Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic … (NCT00040144) | Clinical Trial Compass
TerminatedPhase 2
Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
Stopped: Safety concerns
United States85 participantsStarted 2002-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 internatio…