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

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
ACH-0143102
Ribavirin
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females 18 years and older
  • Clinical diagnosis of hepatitis C with genotype 1b
  • Chronic hepatitis C treatment naive subjects
  • IL28B genotype CC
  • HCV RNA > 10000 IU/mL at screening
  • Females must be willing to use two effective methods of contraception during dosing period and for six months after the last dose of ribavirin.
  • Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months after the last dose of ribavirin. Males must agree to not donate sperm while enrolled in the study and for six months after the last dose of ribavirin.
  • Willing to participate in all study activities and all study requirements.

Exclusion Criteria:

  • BMI>36
  • Pregnant or nursing females
  • Clinically significant laboratory abnormalities at screening
  • Previous participation in a clinical trial with protease inhibitor and/or NS5A inhibitor
  • HIV 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ACH-0143102 plus ribavirin daily

    Arm 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 2, 2012
    Last Updated
    August 7, 2023
    Sponsor
    Alexion
    Collaborators
    Achillion, a wholly owned subsidiary of Alexion
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01700179
    Brief Title
    Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    September 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alexion
    Collaborators
    Achillion, a wholly owned subsidiary of Alexion

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C Infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    8 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ACH-0143102 plus ribavirin daily
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    ACH-0143102
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Primary Outcome Measure Information:
    Title
    Sustained Virologic Response At 12 Weeks (SVR12)
    Description
    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.
    Time Frame
    12 weeks following the last dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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