A Phase 3 interventional study of FV-100 and valacyclovir in Shingles, Herpes Zoster and Postherpetic Neuralgia, sponsored by ContraVir Pharmaceuticals, Inc.. Terminated at 1 site in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by ContraVir Pharmaceuticals, Inc. · Phase 3, Interventional, and Prevention
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Among 95 studies in Herpes Zoster with a site in United States — 5 open to participants now, 9 under way, 2 of them phase 3. Herpes Zoster · United States.
Among the 95 studies in Herpes Zoster with a site in United States, this one is the 32nd largest by enrollment of the 85 interventional ones that give a count, is one of 3 that started in 2015, is one of 24 in phase 3, and was the 59th registered.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
Browse Herpes Zoster studies →5 of the 95 studies in Herpes Zoster with a site in United States are open now. Recruiting first, the newest first:
Center for Clinical Studies, Texas · Sites in United States
Ages 18+ · Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+ · Healthy volunteers
Loyola University · Sites in United States
University of Colorado, Denver · Sites in United States
Ages 18–70
Ann & Robert H Lurie Children's Hospital of Chicago · Sites in United States
Ages 19–40
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.
This study: 30 Years and older · all sexes · no healthy volunteers.
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95 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 32 · Phase 3 25 · Phase 4 6
First in 1993; this study’s year is marked. 3 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 237 is above the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Median enrollment 150 across the 85 interventional studies, 149 across the 8 observational. Of the 80 that completed or were terminated, 37 (46%) have results posted.
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55 of 95 have an industry lead sponsor. The 10 most frequent:
ContraVir Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
ContraVir Pharmaceuticals, Inc. has 2 studies filed under Herpes Zoster — fewer than ten, so there is no comparison to draw.
3 of the studies in Herpes Zoster with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05371080Phase 3GlaxoSmithKlineA Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults | 2027-08-23 |
| NCT05580458National Institute of Allergy and Infectious Diseases (NIAID)Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population | 2027-02-01 |
| NCT06162494Ann & Robert H Lurie Children's Hospital of ChicagoRecombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients | 2027-03-31 |
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Among the 95 studies in Herpes Zoster with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).
This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.
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Exclusion Criteria:
FV-100 400mg QD
Drug: FV-100
FV-100 400mg BID(total daily dose of 800mg)
Drug: FV-100
valacyclovir 1000mg TID
Drug: valacyclovir
antiviral nucleoside analog
Also known as: antiviral nucleoside analog
antiviral nucleoside analog
Also known as: valtrex
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
efficacy measure
Time frame: Day 1 to Day 120
Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
efficacy measure
Time frame: Day 1 to Day 120
The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
efficacy measure
Time frame: Day 1 to Day 120
The number and classification of adverse events in 2 dosing regimens of FV-100
Safety measure
Time frame: Day 1 to Day 120
The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID
Pharmacokinetic
Time frame: Day 1 to Day 120
The record gives a start of Jun 2015, a primary completion of Nov 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: FV-100
ContraVir Pharmaceuticals, Inc.