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NCT01497327 · ClinicalTrials.gov registry record · Phase 1
Open-Label Hepatic Impairment Study
A Phase 1 study of Hepatitis C, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT01497327 is a Phase 1 study of Hepatitis C that has completed, run by Gilead Sciences. The registered enrollment target is 24 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01497327, a Phase 1 study of Hepatitis C, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.
Conditions Studied
Interventions
- DRUG PSI-352938
- DRUG PSI-7977
Study Locations (2)
Texas
- - San Antonio
Puerto Rico
- - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01497327
The ClinicalTrials.gov registry entry for NCT01497327 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (99% lower). The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which PSI-352938 is the first listed.
NCT01497327 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Texas, Puerto Rico.
Frequently Asked Questions
What is clinical trial NCT01497327 about?
NCT01497327 is a clinical study titled "Open-Label Hepatic Impairment Study". This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction ...
What is the current status of trial NCT01497327?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-07. Estimated completion is 2012-01.
What conditions does trial NCT01497327 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT01497327?
The interventions under investigation include: PSI-352938 (DRUG), PSI-7977 (DRUG).
Who is sponsoring clinical trial NCT01497327?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01497327 being conducted?
This trial has 2 study locations across Texas, Puerto Rico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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