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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01741545




Registration number
NCT01741545
Ethics application status
Date submitted
3/12/2012
Date registered
5/12/2012
Date last updated
11/08/2020

Titles & IDs
Public title
Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
Scientific title
A Phase 3 Study Evaluating the Safety and Efficacy of Lambda/Ribavirin/Daclatasvir in Subjects With Chronic HCV Infection and Underlying Hemophilia Who Are Treatment Naïve or Are Prior Relapsers to Peginterferon Alfa-2a/Ribavirin
Secondary ID [1] 0 0
2012-003463-22
Secondary ID [2] 0 0
AI452-030
Universal Trial Number (UTN)
Trial acronym
MAGNITUDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Virus 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
Experimental: Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) - Lambda 180 µg solution for subcutaneous (SC) injection, once weekly for 12 weeks

Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks

Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks

Experimental: Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV) - Lambda 180 µg solution for subcutaneous (SC) injection, once weekly for 24 weeks

Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks

Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
Timepoint [1] 0 0
Follow-up Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Rapid Virologic Response (RVR)
Timepoint [1] 0 0
Treatment Week 4
Secondary outcome [2] 0 0
Percentage of Participants With Complete Early Virologic Response (cEVR)
Timepoint [2] 0 0
Treatment Week 12
Secondary outcome [3] 0 0
Percentage of Participants With End of the Treatment Response (EOTR)
Timepoint [3] 0 0
End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)
Secondary outcome [4] 0 0
Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)
Timepoint [4] 0 0
Follow-up Week 24
Secondary outcome [5] 0 0
Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment
Timepoint [5] 0 0
After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Secondary outcome [6] 0 0
Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
Timepoint [6] 0 0
After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Secondary outcome [7] 0 0
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
Timepoint [7] 0 0
From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
Secondary outcome [8] 0 0
Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
Timepoint [8] 0 0
After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

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



* Severe hemophilia (defined as < 1% factor activity level)
* Infection with the hepatitis C virus (HCV) with underlying hemophilia
* Males 18 years of age and above
* Have not been previously treated with an interferon
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Not infected with the hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Chronic liver disease caused by any disease other than chronic HCV infection
* Presence of Bethesda inhibitor
* Current evidence of or history of portal hypertension

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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
31/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2015
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Herston
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Pennsylvania
Country [4] 0 0
United States of America
State/province [4] 0 0
Utah
Country [5] 0 0
France
State/province [5] 0 0
Grenoble
Country [6] 0 0
France
State/province [6] 0 0
Lyon Cedex 04
Country [7] 0 0
France
State/province [7] 0 0
Montpellier Cedex 5
Country [8] 0 0
France
State/province [8] 0 0
Paris Cedex 13
Country [9] 0 0
France
State/province [9] 0 0
Paris Cedex 14
Country [10] 0 0
France
State/province [10] 0 0
Vandoeuvre Les Nancy
Country [11] 0 0
Italy
State/province [11] 0 0
Firenze
Country [12] 0 0
Italy
State/province [12] 0 0
Milan
Country [13] 0 0
Italy
State/province [13] 0 0
Roma
Country [14] 0 0
Italy
State/province [14] 0 0
Torino
Country [15] 0 0
Netherlands
State/province [15] 0 0
Amsterdam
Country [16] 0 0
Netherlands
State/province [16] 0 0
Nijmegen
Country [17] 0 0
Netherlands
State/province [17] 0 0
Rotterdam
Country [18] 0 0
Netherlands
State/province [18] 0 0
Utrecht
Country [19] 0 0
Romania
State/province [19] 0 0
Bucuresti
Country [20] 0 0
Romania
State/province [20] 0 0
Constanta
Country [21] 0 0
Romania
State/province [21] 0 0
Iasi
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Moscow
Country [23] 0 0
Russian Federation
State/province [23] 0 0
Saint Petersburg
Country [24] 0 0
Spain
State/province [24] 0 0
Barcelona
Country [25] 0 0
Spain
State/province [25] 0 0
Madrid
Country [26] 0 0
Spain
State/province [26] 0 0
Sevilla

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

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective for this study is to evaluate the proportion of subjects who achieve SVR12 (HCV RNA \< LLOQ (target not detected) at post-treatment follow-up Week 12 in subjects with Genotype(GT)-1b, -4 and GT-2, -3
Trial website
https://clinicaltrials.gov/study/NCT01741545
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/NCT01741545