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NCT01453075 · ClinicalTrials.gov registry record · Phase 1
Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)
A Phase 1 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
NCT01453075: Completed Phase 1 study, sponsored by VA Office of Research and Development.
NCT01453075 is a Phase 1 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01453075, a Phase 1 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes. Some persons with genital herpes have sores in their private areas but most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly used to treat or prevent outbreaks of genital herpes. This medication is already approved by the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved to treat chronic hepatitis C. 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 the persons participating will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 3-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center.
Interventions
- DRUG Placebo
- DRUG Valacyclovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-11 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01453075
The ClinicalTrials.gov registry entry for NCT01453075 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01453075 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01453075 about?
NCT01453075 is a clinical study titled "Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)". The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes. Some persons with genital herpes have sores in their private areas but most persons do not have an...
What is the current status of trial NCT01453075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2011-11. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01453075?
The interventions under investigation include: Placebo (DRUG), Valacyclovir (DRUG).
Who is sponsoring clinical trial NCT01453075?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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