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

Phase 1

Completed

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: ACH-0143102; Drug: Ribavirin

• Registration Number: NCT01700179
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-02
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Results First Submitted: 2014-09-30
• Results First Submitted QC: 2014-09-30
• Results First Posted: 2014-10-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-07
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACH-0143102 plus ribavirin daily	ACH-0143102	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.
ACH-0143102 plus ribavirin daily	Ribavirin	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.

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response At 12 Weeks (SVR12)	12 weeks following the last dose	To determine the incidence of the SVR12 after the completion of dosing with ACH-0143102 plus ribavirin, reported as hepatitis C virus ribonucleic acid less than the limit of quantification at that time point.