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

Study Identifier:
ACH443-005
ClinicalTrials.gov Identifier:
NCT00040144
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Hepatitis
Study Drug
  • Drug: ACH126, 433
Date
Jul 2002 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
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.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Hepatitis
Study Drug
  • Drug: ACH126, 433
Date
Jul 2002 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
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.

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Trial Site
Los Angeles, California, United States, 90048
Status
N/A
Location
Clinical Trial Site
Orange, California, United States, 92868
Status
N/A
Location
Clinical Trial Site
Pasadena, California, United States, 91105
Status
N/A
Location
Clinical Trial Site
San Francisco, California, United States, 94143
Status
N/A
Location
Clinical Trial Site
Miami, Florida, United States, 33136
Status
N/A
Location
Clinical Trial Site
Chicago, Illinois, United States, 60612
Status
N/A
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