A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1 (UNITY 4)

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Hepatitis C Virus

Treatments

Drug: DCV/ASV/BMS-791325

Study type

Interventional

Funder types

Industry

Identifiers

NCT02170727

AI443-123

Details and patient eligibility

About

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

Full description

US National Institutes of Health Division of AIDs (DAIDS)

Enrollment

199 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

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

Exclusion Criteria:

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