search
Back to results

Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACH-126,443
Lamivudine
Placebo
Sponsored by
Alexion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring E-antigen Positive, Treatment-naive Chronic Hepatitis B, Achillion

Eligibility Criteria

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

Inclusion Criteria: Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months. Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter. Hepatitis B e-antigen positive. Human immunodeficiency virus negative. Basic hematologic and chemistry parameters within acceptable limits (defined in protocol). No need for excluded medications. Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection. Exclusion Criteria: Human immunodeficiency virus infection. Hepatitis C co-infection. Concurrent systemic antiviral treatment. Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past. Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start. Alcohol abuse. Pregnancy or breast-feeding. Inability to tolerate oral medication. Aspartate aminotransferase > 7.0 times the upper limit of normal. Alanine aminotransferase > 7.0 times the upper limit of normal. Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements. Use of any investigational drug.

Sites / Locations

  • Clinical Trial Site
  • Clinical Trial Site
  • Clinical Trial Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 26, 2002
Last Updated
February 16, 2021
Sponsor
Alexion
Collaborators
Achillion, a wholly owned subsidiary of Alexion
search

1. Study Identification

Unique Protocol Identification Number
NCT00034359
Brief Title
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
Official Title
A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
January 2003 (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

5. Study Description

Brief Summary
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
Detailed Description
Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
E-antigen Positive, Treatment-naive Chronic Hepatitis B, Achillion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ACH-126,443
Other Intervention Name(s)
beta-L-Fd4C
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Placebo

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months. Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter. Hepatitis B e-antigen positive. Human immunodeficiency virus negative. Basic hematologic and chemistry parameters within acceptable limits (defined in protocol). No need for excluded medications. Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection. Exclusion Criteria: Human immunodeficiency virus infection. Hepatitis C co-infection. Concurrent systemic antiviral treatment. Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine for more than 6 months at any time in the past. Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start. Alcohol abuse. Pregnancy or breast-feeding. Inability to tolerate oral medication. Aspartate aminotransferase > 7.0 times the upper limit of normal. Alanine aminotransferase > 7.0 times the upper limit of normal. Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements. Use of any investigational drug.
Facility Information:
Facility Name
Clinical Trial Site
City
Sofia
Country
Bulgaria
Facility Name
Clinical Trial Site
City
Belgrade
Country
Former Yugoslavia
Facility Name
Clinical Trial Site
City
Novi Sad
Country
Former Yugoslavia

12. IPD Sharing Statement

Learn more about this trial

Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection

We'll reach out to this number within 24 hrs