Study of Telaprevir in Subjects With Hepatic Impairment
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00509210 |
Recruitment Status
:
Completed
First Posted
: July 31, 2007
Last Update Posted
: October 29, 2008
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Sponsor:
Vertex Pharmaceuticals Incorporated
Information provided by:
Vertex Pharmaceuticals Incorporated
Tracking Information | ||||
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First Submitted Date ICMJE | July 30, 2007 | |||
First Posted Date ICMJE | July 31, 2007 | |||
Last Update Posted Date | October 29, 2008 | |||
Study Start Date ICMJE | September 2007 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Pharmacokinetics | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00509210 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Telaprevir in Subjects With Hepatic Impairment | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Hepatic Insufficiency | |||
Intervention ICMJE | Drug: telaprevir (VX-950) | |||
Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date | June 2008 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00509210 | |||
Other Study ID Numbers ICMJE | VX06-950-012 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Vertex Pharmaceuticals Incorporated | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Vertex Pharmaceuticals Incorporated | |||
Verification Date | October 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |