Herpes Zoster Clinical Trial
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
Verified date | December 2017 |
Source | ContraVir Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | TX | Webster | Texas |
Lead Sponsor | Collaborator |
---|---|
ContraVir Pharmaceuticals, Inc. |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03120364 -
Immunogenicity and Safety of NBP608 Compared to Zostavax in Healthy Adult Aged 50 and Over
|
Phase 3 | |
Completed |
NCT01165203 -
Study to Evaluate GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Human Immunodeficiency Virus (HIV)-Infected Subjects
|
Phase 2 | |
Recruiting |
NCT06088745 -
A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
|
Phase 3 | |
Completed |
NCT01385566 -
A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
|
Phase 1 | |
Completed |
NCT01911065 -
T Cell Responses to Varicella Zoster Virus (VZV) Vaccine SLVP020
|
Phase 4 | |
Completed |
NCT01137669 -
ZOSTAVAX® in Renal Transplant Patients
|
Phase 1 | |
Completed |
NCT00550745 -
ZOSTAVAX™ Safety Study in Subjects ≥ 60 Years of Age (V211-020)
|
Phase 4 | |
Completed |
NCT01132716 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
|
N/A | |
Completed |
NCT01132729 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
|
N/A | |
Completed |
NCT02852876 -
Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ASP2151 in Healthy Male Subjects and the Effects of Food
|
Phase 1 | |
Completed |
NCT00231816 -
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)
|
Phase 3 | |
Completed |
NCT05082688 -
Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)
|
Phase 2 | |
Completed |
NCT04099706 -
Treatment of Chronic Postherpetic Pain With Autologous Fat Grafting - A RCT
|
N/A | |
Active, not recruiting |
NCT04091451 -
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles
|
Phase 3 | |
Completed |
NCT02519855 -
Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062)
|
Phase 3 | |
Completed |
NCT04523246 -
Training the Innate Immune System Against SARS-CoV-2 (COVID-19) Using the Shingrix Vaccine in Nursing Home Residents
|
Early Phase 1 | |
Completed |
NCT05047770 -
A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine
|
Phase 3 | |
Completed |
NCT03314103 -
Efficacy Trial of a Vaccine to Prevent Herpes Zoster in Adults Over 40 Years of Age
|
Phase 3 | |
Completed |
NCT01527370 -
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)
|
Phase 3 | |
Completed |
NCT01954251 -
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older
|
Phase 3 |