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

NCT ID: NCT01700179

Last Updated: 2023-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-09-30

Brief Summary

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.

Detailed 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.

Conditions

Chronic Hepatitis C Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACH-0143102 plus ribavirin daily

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.

Group Type: EXPERIMENTAL

ACH-0143102

Intervention Type: DRUG

Ribavirin

Intervention Type: DRUG

Interventions

ACH-0143102

Intervention Type: DRUG

Ribavirin

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Achillion, a wholly owned subsidiary of Alexion

INDUSTRY

Sponsor Role: collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ACH102-005

Identifier Type: -

Identifier Source: org_study_id