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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BMS-790052 (NS5A Replication Complex Inhibitor)
Placebo matching BMS-790052
Pegylated-interferon alfa 2a
Ribavirin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring hepatitis C virus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scti Research Foundation
  • Umass Memorial Medical Center
  • University Gastroenterology
  • Metropolitan Research
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

BMS-790052 + PegIFNα-2a + Ribavirin

Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin

Arm Description

BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response

Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
October 5, 2011
Last Updated
September 11, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01448044
Brief Title
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
hepatitis C virus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-790052 + PegIFNα-2a + Ribavirin
Arm Type
Experimental
Arm Description
BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response
Arm Title
Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin
Arm Type
Placebo Comparator
Arm Description
Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks Ribavirin 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-790052 (NS5A Replication Complex Inhibitor)
Intervention Type
Drug
Intervention Name(s)
Placebo matching BMS-790052
Intervention Type
Drug
Intervention Name(s)
Pegylated-interferon alfa 2a
Other Intervention Name(s)
Pegasys
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Primary Outcome Measure Information:
Title
Percentage of Participants With 12 Week Sustained Virologic Response (SVR12)
Description
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.
Time Frame
Week 12 (Follow-up period)
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ)
Description
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.
Time Frame
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
Title
Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels
Description
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.
Time Frame
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
Title
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
Description
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.
Time Frame
Post Treatment Weeks 12, 24
Title
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died
Description
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.
Time Frame
From Day 1 (start of study treatment) up to Follow-up Week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Scti Research Foundation
City
San Clemente
State/Province
California
ZIP/Postal Code
92673
Country
United States
Facility Name
Umass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Metropolitan Research
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Local Institution
City
Bondy Cedex
ZIP/Postal Code
93143
Country
France
Facility Name
Local Institution
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Local Institution
City
La Roche-Sur-Yon Cedex 9
ZIP/Postal Code
85925
Country
France
Facility Name
Local Institution
City
Marseille Cedex 08
ZIP/Postal Code
13285
Country
France
Facility Name
Local Institution
City
Nice Cedex 03
ZIP/Postal Code
06202
Country
France
Facility Name
Local Institution
City
Orleans Cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Local Institution
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 09
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Local Institution
City
Thesaloniki
ZIP/Postal Code
54639
Country
Greece
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
26313445
Citation
Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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