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NCT01580995 · ClinicalTrials.gov registry record · Phase 2
Herpes Simplex Type 1 Suppression in Hepatitis C
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT01580995: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT01580995 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01580995, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, also known as herpes labialis, but most persons do not have any symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic hepatitis C infection. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and patients will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi.
Primary Outcome
Measure change in HCV RNA viral load in treatment group as compared with placebo
Interventions
- DRUG Placebo
- DRUG Valacyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT01580995 record still lists
NCT01580995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01580995 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01580995 about?
NCT01580995 is a clinical study titled "Herpes Simplex Type 1 Suppression in Hepatitis C". The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, als...
What is the current status of trial NCT01580995?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2012-04. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01580995?
The interventions under investigation include: Placebo (DRUG), Valacyclovir (DRUG).
Who is sponsoring clinical trial NCT01580995?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01580995's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 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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