Clinical trial NCT01741545: Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-12-05
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12
timeFrame: Follow-up Week 12
Secondary outcomes:
measure: Percentage of Participants With Rapid Virologic Response (RVR)
timeFrame: Treatment Week 4
measure: Percentage of Participants With Complete Early Virologic Response (cEVR)
timeFrame: Treatment Week 12
measure: Percentage of Participants With End of the Treatment Response (EOTR)
timeFrame: End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)
measure: Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)
timeFrame: Follow-up Week 24
measure: Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment
timeFrame: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
measure: Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment
timeFrame: After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death
timeFrame: From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
measure: Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities
timeFrame: After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Boswell Clinic
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Philadelphia
country: United States
facility: Hospital Of The University Of Pennsylvania
state: Pennsylvania
city: Murray
country: United States
facility: Clinical Research Centers Of America
state: Utah
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Herston
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Herston
country: Australia
facility: Local Institution
city: Grenoble
country: France
facility: Local Institution
city: Lyon Cedex 04
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Firenze
country: Italy
facility: Local Institution
city: Milan
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Nijmegen
country: Netherlands
facility: Local Institution
city: Rotterdam
country: Netherlands
facility: Local Institution
city: Utrecht
country: Netherlands
facility: Local Institution
city: Bucuresti
country: Romania
facility: Local Institution
city: Constanta
country: Romania
facility: Local Institution
city: Iasi
country: Romania
facility: Local Institution
city: Iasi
country: Romania
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: