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NCT01994486 · ClinicalTrials.gov registry record · Phase 2
Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01994486: Completed Phase 2 study, sponsored by University of Florida.
NCT01994486 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01994486, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.
Primary Outcome
Study drug adherence and adverse events were collected on all enrolled subjects and graded using the DAIDS scale. Any adverse events leading to discontinuation of both Telaprevir and Sofosbuvir were collected and are hereby reported.
Interventions
- DRUG Telaprevir and Sofosbuvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01994486 record still lists
NCT01994486 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Telaprevir and Sofosbuvir is the first listed.
NCT01994486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01994486 about?
NCT01994486 is a clinical study titled "Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1". This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.
What is the current status of trial NCT01994486?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-12. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01994486?
The interventions under investigation include: Telaprevir and Sofosbuvir (DRUG).
Who is sponsoring clinical trial NCT01994486?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01994486's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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