Study Stopped
Nephrotoxicity
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ACH-0137171 in Participants With Chronic Hepatitis C Infection
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects With Chronic Hepatitis C Infection
1 other identifier
interventional
30
3 countries
9
Brief 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2006
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedStudy Start
First participant enrolled
November 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2007
CompletedSeptember 15, 2022
September 1, 2022
November 17, 2006
September 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
To assess the short-term safety and tolerability of multiple, escalating, oral doses of ACH-0137171 in subjects with chronic hepatitis C infection.
To characterize the plasma pharmacokinetics of ACH-0137171 following administration of multiple, escalating, oral doses in subjects with chronic hepatitis C infection.
To assess the antiviral activity of ACH-0137171 as measured by plasma HCV RNA levels in subjects with chronic hepatitis C infection following administration of multiple, escalating, oral doses.
To assess the correlation between antiviral activity and pharmacokinetic parameters.
Secondary Outcomes (2)
To perform viral dynamic and pharmacodynamic modeling of ACH 0137171 virologic response.
To assess the biochemical response of ACH-0137171 as measured by the change from baseline of serum ALT and AST levels.
Interventions
Eligibility Criteria
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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Clinical Trial Site
Phoenix, Arizona, 85054, United States
Clinical Trial Site
La Jolla, California, 92093, United States
Clinical Trial Site
San Francisco, California, 94143, United States
Clinical Trial Site
Boston, Massachusetts, 02215, United States
Clinical Trial Site
New York, New York, 10029, United States
Clinical Trial Site
Dallas, Texas, 75208, United States
Clinical Trial Site
San Antonio, Texas, 78215, United States
Clinical Trial Site
Berlin, BE 14050, Germany
Clinical Trial Site
Utrecht, 6584 CX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2006
First Posted
November 22, 2006
Study Start
November 30, 2006
Study Completion
March 31, 2007
Last Updated
September 15, 2022
Record last verified: 2022-09