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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
State/province [55] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01616524