Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
Stopped early · Phase 2
Conditions studied: Chronic Hepatitis B
In brief
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.
Key facts
- Study ID
- NCT00040144
- Run by
- Alexion Pharmaceuticals, Inc.
- People needed
- 85
- Starts
- 2002-07-01
- Expected to finish
- 2003-05-01
- Last updated by the study team
- 2021-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Clinical Trial Site — Los Angeles, California, 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 — Miami, Florida, United States
- Clinical Trial Site — Chicago, Illinois, United States
- Clinical Trial Site — Chicago, Illinois, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — New York, New York, 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 — Seattle, Washington, United States
- Clinical Trial Site — Vancouver, British Columbia, Canada
- Clinical Trial Site — Toronto, Ontario, Canada
- Clinical Trial Site — Toronto, Ontario, Canada
- Clinical Trial Site — Montreal, Quebec, Canada
- Clinical Trial Site — Hong Kong, China
Full record on ClinicalTrials.gov
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