes
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
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
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
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)
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)
Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected
Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)
Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)
Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)
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)
Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)
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)
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)
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)
Full Information
NCT ID
NCT01795911
First Posted
February 20, 2013
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01795911
Brief Title
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Acronym
D-LITE
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon Lambda
Other Intervention Name(s)
BMS-914143
Intervention Type
Drug
Intervention Name(s)
Ribasphere
Other Intervention Name(s)
Ribavirin
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052
Primary Outcome Measure Information:
Title
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
Description
HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation
Time Frame
Post-treatment Week 12
Secondary Outcome Measure Information:
Title
Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected
Description
eRVR = Extended rapid virologic response
Time Frame
At Week 4 and Week 12
Title
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
Description
Hb = Hemoglobin; ANC = Absolute neutrophil count
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
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)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
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)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected
Time Frame
Post-treatment follow-up Week 24
Title
Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48
Title
Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48
Title
Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
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)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
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)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
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)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
Title
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)
Time Frame
On-treatment Weeks 1, 2, 4, 8, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
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