Clinical trial NCT02496078: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-07-14
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)
timeFrame: Post-treatment Week 12
Secondary outcomes:
measure: Proportion of subjects with anemia on active Dual therapy
timeFrame: Post-treatment Week 12
measure: Proportion of subjects with neutropenia on active Dual therapy
timeFrame: Post-treatment Week 12
measure: Proportion of subjects with thrombocytopenia on active Dual therapy
timeFrame: Post-treatment Week 12
measure: On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
timeFrame: Post-treatment week 12
measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)
timeFrame: first 12 weeks on treatment
measure: Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)
timeFrame: first 12 weeks on treatment
measure: Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort
timeFrame: Post-treatment visit week 12
measure: 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
timeFrame: post-treatment visit Week 24
measure: Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy
timeFrame: post-treatment visit Week 24
measure: Proportion of treated subjects with SVR12 for subjects randomized to placebo
timeFrame: Post-treatment visit week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Beijing
country: China
facility: Local Institution
state: Beijing
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution
state: Guangdong
city: Shi Jia Zhuang
country: China
facility: Local Institution
state: Hebei
city: Changsha
country: China
facility: Local Institution
state: Hunan
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Nanjing
country: China
facility: Local Institution
state: Jiangsu
city: Zhenjiang
country: China
facility: Local Institution
state: Jiangsu
city: Changchun
country: China
facility: Local Institution
state: Jilin
city: Shenyang
country: China
facility: Local Institution
state: Liaoning
city: Shenyang
country: China
facility: Local Institution
state: Liaoning
city: Qingdao
country: China
facility: Local Institution
state: Shandong
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Shanghai
country: China
facility: Local Institution
state: Shanghai
city: Xi'an
country: China
facility: Local Institution
state: Shanxi
city: Xi'an
country: China
facility: Local Institution
state: Shanxi
city: Chengdu
country: China
facility: Local Institution
state: Sichuan
city: Beijing
country: China
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.petersburg
country: Russian Federation
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: