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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02412917
Other study ID # CTRV-FV-2-007
Secondary ID
Status Terminated
Phase Phase 3
First received March 23, 2015
Last updated December 20, 2017
Start date June 2015
Est. completion date November 2017

Study information

Verified date December 2017
Source ContraVir Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 237
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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 Design


Intervention

Drug:
FV-100
antiviral nucleoside analog
valacyclovir
antiviral nucleoside analog

Locations

Country Name City State
United States TX Webster Texas

Sponsors (1)

Lead Sponsor Collaborator
ContraVir Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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