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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01309932




Registration number
NCT01309932
Ethics application status
Date submitted
4/03/2011
Date registered
7/03/2011
Date last updated
9/10/2015

Titles & IDs
Public title
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
Scientific 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
Secondary ID [1] 0 0
2010-022568-11
Secondary ID [2] 0 0
AI452-008
Universal Trial Number (UTN)
Trial acronym
D-LITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Pegylated Interferon Lambda (pegIFN?)
Treatment: Drugs - BMS-790052 (NS5A Inhibitor)
Treatment: Drugs - Ribavirin (RBV)
Treatment: Drugs - BMS-650032 (NS3 Protease Inhibitor)
Other interventions - Pegylated Interferon Alfa-2a (pegIFNa-2a)
Other interventions - Pegylated Interferon Lambda (pegIFN?)
Treatment: Drugs - Ribavirin (RBV)
Other interventions - Pegylated Interferon Lambda (pegIFN?)
Treatment: Drugs - Ribavirin (RBV)
Treatment: Drugs - BMS-790052 (NS5A Inhibitor)
Treatment: Drugs - BMS-650032 (NS3 Protease Inhibitor)
Treatment: Drugs - Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
Treatment: Drugs - Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
Treatment: Drugs - Placebo for Ribavirin (RBV)
Treatment: Drugs - Placebo for Ribavirin (RBV)

Experimental: A1: pegIFN?+BMS-790052+Placebo for BMS-650032+Ribavirin - Part A

Experimental: A2: pegIFN?+BMS-650032+Placebo for BMS-790052+Ribavirin - Part A

Active Comparator: A3: pegIFNa-2a+PBO for BMS-790052+PBO for BMS-650032+RBV - Part A

Experimental: A4: pegIFN?+BMS-790052+BMS-650032+Ribavirin (24 weeks) - Part B

Experimental: A5: pegIFN?+BMS-790052+BMS-650032+Ribavirin (16 weeks) - Part B

Experimental: A6: pegIFN?+BMS-790052+BMS-650032+Placebo for RBV (24 weeks) - Part B

Experimental: A7: pegIFN?+BMS-790052+BMS-650032+Placebo for RBV (16 weeks) - Part B


Other interventions: Pegylated Interferon Lambda (pegIFN?)
Solution, Subcutaneous, 180 µg/mL, Once weekly, 24 or 48 weeks depending on response

Treatment: Drugs: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 24 weeks

Treatment: Drugs: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

Treatment: Drugs: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 24 weeks

Other interventions: Pegylated Interferon Alfa-2a (pegIFNa-2a)
Solution, Subcutaneous, 180 µg/mL, Once weekly, 48 weeks

Other interventions: Pegylated Interferon Lambda (pegIFN?)
Solution, Subcutaneous, 180 µg/mL, Once weekly, 24 weeks

Treatment: Drugs: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks

Other interventions: Pegylated Interferon Lambda (pegIFN?)
Solution, Subcutaneous, 180 µg/mL, Once weekly, 16 weeks

Treatment: Drugs: Ribavirin (RBV)
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks

Treatment: Drugs: BMS-790052 (NS5A Inhibitor)
Tablets, Oral, 60 mg, Once daily, 16 weeks

Treatment: Drugs: BMS-650032 (NS3 Protease Inhibitor)
Tablets, Oral, 200 mg, Twice daily, 16 weeks

Treatment: Drugs: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
Tablets, Oral, 0 mg, Twice daily, 24 weeks

Treatment: Drugs: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
Tablets, Oral, 0 mg, Once daily, 24 weeks

Treatment: Drugs: Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 24 weeks

Treatment: Drugs: Placebo for Ribavirin (RBV)
Tablets, Oral, 0 mg, Twice daily, 16 weeks
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs)
Timepoint [1] 0 0
Up to end of treatment ( maximum of 48 weeks) plus 30 days
Primary outcome [2] 0 0
Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)
Timepoint [2] 0 0
At end of treatment (maximum of 48 weeks)
Primary outcome [3] 0 0
Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)
Timepoint [3] 0 0
Post-treatment Week 24
Secondary outcome [1] 0 0
Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) for Part A and Part B
Timepoint [1] 0 0
Weeks 4, Weeks 12 and post-treatment Weeks 24
Secondary outcome [2] 0 0
Proportion of subjects with either a 2-log or greater decrease in Hepatitis C virus (HCV) Ribonucleic acid (RNA) levels from baseline or undetectable levels of HCV RNA
Timepoint [2] 0 0
Weeks 2, Weeks 4 and Weeks 12
Secondary outcome [3] 0 0
Proportion of subjects with viral breakthrough, defined as confirmed > 1 log10 increase in HCV RNA over nadir or confirmed HCV RNA = Lower limit of quantitation (LLOQ) after confirmed undetectable HCV RNA while on treatment
Timepoint [3] 0 0
Post-treatment Week 48
Secondary outcome [4] 0 0
Proportion of subjects with undetectable HCV RNA at the end of treatment that develop detectable levels of HCV RNA in the post-treatment follow-up period
Timepoint [4] 0 0
Post-treatment Week 48
Secondary outcome [5] 0 0
Serum HCV Ribonucleic acid (RNA) levels over time
Timepoint [5] 0 0
Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)
Secondary outcome [6] 0 0
Proportion of subjects with undetectable HCV RNA over time
Timepoint [6] 0 0
Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)
Secondary outcome [7] 0 0
Time to viral clearance, defined as an absence of detectable HCV RNA
Timepoint [7] 0 0
Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56
Secondary outcome [8] 0 0
Serum levels of pegIFN? and pegIFNa-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Maximum observed serum/plasma concentration (Cmax)
Timepoint [8] 0 0
Cmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFN? and pegIFNa-2a)
Secondary outcome [9] 0 0
Serum levels of pegIFN? and pegIFNa-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Time to maximum concentration (Tmax)
Timepoint [9] 0 0
Tmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFN? and pegIFNa-2a)
Secondary outcome [10] 0 0
Serum levels of pegIFN? and pegIFNa-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Minimal observed serum/plasma concentration (Cmin)
Timepoint [10] 0 0
Cmin will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFN? and pegIFNa-2a)
Secondary outcome [11] 0 0
Serum levels of pegIFN? and pegIFNa-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Area under the serum/plasma concentration-time curve during one dose interval AUC(TAU)
Timepoint [11] 0 0
AUC(TAU) will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFN? and pegIFNa-2a)
Secondary outcome [12] 0 0
Serum levels of pegIFN? and pegIFNa-2a and plasma levels of BMS-790052 and BMS-650032: In all subjects, trough concentrations will be assessed (Ctrough)
Timepoint [12] 0 0
Troughs at baseline (week 0), weeks 2, 4, 8, 12, 16, and 24
Secondary outcome [13] 0 0
Proportion of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA
Timepoint [13] 0 0
At end of treatment (maximum of 48 weeks) and follow-up Week 12
Secondary outcome [14] 0 0
Proportion of subjects with 4-week sustained virologic response (SVR4), defined as undetectable HCV RNA
Timepoint [14] 0 0
At end of treatment (maximum of 48 weeks) and follow-up Week 4

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com.



- 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%
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Adelaide
Recruitment hospital [2] 0 0
Local Institution - Clayton Vic
Recruitment hospital [3] 0 0
Local Institution - Heidelberg
Recruitment hospital [4] 0 0
Local Institution - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3168 - Clayton Vic
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Virginia
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
France
State/province [12] 0 0
Clichy Cedex
Country [13] 0 0
France
State/province [13] 0 0
Creteil
Country [14] 0 0
France
State/province [14] 0 0
Montpellier Cedex 5
Country [15] 0 0
France
State/province [15] 0 0
Nice Cedex 03
Country [16] 0 0
France
State/province [16] 0 0
Paris Cedex 12
Country [17] 0 0
France
State/province [17] 0 0
Paris Cedex 14
Country [18] 0 0
Germany
State/province [18] 0 0
Essen
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt
Country [20] 0 0
Germany
State/province [20] 0 0
Hamburg
Country [21] 0 0
Italy
State/province [21] 0 0
Pisa
Country [22] 0 0
Italy
State/province [22] 0 0
Roma
Country [23] 0 0
Japan
State/province [23] 0 0
Hiroshima
Country [24] 0 0
Japan
State/province [24] 0 0
Hokkaido
Country [25] 0 0
Japan
State/province [25] 0 0
Kanagawa
Country [26] 0 0
Japan
State/province [26] 0 0
Osaka
Country [27] 0 0
Japan
State/province [27] 0 0
Saitama
Country [28] 0 0
Japan
State/province [28] 0 0
Tokyo
Country [29] 0 0
New Zealand
State/province [29] 0 0
Auckland
Country [30] 0 0
New Zealand
State/province [30] 0 0
Christchurch
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
San Juan
Country [32] 0 0
Spain
State/province [32] 0 0
Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if combination therapy with Pegylated Interferon
Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or
BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC)
compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48
weeks.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01309932
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01309932