search
Back to results

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

Primary Purpose

Chronic Hepatitis B

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ACH126, 433
Sponsored by
Alexion
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring E-Antigen Positive, Lamivudine-resistant Chronic Hepatitis B, Achillion

Eligibility Criteria

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

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 21, 2002
Last Updated
February 16, 2021
Sponsor
Alexion
Collaborators
Achillion, a wholly owned subsidiary of Alexion
search

1. Study Identification

Unique Protocol Identification Number
NCT00040144
Brief Title
Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Safety concerns
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 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 antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
E-Antigen Positive, Lamivudine-resistant Chronic Hepatitis B, Achillion

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ACH126, 433
Other Intervention Name(s)
b-L-Fd4C

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Clinical Trial Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Clinical Trial Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Clinical Trial Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Clinical Trial Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Clinical Trial Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Clinical Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Clinical Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Clinical Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Clinical Trial Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Clinical Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Clinical Trial Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L5
Country
Canada
Facility Name
Clinical Trial Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Clinical Trial Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Clinical Trial Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Clinical Trial Site
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs