Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir; Drug: Daclatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02032901

AI444-218

Details and patient eligibility

About

To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Key Inclusion Criteria:

• Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
• Subjects chronically infected with hepatitis C virus (HCV) genotype 3
• Subjects who are HCV treatment-naive
• Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
• HCV RNA ≥10,000 IU/mL at screening

Key Exclusion Criteria:

• HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
• Liver or any other organ 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, 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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173 participants in 2 patient groups

A1:Daclatasvir + Sofosbuvir in treatment-naive subjects

Experimental group

Description:

Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks

Treatment:

Drug: Daclatasvir

Drug: Sofosbuvir

A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects

Experimental group

Description:

Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks

Treatment:

Drug: Daclatasvir

Drug: Sofosbuvir