Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
NCT ID: NCT00040144
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
85 participants
INTERVENTIONAL
2002-07-31
2003-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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ACH126, 433
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Achillion, a wholly owned subsidiary of Alexion
INDUSTRY
Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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ACH443-005
Identifier Type: -
Identifier Source: org_study_id
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