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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01616524




Registration number
NCT01616524
Ethics application status
Date submitted
7/06/2012
Date registered
11/06/2012
Date last updated
9/10/2015

Titles & IDs
Public title
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
Scientific title
A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects
Secondary ID [1] 0 0
2011-004885-14
Secondary ID [2] 0 0
AI452-017
Universal Trial Number (UTN)
Trial acronym
PRINCIPAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus (HCV) 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
Treatment: Other - Pegylated interferon lambda (pegIFN?)
Treatment: Other - Pegylated interferon lambda (pegIFN?)
Treatment: Other - Pegylated interferon alfa-2a (pegIFNa-2a)
Treatment: Drugs - Ribavirin
Treatment: Drugs - Ribavirin
Treatment: Drugs - Daclatasvir
Treatment: Drugs - Placebo matching Daclatasvir

Experimental: Arm 1: pegIFN? + Ribavirin + Placebo matching Daclatasvir -

Experimental: Arm 2: pegIFN? + Ribavirin + Daclatasvir -

Experimental: Arm 3: pegIFNa-2a + Ribavirin + Placebo matching Daclatasvir -


Treatment: Other: Pegylated interferon lambda (pegIFN?)
Syringe, Subcutaneous, 180 µg, Once weekly, 24 weeks

Treatment: Other: Pegylated interferon lambda (pegIFN?)
Syringe, Subcutaneous, 180 µg, Once weekly, 12 weeks

Treatment: Other: Pegylated interferon alfa-2a (pegIFNa-2a)
Syringe, Subcutaneous, 180 µg, Once weekly, 24 weeks

Treatment: Drugs: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 24 weeks

Treatment: Drugs: Ribavirin
Tablets, Oral, 400 mg, Twice daily, 12 weeks

Treatment: Drugs: Daclatasvir
Tablets, Oral, 60 mg, Once daily, 12 weeks

Treatment: Drugs: Placebo matching Daclatasvir
Tablets, Oral, 0 mg, Once daily, 12 weeks
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)
Timepoint [1] 0 0
Post-treatment follow-up week 12
Secondary outcome [1] 0 0
Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]
Timepoint [1] 0 0
On-treatment Week 4
Secondary outcome [2] 0 0
Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)
Timepoint [2] 0 0
Up to week 12 or week 24
Secondary outcome [3] 0 0
Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)
Timepoint [3] 0 0
Up to week 12 or week 24
Secondary outcome [4] 0 0
Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
Timepoint [4] 0 0
Up to week 12 or week 24
Secondary outcome [5] 0 0
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group
Timepoint [5] 0 0
Post-treatment week 24
Secondary outcome [6] 0 0
Proportion of subjects with on-treatment Serious adverse events (SAEs)
Timepoint [6] 0 0
Up to week 12 or week 24
Secondary outcome [7] 0 0
Proportion of subjects with dose reductions
Timepoint [7] 0 0
Up to week 12 or week 24
Secondary outcome [8] 0 0
Proportion of subjects who discontinue due to Adverse events (AEs)
Timepoint [8] 0 0
Up to week 12 or week 24
Secondary outcome [9] 0 0
Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection
Timepoint [9] 0 0
Post-treatment follow-up week 12
Secondary outcome [10] 0 0
Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)
Timepoint [10] 0 0
Up to week 12 or week 24

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



* Chronic hepatitis C, Genotype 2 or 3
* Naïve to prior anti-HCV therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Infected with HCV other than Genotype 2 or 3
* Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
* Evidence of liver disease other than HCV
* Active substance abuse
* Evidence of decompensated cirrhosis

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 3
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
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
880
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Darlinghurst
Recruitment hospital [4] 0 0
Local Institution - Randwick
Recruitment hospital [5] 0 0
Local Institution - Westmead Nsw
Recruitment hospital [6] 0 0
Local Institution - Brisbane
Recruitment hospital [7] 0 0
Local Institution - Greenslopes
Recruitment hospital [8] 0 0
Local Institution - Herston
Recruitment hospital [9] 0 0
Local Institution - Adelaide
Recruitment hospital [10] 0 0
Local Institution - Clayton Vic
Recruitment hospital [11] 0 0
Local Institution - Fitzroy
Recruitment hospital [12] 0 0
Local Institution - Melbourne
Recruitment hospital [13] 0 0
Local Institution - Parville
Recruitment hospital [14] 0 0
Local Institution - Fremantle
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2031 - Randwick
Recruitment postcode(s) [5] 0 0
2145 - Westmead Nsw
Recruitment postcode(s) [6] 0 0
4102 - Brisbane
Recruitment postcode(s) [7] 0 0
4120 - Greenslopes
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3168 - Clayton Vic
Recruitment postcode(s) [11] 0 0
3065 VIC - Fitzroy
Recruitment postcode(s) [12] 0 0
3004 - Melbourne
Recruitment postcode(s) [13] 0 0
3050 - Parville
Recruitment postcode(s) [14] 0 0
6160 - Fremantle
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
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
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Oklahoma
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Santa Fe
Country [16] 0 0
Argentina
State/province [16] 0 0
Cordoba
Country [17] 0 0
Belgium
State/province [17] 0 0
Brussels
Country [18] 0 0
Belgium
State/province [18] 0 0
Leuven
Country [19] 0 0
Belgium
State/province [19] 0 0
Liege
Country [20] 0 0
Chile
State/province [20] 0 0
Metropolitana
Country [21] 0 0
Finland
State/province [21] 0 0
Hus
Country [22] 0 0
France
State/province [22] 0 0
Clichy Cedex
Country [23] 0 0
France
State/province [23] 0 0
Creteil Cedex
Country [24] 0 0
France
State/province [24] 0 0
Montpellier Cedex 5
Country [25] 0 0
France
State/province [25] 0 0
Nice Cedex 3
Country [26] 0 0
Greece
State/province [26] 0 0
Athens
Country [27] 0 0
Greece
State/province [27] 0 0
Thessaloniki
Country [28] 0 0
Hong Kong
State/province [28] 0 0
Hong Kong
Country [29] 0 0
Hong Kong
State/province [29] 0 0
Tai Po
Country [30] 0 0
Italy
State/province [30] 0 0
Firenze
Country [31] 0 0
Italy
State/province [31] 0 0
Milano
Country [32] 0 0
Italy
State/province [32] 0 0
Napoli
Country [33] 0 0
Italy
State/province [33] 0 0
Novara
Country [34] 0 0
Japan
State/province [34] 0 0
Fukuoka
Country [35] 0 0
Japan
State/province [35] 0 0
Hiroshima
Country [36] 0 0
Japan
State/province [36] 0 0
Hokkaido
Country [37] 0 0
Japan
State/province [37] 0 0
Hyogo
Country [38] 0 0
Japan
State/province [38] 0 0
Ibaraki
Country [39] 0 0
Japan
State/province [39] 0 0
Kagawa
Country [40] 0 0
Japan
State/province [40] 0 0
Kagoshima
Country [41] 0 0
Japan
State/province [41] 0 0
Kanagawa
Country [42] 0 0
Japan
State/province [42] 0 0
Okayama
Country [43] 0 0
Japan
State/province [43] 0 0
Saitama
Country [44] 0 0
Japan
State/province [44] 0 0
Tokyo
Country [45] 0 0
Japan
State/province [45] 0 0
Wakayama
Country [46] 0 0
Japan
State/province [46] 0 0
Miyazaki
Country [47] 0 0
Japan
State/province [47] 0 0
Saga
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Busan
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Daegu
Country [50] 0 0
Korea, Republic of
State/province [50] 0 0
Gyeonggi-do
Country [51] 0 0
Korea, Republic of
State/province [51] 0 0
Gyeongsangnam-do
Country [52] 0 0
Korea, Republic of
State/province [52] 0 0
Incheon
Country [53] 0 0
Korea, Republic of
State/province [53] 0 0
Seoul
Country [54] 0 0
Mexico
State/province [54] 0 0
Distrito Federal
Country [55] 0 0
Mexico
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Jalisco
Country [56] 0 0
Mexico
State/province [56] 0 0
Guadalajara
Country [57] 0 0
Mexico
State/province [57] 0 0
Mexico City
Country [58] 0 0
Netherlands
State/province [58] 0 0
Amsterdam
Country [59] 0 0
Netherlands
State/province [59] 0 0
Leiden
Country [60] 0 0
New Zealand
State/province [60] 0 0
Auckland
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Chelyabinsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Irkutsk
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Krasnoyarsk
Country [64] 0 0
Russian Federation
State/province [64] 0 0
Moscow
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Saint-Petersburg
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Samara
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Smolensk
Country [68] 0 0
Russian Federation
State/province [68] 0 0
St. Petersburg
Country [69] 0 0
Singapore
State/province [69] 0 0
Singapore
Country [70] 0 0
Taiwan
State/province [70] 0 0
Kaohsiung
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taichung
Country [72] 0 0
Taiwan
State/province [72] 0 0
Tainan
Country [73] 0 0
Taiwan
State/province [73] 0 0
Yunlin
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Humberside
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Nottinghamshire
Country [76] 0 0
United Kingdom
State/province [76] 0 0
West Midlands
Country [77] 0 0
United Kingdom
State/province [77] 0 0
London

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 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin
Trial website
https://clinicaltrials.gov/study/NCT01616524
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/study/NCT01616524