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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: Completed Phase 1 study of Hepatitis C, sponsored by Gilead Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To characterize the pharmacokinetics (PK) of PSI-352938 over 7 days of dosing with PSI-352938 in HCV-infected patients with varying degrees of hepatic impairment compared to historical PK data.
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 |
What the finished NCT01497327 record still lists
NCT01497327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01497327's enrollment target sits among peer trials
24 91st of 106 higher than 16 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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