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

Alexion Pharmaceuticals

Status and phase

Terminated

Phase 2

Conditions

Chronic Hepatitis B

Treatments

Drug: ACH126, 433

Study type

Interventional

Funder types

Industry

Identifiers

NCT00040144

ACH443-005

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.