Expired Study
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Webster, Texas 77598


Purpose:

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).


Study summary:

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.


Criteria:

Inclusion Criteria: - Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash - Have zoster-related pain - Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash Exclusion Criteria: - Have multidermal or disseminated AHZ - Have facial, ophthalmologic or oral manifestations - Have received Zostavax


Study is Available At:


Original ID:

CTRV-FV-2-007


NCT ID:

NCT02412917


Secondary ID:


Study Acronym:


Brief Title:

A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia


Official Title:

A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster Associated Pain


Overall Status:

Terminated


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

30 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

ContraVir Pharmaceuticals, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

237


Enrollment Type:

Actual


Overall Contact Information

Official Name:John Sullivan-Bolyai
Study Director
CMO

Study Dates

Start Date:June 2015
Completion Date:November 2017
Completion Type:Actual
Primary Completion Date:November 2017
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:December 20, 2017
First Received Date:March 23, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
Time Frame:Day 1 to Day 120
Safety Issues:False
Description:efficacy measure
Outcome Type:Secondary Outcome
Measure:Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
Time Frame:Day 1 to Day 120
Safety Issues:False
Description:efficacy measure
Outcome Type:Secondary Outcome
Measure:The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
Time Frame:Day 1 to Day 120
Safety Issues:False
Description:efficacy measure
Outcome Type:Secondary Outcome
Measure:The number and classification of adverse events in 2 dosing regimens of FV-100
Time Frame:Day 1 to Day 120
Safety Issues:False
Description:Safety measure
Outcome Type:Secondary Outcome
Measure:The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID
Time Frame:Day 1 to Day 120
Safety Issues:False
Description:Pharmacokinetic

Study Interventions

Intervention Type:Drug
Name:FV-100
Description:antiviral nucleoside analog
Arm Name:FV-100 400 mg QD
Other Name:antiviral nucleoside analog
Intervention Type:Drug
Name:valacyclovir
Description:antiviral nucleoside analog
Arm Name:valacyclovir
Other Name:valtrex

Study Arms

Study Arm Type:Active Comparator
Arm Name:valacyclovir
Description:valacyclovir 1000mg TID
Study Arm Type:Experimental
Arm Name:FV-100 400mg BID
Description:FV-100 400mg BID(total daily dose of 800mg)
Study Arm Type:Experimental
Arm Name:FV-100 400 mg QD
Description:FV-100 400mg QD

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:ContraVir Pharmaceuticals, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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