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A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daclatasvir
Asunaprevir
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Patients chronically infected with HCV Genotype 1b
  • No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent
  • HCV RNA viral load ≥ 10,000 IU/mL at screening
  • Seronegative for HIV and HBsAg
  • BMI of 18-35 kg/m2, inclusive
  • Patients with compensated cirrhosis are permitted

Exclusion Criteria:

  • Infection with HCV other than genotype (GT) -1b
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
  • Evidence of a medical condition contributing to chronic liver disease other than HCV
  • Diagnosed or suspected hepatocellular carcinoma or other malignancies
  • Uncontrolled diabetes or hypertension
  • History of moderate to severe depression. Well-controlled mild depression is allowed
  • Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN)
  • Confirmed platelet count < 50,000 cells/mm3
  • Confirmed hemoglobin < 8.5 g/dL

Sites / Locations

  • Local Institution
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  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active dual arm

Placebo arm

Arm Description

Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 24 week and follow up to week 48

Daclatasvir placebo in tablet form QD and Asunaprevir placebo in soft capsule form BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 36 week and follow up to week 60

Outcomes

Primary Outcome Measures

Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)
HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12

Secondary Outcome Measures

Proportion of subjects with anemia on active Dual therapy
Proportion of subjects with neutropenia on active Dual therapy
Proportion of subjects with thrombocytopenia on active Dual therapy
On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)
Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)
Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort
Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy
Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy
Proportion of treated subjects with SVR12 for subjects randomized to placebo

Full Information

First Posted
July 9, 2015
Last Updated
April 17, 2017
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02496078
Brief Title
A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Official Title
A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
February 2017 (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 determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active dual arm
Arm Type
Active Comparator
Arm Description
Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 24 week and follow up to week 48
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Daclatasvir placebo in tablet form QD and Asunaprevir placebo in soft capsule form BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 36 week and follow up to week 60
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Description
Daclatasvir tablet 60mg
Intervention Type
Drug
Intervention Name(s)
Asunaprevir
Intervention Description
Asunaprevir soft capsule 100 mg
Primary Outcome Measure Information:
Title
Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)
Description
HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12
Time Frame
Post-treatment Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects with anemia on active Dual therapy
Time Frame
Post-treatment Week 12
Title
Proportion of subjects with neutropenia on active Dual therapy
Time Frame
Post-treatment Week 12
Title
Proportion of subjects with thrombocytopenia on active Dual therapy
Time Frame
Post-treatment Week 12
Title
On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame
Post-treatment week 12
Title
Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)
Time Frame
first 12 weeks on treatment
Title
Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)
Time Frame
first 12 weeks on treatment
Title
Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort
Time Frame
Post-treatment visit week 12
Title
Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy
Time Frame
post-treatment visit Week 24
Title
Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy
Time Frame
post-treatment visit Week 24
Title
Proportion of treated subjects with SVR12 for subjects randomized to placebo
Time Frame
Post-treatment visit week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Patients chronically infected with HCV Genotype 1b No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent HCV RNA viral load ≥ 10,000 IU/mL at screening Seronegative for HIV and HBsAg BMI of 18-35 kg/m2, inclusive Patients with compensated cirrhosis are permitted Exclusion Criteria: Infection with HCV other than genotype (GT) -1b Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy Evidence of a medical condition contributing to chronic liver disease other than HCV Diagnosed or suspected hepatocellular carcinoma or other malignancies Uncontrolled diabetes or hypertension History of moderate to severe depression. Well-controlled mild depression is allowed Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN) Confirmed platelet count < 50,000 cells/mm3 Confirmed hemoglobin < 8.5 g/dL
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
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Local Institution
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100054
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Local Institution
City
Shi Jia Zhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
Local Institution
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Facility Name
Local Institution
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Local Institution
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Facility Name
Local Institution
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110002
Country
China
Facility Name
Local Institution
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110006
Country
China
Facility Name
Local Institution
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266011
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200062
Country
China
Facility Name
Local Institution
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200083
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710038
Country
China
Facility Name
Local Institution
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Local Institution
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
47392
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Facility Name
Local Institution
City
St.petersburg
ZIP/Postal Code
190103
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

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