Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

Hepatitis C Clinical Trial

Official title:

A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448044
• Other study ID #: AI444-042
• Secondary ID: 2011-002793-23
• Status: Completed
• Phase: Phase 3
• First received: October 5, 2011
• Last updated: September 11, 2015
• Start date: December 2011
• Est. completion date: January 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 Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: January 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants chronically infected with HCV Genotype 4

• HCV RNA viral load of = 10,000 IU/mL

• No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent

• Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted

Exclusion Criteria:

• Evidence of decompensated liver disease

• Documented or suspected Hepatocellular carcinoma (HCC)

• Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• BMS-790052 (NS5A Replication Complex Inhibitor)

• Placebo matching BMS-790052

• Pegylated-interferon alfa 2a

• Ribavirin

Locations

Country	Name	City	State
France	Local Institution	Bondy Cedex
France	Local Institution	Creteil
France	Local Institution	La Roche-Sur-Yon Cedex 9
France	Local Institution	Marseille Cedex 08
France	Local Institution	Nice Cedex 03
France	Local Institution	Orleans Cedex 2
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Strasbourg Cedex
France	Local Institution	Toulouse Cedex 09
France	Local Institution	Villejuif
Greece	Local Institution	Thesaloniki
Italy	Local Institution	Roma
Italy	Local Institution	Torino
Puerto Rico	Local Institution	San Juan
Spain	Local Institution	A Coruna
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United States	Metropolitan Research	Annandale	Virginia
United States	University Gastroenterology	Providence	Rhode Island
United States	Scti Research Foundation	San Clemente	California
United States	Umass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  France,  Greece,  Italy,  Puerto Rico,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)	Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.	Week 12 (Follow-up period)	No
Secondary	Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)	Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.	Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48	No
Secondary	Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels	Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.	Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48	No
Secondary	Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene	Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.	Post Treatment Weeks 12, 24	No
Secondary	Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died	AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.	From Day 1 (start of study treatment) up to Follow-up Week 4	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