Safety and Efficacy Study in Subjects With Chronic HCV and Underlying Hemophilia

Hepatitis C Virus Clinical Trial

— MAGNITUDE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741545
• Other study ID #: AI452-030
• Secondary ID: 2012-003463-22
• Status: Completed
• Phase: Phase 3
• Start date: March 31, 2013
• Est. completion date: January 31, 2015

Study information

• Verified date: August 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 31, 2015
• Est. primary completion date: January 31, 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

Biological:
• Pegylated-Interferon-lambda

Drug:
• Ribavirin

• Daclatasvir

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Herston	Queensland
Australia	Local Institution	Herston
Australia	Local Institution	Melbourne	Victoria
France	Local Institution	Grenoble
France	Local Institution	Lyon Cedex 04
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Paris Cedex 13
France	Local Institution	Paris Cedex 14
France	Local Institution	Vandoeuvre Les Nancy
Italy	Local Institution	Firenze
Italy	Local Institution	Milan
Italy	Local Institution	Roma
Italy	Local Institution	Torino
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Nijmegen
Netherlands	Local Institution	Rotterdam
Netherlands	Local Institution	Utrecht
Romania	Local Institution	Bucuresti
Romania	Local Institution	Constanta
Romania	Local Institution	Iasi
Romania	Local Institution	Iasi
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Saint Petersburg
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Sevilla
United States	Rush University Medical Center	Chicago	Illinois
United States	Clinical Research Centers Of America	Murray	Utah
United States	Stanford Boswell Clinic	Palo Alto	California
United States	Hospital Of The University Of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  France,  Italy,  Netherlands,  Romania,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved Sustained Virologic Response (SVR12) at Follow-Up Week 12	SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.	Follow-up Week 12
Secondary	Percentage of Participants With Rapid Virologic Response (RVR)	RVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 4.	Treatment Week 4
Secondary	Percentage of Participants With Complete Early Virologic Response (cEVR)	cEVR was defined as HCV RNA less than the lower limit of quantitation, target not detected at Week 12.	Treatment Week 12
Secondary	Percentage of Participants With End of the Treatment Response (EOTR)	EOTR was defined as HCV RNA less than the lower limit of quantitation, target not detected at end of treatment.	End of the treatment (Week 12 for Cohort A, Week 24 for Cohort B)
Secondary	Percentage of Participants With Sustained Virologic Response at Follow-Up Week 24 (SVR24)	SVR24 was defined as HCV RNA less than the lower limit of quantitation, target detected or target not detected at follow-up week 24.	Follow-up Week 24
Secondary	Percentage of Participants With Treatment-Emergent Cytopenic Abnormalities On-Treatment	Cytopenic abnormalities were defined as anemia: Hemoglobin (Hb) <10 g/dL, and/or neutropenia: absolute neutrophils and bands (ANC) <750 mm^3, and/or thrombocytopenia: platelets <50,000 mm^3.	After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Secondary	Percentage of Participants With Flu-Like Symptoms and Musculoskeletal Symptoms On-Treatment	Flu-like symptoms were defined as pyrexia or chills or pain. Musculoskeletal symptoms were defined as arthralgia or myalgia or back pain.	After day 1 to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)
Secondary	Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Dose Reductions, And Death	AE=any new untoward medical event or worsening of a preexisting medical condition that does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related SAE=possibly, probably, or certainly related to study drug.	From Day 1 to end of follow-up (maximum of 60 weeks for Cohort A and 72 weeks for Cohort B)
Secondary	Number of Participants With Treatment Emergent Grade 3 to 4 Laboratory Abnormalities	Laboratory abnormalities were determined and graded using the Division of acquired immunodeficiency syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, version 1.0. International Normalized Ratio (INR): >2.0*Upper limit of normal (ULN); Alanine aminotransferase (ALT) : >5*ULN; Aspartate aminotransferase (AST): >5*ULN; Prothrombin Time (PT): >1.50*ULN; Bilirubin (Total): >2.5*ULN; Triglycerides (fasting): >750 mg/dL.	After day 1 to to end of treatment (Up to 85 Days for Cohort A, Up to 168 Days for Cohort B)

External Links

•   BMS clinical trial educational resource
•   Investigator Inquiry form