Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B

February 16, 2021 updated by: Alexion

A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of 12 Weeks Oral Treatment With ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B

The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Evaluation of the safety and antiviral activity of 3 dose levels of ACH126, 433 over a 12-week treatment in the population is described.

Study Type

Interventional

Enrollment

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L5
        • Clinical Trial Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Clinical Trial Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Clinical Trial Site
    • Quebec
      • Montréal, Quebec, Canada, H2X 3J4
        • Clinical Trial Site
  • China
      • Hong Kong, China
        • Clinical Trial Site
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Clinical Trial Site
      • Orange, California, United States, 92868
        • Clinical Trial Site
      • Pasadena, California, United States, 91105
        • Clinical Trial Site
      • San Francisco, California, United States, 94143
        • Clinical Trial Site
    • Florida
      • Miami, Florida, United States, 33136
        • Clinical Trial Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Clinical Trial Site
      • Chicago, Illinois, United States, 60612
        • Clinical Trial Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Clinical Trial Site
    • New York
      • New York, New York, United States, 10021
        • Clinical Trial Site
    • Texas
      • Dallas, Texas, United States, 75246
        • Clinical Trial Site
      • Dallas, Texas, United States, 75390
        • Clinical Trial Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Clinical Trial Site
    • Washington
      • Seattle, Washington, United States, 98195
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Chronic HBV infection, known to be hepatitis B surface antigen (HbsAg) positive ≥ 6 months

  • On lamivudine, either 100 or 150 milligrams daily for the treatment of chronic hepatitis B infection and exhibit a 2-3 log decrease in HBV deoxyribonucleic acid (DNA) levels followed by a rebound of at least 1.5 log HBV DNA or

    • Achieved an HBV DNA level of < 10,000 copies/milliliter (mL) HBV DNA on at least 2 occasions and have rebounded to > 100,000 copies/mL HBV DNA, or
    • Have a demonstrable lamivudine -resistant genotype regardless of treatment history.
  • Hepatitis B e-antigen positive.
  • Human immunodeficiency virus (HIV) negative.
  • Serum alanine aminotransferase ≥ 1.5 and ≤ 10x times the upper limit of normal (ULN).
  • Hemoglobin ≥ 10 grams/deciliter or hematocrit ≥ 30% (in the absence of blood transfusions or erythropoietin treatment in the preceding 2 weeks).
  • Platelet count >75,000/cubic millimeters (in the absence of ongoing granulocyte colony-stimulating factor therapy).
  • Serum creatinine < 1.1x the ULN.
  • Negative radiologic screening test (ultrasound, computerized tomography scan, or magnetic resonance imaging) for hepatocellular carcinoma within 6 months prior to entry.
  • Prothrombin time/international normalize ratio < 2.
  • Participants of reproductive capability must utilize an approved form of birth control.
  • All women of child-bearing capability must have a negative serum or urine pregnancy test (minimum sensitivity of 24 international units/liter of beta human chorionic gonadotropin) within 72 hours prior to the start of study medication.
  • Participants must be able to provide written informed consent.
  • Participant must be available for follow-up for a period of 20 weeks.

Exclusion Criteria

  • HIV infection.
  • Hepatitis C co-infection.
  • Alcohol abuse.
  • Pregnancy or breast-feeding.
  • Inability to tolerate oral medication.
  • Any clinical condition or prior therapy that, in the Investigator's opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.
  • Use of any investigational drug.
  • Participants with decompensated liver disease.
  • Use of any concomitant herbal treatments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion

Collaborators

Achillion, a wholly owned subsidiary of Alexion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

June 21, 2002

First Submitted That Met QC Criteria

June 24, 2002

First Posted (Estimate)

June 25, 2002

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACH443-005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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