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

Stopped early · Phase 2

Conditions studied: HCV Infection

In brief

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.

Key facts

Study ID

NCT00401947

Run by

Alexion Pharmaceuticals, Inc.

People needed

30

Starts

2006-11-30

Expected to finish

2007-03-31

Last updated by the study team

2022-09-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Trial Site — Phoenix, Arizona, United States
• Clinical Trial Site — La Jolla, California, United States
• Clinical Trial Site — San Francisco, California, 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 — San Antonio, Texas, United States
• Clinical Trial Site — Berlin, Germany
• Clinical Trial Site — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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