Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

Chronic Hepatitis C Clinical Trial

Official title:

Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012895
• Other study ID #: AI447-011
• Secondary ID: 2010-024637-23
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2009
• Last updated: September 23, 2015
• Start date: December 2009
• Est. completion date: February 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardEuropean Union: European Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: February 2014
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male and female subjects ages 18 to 70 years

• HCV-Infected Genotype 1 Null responders to current standard of care

• Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

Exclusion Criteria:

• Evidence of a medical condition associate with chronic liver disease other than HCV

• History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis

• History of Cancer within 5 years of enrollment

• History of gastrointestinal disease or surgical procedure (except Cholecystectomy)

• History of clinically significant cardiac disease

• History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Documented cirrhosis within 12 months prior to dosing

• Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)

• Pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
• BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
• BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
• BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
• Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
• Ribavirin
Tablets, Oral For subjects weighing < 75 kg: 1000 mg; For subjects weighing = 75 kg: 1200 mg Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); = 75 kg: 600 mg in AM and PM), 24 weeks

Locations

Country	Name	City	State
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil Cedex
France	Local Institution	Marseille Cedex 08
France	Local Institution	Paris Cedex 12
France	Local Institution	Paris Cedex 13
France	Local Institution	Paris Cedex 14
France	Local Institution	Pessac
Puerto Rico	Local Institution	San Juan
United States	Advanced Clinical Research Institute	Anaheim	California
United States	University Of Michigan Health System	Ann Arbor	Michigan
United States	Texas Clinical Research Institute, Llc	Arlington	Texas
United States	University Of Colorado Denver & Hospital	Aurora	Colorado
United States	Mercy Medical Center	Baltimore	Maryland
United States	Southern California Liver Centers	Coronado	California
United States	Metropolitan Research	Fairfax	Virginia
United States	Alamo Medical Research	San Antonio	Texas
United States	San Jose Gastroenterology	San Jose	California
United States	Carolinas Center For Liver Disease	Statesville	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment		12 weeks post treatment	No
Secondary	Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results	Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)	12 weeks post-treatment	Yes
Secondary	Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.		Day 1 and Day 14	Yes
Secondary	Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.		Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16	Yes
Secondary	Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.		Day 1 and Day 14	Yes
Secondary	Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.		Day 1 and Day 14	Yes

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form