A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
NCT ID: NCT02496078
Last Updated: 2017-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2015-08-31
2017-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial
NCT01492504
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
NCT02170727
Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C
NCT02250001
Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual
NCT01995266
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
NCT02551861
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active dual arm
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
Daclatasvir tablet 60mg
Asunaprevir
Asunaprevir soft capsule 100 mg
Placebo arm
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
Daclatasvir
Daclatasvir tablet 60mg
Asunaprevir
Asunaprevir soft capsule 100 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Daclatasvir
Daclatasvir tablet 60mg
Asunaprevir
Asunaprevir soft capsule 100 mg
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bristol-Myers Squibb
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Beijing, Beijing Municipality, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Shijiazhuang, Hebei, China
Local Institution
Changsha, Hunan, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Nanjing, Jiangsu, China
Local Institution
Zhenjiang, Jiangsu, China
Local Institution
Changchun, Jilin, China
Local Institution
Shenyang, Liaoning, China
Local Institution
Shenyang, Liaoning, China
Local Institution
Qingdao, Shandong, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Xi’an, Shanxi, China
Local Institution
Xi’an, Shanxi, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Beijing, , China
Local Institution
Moscow, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Saint Petersburg, , Russia
Local Institution
Busan, , South Korea
Local Institution
Seoul, , South Korea
Local Institution
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AI447-114
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.