UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: Asunaprevir; Other: Placebo for DCV 3DAA; Other: Placebo for Asunaprevir; Drug: Daclatasvir; Drug: DCV 3DAA; Other: Placebo for Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02123654

AI443-117

Details and patient eligibility

About

The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).

Full description

Limit of Quantitation (LOQ)

Ribonucleic acid (RNA)

End of Treatment (EOT)

Triple Direct Acting Antivirals (3DAA)

Enrollment: 297 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• Males and females, ≥ 20 years of age
• Subjects chronically infected with HCV GT-1
• HCV RNA viral load of ≥ 100,000 IU/mL

Exclusion Criteria:

• Hepatocellular carcinoma
• Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
• Severe or uncontrollable complication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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297 participants in 3 patient groups

Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV

Experimental group

Description:

DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)

Treatment:

Other: Placebo for Asunaprevir

Drug: DCV 3DAA

Other: Placebo for Daclatasvir

Arm 2: DCV/ASV + Placebo for DCV 3DAA

Active Comparator group

Description:

Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)

Treatment:

Other: Placebo for DCV 3DAA

Drug: Asunaprevir

Drug: Daclatasvir

DCV 3DAA

Experimental group

Description:

DCV 3DAA (open label) Tablet orally twice daily for 12 weeks

Treatment:

Drug: DCV 3DAA