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Tracking Information | |||||
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First Received Date † | November 17, 2006 | ||||
Last Updated Date | May 10, 2007 | ||||
Start Date † | November 2006 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00401947 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of ACH-0137171 in Subjects With Chronic Hepatitis C Infection | ||||
Official Title † | 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 | ||||
Brief Summary | The purpose of this study is to Investigate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Multiple Doses of ACH-0137171 in Subjects with Chronic Hepatitis C Infection |
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Detailed Description | This is a randomized, double-blind, placebo-controlled, dose escalation study of ACH-0137171 in subjects with chronic HCV infection. Sequential cohorts of 10 subjects will be randomized (8:2) to receive multiple doses of ACH-0137171 or placebo for 4 days (Days 1 through 4) with a single dose on Day 5 followed by a complete pharmacokinetic profile. Dosing will be 300 – 600 mg administered either every 12 hours or every 6 hours (maximum daily dose of 2400 mg). All doses will be administered with food. The dose cohorts are as follows: Study Schema: Cohort 1: 300 mg ACH-0137171/placebo every 12 hours (600 mg/day)* Cohort 2: 300 mg ACH-0137171/placebo every 6 hours (1200 mg/day)* Cohort 3: 600 mg ACH-0137171/placebo every 6 hours (2400 mg/day)* A full review of all safety data will occur following each cohort. Depending on the data, the Sponsor, in consultation with the Principal Investigator(s), may consider modifying the planned dose escalation. The Sponsor may choose to interject an intermediate dose cohort between 2 planned dose escalations or repeat a given dose level, or extend the dosing period, or add an additional cohort. If a similar Grade 3 or 4 adverse event occurs in three or more subjects, and is considered to be at least possibly related to study drug, escalation to a higher dose will not occur. Serial HCV RNA measurements, pharmacokinetic measurements of plasma concentrations of ACH-0137171, and periodic safety monitoring will occur on Days 1 through 5. Additional HCV RNA and PK measurements will be taken on Days 6 through 9. Follow up safety evaluations will be completed out to 14 days after last study drug administration (i.e., on Days 12 and 19). |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment | ||||
Condition † | HCV Infection | ||||
Intervention † | Drug: ACH-0137171 | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Terminated | ||||
Enrollment † | 30 | ||||
Completion Date | March 2007 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Germany, Netherlands | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00401947 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Achillion Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Achillion Pharmaceuticals | ||||
Verification Date | May 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |