Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: Ribavirin; Drug: ACH-0143102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01700179

ACH102-005

Details and patient eligibility

About

The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis C virus (HCV) participants.

Full description

A Phase 1b, pilot study that evaluated the safety, tolerability, and antiviral activity of oral ACH-0143102 administered in combination with ribavirin for 12 weeks in treatment-naive participants with chronic HCV GT1b.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged 18 years and older.
• Clinical diagnosis of hepatitis C with GT1b.
• Chronic hepatitis C treatment-naive participants.
• Interleukin 28B genotype CC.
• HCV ribonucleic acid > 10,000 international units/milliliter at screening.
• Female participants must be willing to use 2 effective methods of contraception during the dosing period and for 6 months after the last dose of ribavirin.
• Male participants must be willing to use an effective barrier method of contraception throughout the dosing period and for 6 months after the last dose of ribavirin. Male participants must agree not to donate sperm while enrolled in the study and for 6 months after the last dose of ribavirin.
• Willing to participate in all study activities and all study requirements.

Exclusion criteria

• Body mass index > 36 kilograms/meter squared.
• Pregnant or nursing females.
• Clinically significant laboratory abnormalities at screening.
• Previous participation in a clinical trial with protease inhibitor and/or non-structural protein 5A inhibitor.
• Human immunodeficiency virus infection or other liver diseases.
• Positive hepatitis B surface antigen.
• Liver cirrhosis.
• Uncontrolled psychiatric disease.
• Clinical evidence of chronic cardiac disease.
• History of malignancy of any organ system within 5 years.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

ACH-0143102 plus ribavirin daily

Experimental group

Description:

ACH-0143102 loading dose (225 milligrams \[mg\]) on Day 1, followed by maintenance doses (75 mg) on Days 2-84, plus weight-based ribavirin as per label on Days 1-84.

Treatment:

Drug: Ribavirin

Drug: ACH-0143102