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

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ClinicalTrials.gov Identifier: NCT02496078
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Daclatasvir Drug: Asunaprevir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Arm Intervention/treatment
Active Comparator: 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

Drug: Daclatasvir
Daclatasvir tablet 60mg

Drug: Asunaprevir
Asunaprevir soft capsule 100 mg

Placebo Comparator: 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

Drug: Daclatasvir
Daclatasvir tablet 60mg

Drug: Asunaprevir
Asunaprevir soft capsule 100 mg




Primary Outcome Measures :
  1. Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12) [ Time Frame: Post-treatment Week 12 ]
    HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12


Secondary Outcome Measures :
  1. Proportion of subjects with anemia on active Dual therapy [ Time Frame: Post-treatment Week 12 ]
  2. Proportion of subjects with neutropenia on active Dual therapy [ Time Frame: Post-treatment Week 12 ]
  3. Proportion of subjects with thrombocytopenia on active Dual therapy [ Time Frame: Post-treatment Week 12 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Proportion of treated subjects with SVR12 for subjects randomized to placebo [ Time Frame: Post-treatment visit week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496078


Locations
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China, Beijing
Local Institution
Beijing, Beijing, China, 100015
Local Institution
Beijing, Beijing, China, 100034
Local Institution
Beijing, Beijing, China, 100050
Local Institution
Beijing, Beijing, China, 100054
China, Guangdong
Local Institution
Guangzhou, Guangdong, China, 510060
Local Institution
Guangzhou, Guangdong, China, 510515
China, Hebei
Local Institution
Shi Jia Zhuang, Hebei, China, 050051
China, Hunan
Local Institution
Changsha, Hunan, China, 410008
China, Jiangsu
Local Institution
Nanjing, Jiangsu, China, 210002
Local Institution
Nanjing, Jiangsu, China, 210003
Local Institution
Nanjing, Jiangsu, China, 210029
Local Institution
Zhenjiang, Jiangsu, China, 212000
China, Jilin
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Shenyang, Liaoning, China, 110002
Local Institution
Shenyang, Liaoning, China, 110006
China, Shandong
Local Institution
Qingdao, Shandong, China, 266011
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200025
Local Institution
Shanghai, Shanghai, China, 200062
Local Institution
Shanghai, Shanghai, China, 200083
China, Shanxi
Local Institution
Xi'an, Shanxi, China, 710038
Local Institution
Xi'an, Shanxi, China, 710061
China, Sichuan
Local Institution
Chengdu, Sichuan, China, 610041
China
Local Institution
Beijing, China, 100039
Korea, Republic of
Local Institution
Busan, Korea, Republic of, 47392
Local Institution
Seoul, Korea, Republic of, 07061
Local Institution
Seoul, Korea, Republic of, 08308
Russian Federation
Local Institution
Moscow, Russian Federation, 127015
Local Institution
St. Petersburg, Russian Federation, 191167
Local Institution
St.petersburg, Russian Federation, 190103
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02496078    
Other Study ID Numbers: AI447-114
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: September 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Asunaprevir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action