A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ACH-0137171 in Participants With Chronic Hepatitis C Infection

Study Identifier:
ACH171-002
ClinicalTrials.gov Identifier:
NCT00401947
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Other

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ACH-0137171
Date
Nov 2006 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Chronic HCV infection must be documented by positive anti-HCV antibody using a third-generation enzyme immunoassay and persistent detection of HCV RNA in the blood for at least 6 months.
  • Participants must be infected with HCV genotype 1 (line probe assay; INNO-LiPA HCV II, Innogenetics) and maybe treatment-naïve or treatment-experienced (treatment experienced specifically means prior treatment with interferon, standard or pegylated, with or without ribavirin with therapy stopped \> 6 months prior to screening).
  • Eligible participants must have had alanine aminotransferase and aspartate aminotransferase \< 5 x upper limit of normal (ULN), plasma HCV RNA \> 5 log10 international units (IU)/milliliter (mL), and have had no clinical or laboratory evidence of hepatic decompensation for inclusion (must have platelets \> 100,000/cubic millimeter \[mm\^3\], total bilirubin \< 1.5 x ULN, prothrombin time \< 1.5 x ULN, or albumin \> 3.0 grams/deciliter \[g/dL\] for inclusion).
  • Women were eligible if not pregnant or breast-feeding.
  • Women of childbearing potential (that is, not surgically sterile or confirmed post menopausal) must have had confirmed negative pregnancy tests. All participants must practice a medically acceptable form of contraception.
Exclusion Criteria
  • Human immunodeficiency virus or hepatitis B virus co-infection known cirrhosis.
  • Prior history of clinical hepatic decompensation (ascites, jaundice, encephalopathy, or variceal hemorrhage), alcoholic or other forms of chronic liver disease, evidence of hepatocellular carcinoma (α-fetoprotein \> 50 nanograms/mL), creatinine clearance \< 80 mL/minute (using Cockcroft-Gault equation), hemoglobin \< 10 g/dL, neutrophils \< 1500/mm\^3, and abnormal thyroid function tests (thyroid stimulating hormone \> 2.5 microIU/mL, free T4 \> ULN), or, a positive test result for illicit drugs, alcohol, or drug abuse within the past 12 months.
  • Participants who have had significant gastrointestinal, thyroid, renal, cardiovascular, pulmonary, oncologic, or neurological disease, or who are currently receiving immunomodulators (corticosteroids), investigational, nephrotoxic or hepatotoxic drugs (for example, phenytoin, carbamazepine, isonicotinic acid hydrazide, azole anti-fungal agents such as ketoconazole, and aminoglycoside antibiotics), non-steroidal anti-inflammatory agents, ibuprofen or acetaminophen (on a daily basis) will also be excluded.
Sex
Female & Male
Age
18 - 60 Years

Study Details

Medical Condition
  • Unmapped
Study Drug
  • Drug: ACH-0137171
Date
Nov 2006 - N/A
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 60 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Chronic HCV infection must be documented by positive anti-HCV antibody using a third-generation enzyme immunoassay and persistent detection of HCV RNA in the blood for at least 6 months.
  • Participants must be infected with HCV genotype 1 (line probe assay; INNO-LiPA HCV II, Innogenetics) and maybe treatment-naïve or treatment-experienced (treatment experienced specifically means prior treatment with interferon, standard or pegylated, with or without ribavirin with therapy stopped \> 6 months prior to screening).
  • Eligible participants must have had alanine aminotransferase and aspartate aminotransferase \< 5 x upper limit of normal (ULN), plasma HCV RNA \> 5 log10 international units (IU)/milliliter (mL), and have had no clinical or laboratory evidence of hepatic decompensation for inclusion (must have platelets \> 100,000/cubic millimeter \[mm\^3\], total bilirubin \< 1.5 x ULN, prothrombin time \< 1.5 x ULN, or albumin \> 3.0 grams/deciliter \[g/dL\] for inclusion).
  • Women were eligible if not pregnant or breast-feeding.
  • Women of childbearing potential (that is, not surgically sterile or confirmed post menopausal) must have had confirmed negative pregnancy tests. All participants must practice a medically acceptable form of contraception.
Exclusion Criteria
  • Human immunodeficiency virus or hepatitis B virus co-infection known cirrhosis.
  • Prior history of clinical hepatic decompensation (ascites, jaundice, encephalopathy, or variceal hemorrhage), alcoholic or other forms of chronic liver disease, evidence of hepatocellular carcinoma (α-fetoprotein \> 50 nanograms/mL), creatinine clearance \< 80 mL/minute (using Cockcroft-Gault equation), hemoglobin \< 10 g/dL, neutrophils \< 1500/mm\^3, and abnormal thyroid function tests (thyroid stimulating hormone \> 2.5 microIU/mL, free T4 \> ULN), or, a positive test result for illicit drugs, alcohol, or drug abuse within the past 12 months.
  • Participants who have had significant gastrointestinal, thyroid, renal, cardiovascular, pulmonary, oncologic, or neurological disease, or who are currently receiving immunomodulators (corticosteroids), investigational, nephrotoxic or hepatotoxic drugs (for example, phenytoin, carbamazepine, isonicotinic acid hydrazide, azole anti-fungal agents such as ketoconazole, and aminoglycoside antibiotics), non-steroidal anti-inflammatory agents, ibuprofen or acetaminophen (on a daily basis) will also be excluded.

Protocol Summary

The purpose of this study was to investigate the safety, tolerability, pharmacokinetics (PK), and antiviral activity of multiple doses of ACH-0137171 in participants with chronic hepatitis C virus (HCV) infection.

Trial Locations

Location
Status
Location
Clinical Trial Site
Phoenix, Arizona, United States, 85054
Status
N/A
Location
Clinical Trial Site
La Jolla, California, United States, 92093
Status
N/A
Location
Clinical Trial Site
San Francisco, California, United States, 94143
Status
N/A
Location
Clinical Trial Site
Boston, Massachusetts, United States, 02215
Status
N/A
Location
Clinical Trial Site
New York, New York, United States, 10029
Status
N/A
Location
Clinical Trial Site
Dallas, Texas, United States, 75208
Status
N/A
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