A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

NCT02170727 | Completed Phase 3 Results

• 1 other identifier: AI443-123
• Study Type: interventional
• Target: 199
• Locations: 3 countries
• Sites: 20

Brief Summary

To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort

  Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA \< LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.

  Post treatment Week 12

Secondary Outcomes (11)

• Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort

  Post treatment Week 12

• Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND

  On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)

• Percentage of Participants Who Achieved HCV RNA < LLOQ TND

  On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)

• Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment

  Up to post treatment week 4

• Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline

  Up to post treatment week 4

Study Arms (1)

Arm 1 : DCV/ASV/BMS-791325

EXPERIMENTAL

DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks

Drug: DCV/ASV/BMS-791325

Interventions

DCV/ASV/BMS-791325 DRUG

Arm 1 : DCV/ASV/BMS-791325

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject chronically infected with HCV genotype 1 (GT-1)
• Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
• HCV RNA ≥ 10,000 IU/mL at screening
• Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
• Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV

You may not qualify if:

• Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
• Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
• Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
• Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (20)

Local Institution

Kazan', 420140, Russia

Location

Local Institution

Moscow, 109240, Russia

Location

Local Institution

Busan, 602-739, South Korea

Location

Local Institution

Busan, 614-735, South Korea

Location

Local Institution

Gyeonggi-do, 463-707, South Korea

Location

Local Institution

Gyeonggi-do, 480-717, South Korea

Location

Local Institution

Gyeongsangnam-do, 626-770, South Korea

Location

Local Institution

Inchoen, 405-760, South Korea

Location

Local Institution

Seoul, 120-752, South Korea

Location

Local Institution

Seoul, 135-710, South Korea

Location

Local Institution

Seoul, 138-736, South Korea

Location

Local Institution

Seoul, 156-755, South Korea

Location

Local Institution

Kaohsiung City, 807, Taiwan

Location

Local Institution

Kaohsiung City, 833, Taiwan

Location

Local Institution

Taichung, 40447, Taiwan

Location

Local Institution

Taichung, 40705, Taiwan

Location

Local Institution

Tainan, 704, Taiwan

Location

Local Institution

Taipei, 100, Taiwan

Location

Local Institution

Taipei, 112, Taiwan

Location

Local Institution

Taoyuan District, 333, Taiwan

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Hepatitis C

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

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: June 26, 2014
• Primary Completion: June 12, 2015
• Study Completion: September 9, 2015
• Last Updated: October 29, 2020
• Results First Posted: August 16, 2019

Record last verified: 2020-10

Locations

TW (8); RU (2); KR (10)