The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - Part A PDR is defined as HCV RNA at Week 4 < LLOQ and Week 12 undetectable
Part B PDR is defined as HCV RNA at Week 2 = 2 log10 decrease (or < Lower limit of quantitation (LLOQ) if baseline HCV RNA < 2400 IU/mL), Week 4 < LLOQ and Week 12 undetectable
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/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
Other publications