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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040144
• Other study ID #: ACH443-005
• Status: Terminated
• Phase: Phase 2
• Start date: July 2002
• Est. completion date: May 2003

Study information

• Verified date: February 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ACH126, 433

Locations

Country	Name	City	State
Canada	Clinical Trial Site	Montréal	Quebec
Canada	Clinical Trial Site	Toronto	Ontario
Canada	Clinical Trial Site	Toronto	Ontario
Canada	Clinical Trial Site	Vancouver	British Columbia
China	Clinical Trial Site	Hong Kong
United States	Clinical Trial Site	Boston	Massachusetts
United States	Clinical Trial Site	Chicago	Illinois
United States	Clinical Trial Site	Chicago	Illinois
United States	Clinical Trial Site	Dallas	Texas
United States	Clinical Trial Site	Dallas	Texas
United States	Clinical Trial Site	Fairfax	Virginia
United States	Clinical Trial Site	Los Angeles	California
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	New York	New York
United States	Clinical Trial Site	Orange	California
United States	Clinical Trial Site	Pasadena	California
United States	Clinical Trial Site	San Francisco	California
United States	Clinical Trial Site	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Countries where clinical trial is conducted

United States,  Canada,  China,