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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496078
• Other study ID #: AI447-114
• Status: Completed
• Phase: Phase 3
• First received: July 9, 2015
• Last updated: April 17, 2017
• Start date: August 2015
• Est. completion date: February 2017

Study information

• Verified date: September 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 2017
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Daclatasvir
Daclatasvir tablet 60mg
• Asunaprevir
Asunaprevir soft capsule 100 mg

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution	Changsha	Hunan
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Qingdao	Shandong
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shenyang	Liaoning
China	Local Institution	Shenyang	Liaoning
China	Local Institution	Shi Jia Zhuang	Hebei
China	Local Institution	Xi'an	Shanxi
China	Local Institution	Xi'an	Shanxi
China	Local Institution	Zhenjiang	Jiangsu
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St.petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

China,  Korea, Republic of,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-treatment Week 12
Secondary	Proportion of subjects with anemia on active Dual therapy		Post-treatment Week 12
Secondary	Proportion of subjects with neutropenia on active Dual therapy		Post-treatment Week 12
Secondary	Proportion of subjects with thrombocytopenia on active Dual therapy		Post-treatment Week 12
Secondary	On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)		Post-treatment week 12
Secondary	Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)		first 12 weeks on treatment
Secondary	Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)		first 12 weeks on treatment
Secondary	Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort		Post-treatment visit week 12
Secondary	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		post-treatment visit Week 24
Secondary	Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy		post-treatment visit Week 24
Secondary	Proportion of treated subjects with SVR12 for subjects randomized to placebo		Post-treatment visit week 12

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form