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

A Phase 1b, Open-label, Pilot Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Oral ACH-0143102 Administered in Combination With Ribavirin for 12 Weeks in Treatment-naive Subjects With Chronic Hepatitis C Virus Infection Genotype 1b

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.

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis C Infection
• Intervention / Treatment: Drug: ACH-0143102; Drug: Ribavirin

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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Dr. Aasim Sheikh
  • Tennessee
    • Nashville, Tennessee, United States, 37211
      • Dr. Robert Herring Jr
  • Texas
    • Houston, Texas, United States, 77030
      • Victor Ankoma-Sey
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Vinod Rustgi, MD
    • Lynchburg, Virginia, United States, 24501
      • Robert Brennan
    • Norfolk, Virginia, United States, 23502
      • Michael Ryan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: ACH-0143102; Drug: Ribavirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained Virologic Response At 12 Weeks (SVR12)	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.	12 weeks following the last dose

Collaborators and Investigators

• Sponsor: Alexion
• Collaborators: Achillion, a wholly owned subsidiary of Alexion

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: October 2, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimated): October 4, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Blood-Borne Infections; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Infections; Communicable Diseases; Hepatitis; Hepatitis A; Hepatitis C; Virus Diseases; Hepatitis, Chronic; Hepatitis C, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin
• Other Study ID Numbers: ACH102-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No