Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

Hepatitis C Infection Clinical Trial

Official title:

A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874770
• Other study ID #: AI444-014
• Secondary ID: EUDRACT# 2009-01
• Status: Completed
• Phase: Phase 2
• First received: April 2, 2009
• Last updated: September 23, 2015
• Start date: June 2009
• Est. completion date: January 2011

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaFrance: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to identify 1 or more doses of daclatasvir, which when used in combination with pegylated interferon alpha and ribavirin, are safe and demonstrate sufficient anti-hepatitis C virus activity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2011
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• Patients chronically infected with hepatitis C virus (HCV) genotype 1

• HCV RNA viral load of =10*5* IU/mL (100,000 IU/mL) at screening

• Treatment naive

Key Exclusion Criteria:

• Women of child-bearing potential

• Cirrhosis

• Coinfection with HIV or hepatitis B virus

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C Infection

Intervention

Drug:
• Daclatasvir
Tablets, oral, 3 mg, Daily, 48 weeks
• Daclatasvir
Tablets, oral, 10 mg, Daily, 48 weeks
• Daclatasvir
Tablets, oral, 60 mg, Daily, 48 weeks
• Placebo
Tablet, oral, 0 mg, Daily 48 weeks
• Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
• ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks

Locations

Country	Name	City	State
France	Local Institution	Creteil
France	Local Institution	Paris Cedex 14
France	Local Institution	Vandoeuvre Les Nancy
United States	North Texas Research Institute	Arlington	Texas
United States	University Of Colorado Denver & Hospital	Aurora	Colorado
United States	Mercy Medical Center	Baltimore	Maryland
United States	Veterans Affairs Medical Center	Bronx	New York
United States	Metropolitan Research	Fairfax	Virginia
United States	Alabama Liver & Digestive Specialists (Alds)	Montgomery	Alabama
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Llc Dba The Research Institute	Springfield	Massachusetts
United States	Carolinas Center For Liver Disease	Statesville	North Carolina
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Options Health Research, Llc	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase	An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.	SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drug	Yes
Other	Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period	An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.	From Day 31 up to Week 24 of post treatment follow-up	Yes
Other	Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results	Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as >5.0 to 10.0* Upper Limit of Normal (ULN), Grade 4 as >10.0*ULN; Aspartate aminotransferase (AST)- Grade 3 as >5.0 to 10.0*ULN, Grade 4 as >10.0*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as <7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749*10^9/L, Grade 4 as <0.5*10^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499*10^9/L, Grade 4 as <0.35*10^9/L; Total Bilirubin- Grade 3 as 2.6-5.0*ULN, Grade 4 as >5.0*ULN; Platelets- Grade 3 as 25000 to 49999*10^9/L, Grade 4 as <25000 10^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499*10^9/L, Grade 4 as <1000*10^9/L.	From screening up to Week 12 (treatment period)	Yes
Primary	Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12	eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.	A Weeks 4 and 12	Yes
Secondary	Percentage of Participants With Rapid Virologic Response (RVR) at Week 4	RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.	At Week 4	No
Secondary	Percentage of Participants With Early Virologic Response (EVR) at Week 12	EVR was defined as a =2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA <10 IU/mL for participants with baseline HCV RNA <1000 IU/mL.	At Week 12	No
Secondary	Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12	cEVR was defined as hepatitis C virus RNA <10 IU/mL at Week 12	At Week 12	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form