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

NCT02496078 | Completed Phase 3

• 1 other identifier: AI447-114
• Study Type: interventional
• Target: 207
• Locations: 3 countries
• Sites: 29

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Proportion of subjects with anemia on active Dual therapy

  Post-treatment Week 12

• Proportion of subjects with neutropenia on active Dual therapy

  Post-treatment Week 12

• Proportion of subjects with thrombocytopenia on active Dual therapy

  Post-treatment Week 12

• On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

  Post-treatment week 12

• Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)

  first 12 weeks on treatment

Study Arms (2)

Active dual arm

ACTIVE COMPARATOR

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; Drug: Asunaprevir

Placebo arm

PLACEBO COMPARATOR

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; Drug: Asunaprevir

Interventions

Daclatasvir DRUG

Daclatasvir tablet 60mg

Active dual arm; Placebo arm

Asunaprevir DRUG

Asunaprevir soft capsule 100 mg

Active dual arm; Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (29)

Local Institution

Beijing, Beijing Municipality, 100015, China

Location

Local Institution

Beijing, Beijing Municipality, 100034, China

Location

Local Institution

Beijing, Beijing Municipality, 100050, China

Location

Local Institution

Beijing, Beijing Municipality, 100054, China

Location

Local Institution

Guangzhou, Guangdong, 510060, China

Location

Local Institution

Guangzhou, Guangdong, 510515, China

Location

Local Institution

Shijiazhuang, Hebei, 050051, China

Location

Local Institution

Changsha, Hunan, 410008, China

Location

Local Institution

Nanjing, Jiangsu, 210002, China

Location

Local Institution

Nanjing, Jiangsu, 210003, China

Location

Local Institution

Nanjing, Jiangsu, 210029, China

Location

Local Institution

Zhenjiang, Jiangsu, 212000, China

Location

Local Institution

Changchun, Jilin, 130021, China

Location

Local Institution

Shenyang, Liaoning, 110002, China

Location

Local Institution

Shenyang, Liaoning, 110006, China

Location

Local Institution

Qingdao, Shandong, 266011, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200062, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200083, China

Location

Local Institution

Xi’an, Shanxi, 710038, China

Location

Local Institution

Xi’an, Shanxi, 710061, China

Location

Local Institution

Chengdu, Sichuan, 610041, China

Location

Local Institution

Beijing, 100039, China

Location

Local Institution

Moscow, 127015, Russia

Location

Local Institution

Saint Petersburg, 190103, Russia

Location

Local Institution

Saint Petersburg, 191167, Russia

Location

Local Institution

Busan, 47392, South Korea

Location

Local Institution

Seoul, 07061, South Korea

Location

Local Institution

Seoul, 08308, South Korea

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvir; asunaprevir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 14, 2015
• Study Start: August 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: February 1, 2017
• Last Updated: April 19, 2017

Record last verified: 2016-09

Locations

KR (3); CN (23); RU (3)