Genital Herpes Clinical Trial
Official title:
A Two-Stage, Randomized, Double-Blind, Dose-Ranging, Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 on HSV Shedding in Adults With Recurrent Genital HSV-2 Infection.
To evaluate the efficacy of two dose levels of UB-621 administration in reducing the HSV-2 genital shedding rate in patients with recurrent genital HSV-2 infection.
This is a 2-stage, randomized, double-blind, dose-ranging, multi-center phase 2 study designed to evaluate the efficacy, safety, and PK of UB-621 given at 2.5 or 5 mg/kg in adult subjects with recurrent genital HSV-2 infection. The study consists of 2 stages of enrollments, in which 40 subjects will be enrolled in the first stage and randomly assigned to receive placebo or UB-621 at 2.5 mg/kg in a 1:3 ratio into Cohort 1 at Bv6 (Day B57), and another 40 subjects will be enrolled in the second stage and randomly assigned to receive placebo or UB-621 at 5 mg/kg in a 1:3 ratio into Cohort 2 at Bv6 (Day B57) after review by the Data Safety Monitoring Committee (DSMC). The DSMC will review safety data after all subjects of Cohort 1 complete the visit Fv6 (Day F28) and make the recommendation whether to proceed with enrollment for Cohort 2. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT06033261 -
A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes
|
Phase 1/Phase 2 | |
| Completed |
NCT00362297 -
Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
|
Phase 4 | |
| Completed |
NCT01132729 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions
|
N/A | |
| Completed |
NCT01132716 -
Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions
|
N/A | |
| Completed |
NCT03831165 -
Melatonin Effects on Genital Herpes in Brazilian Women
|
Phase 4 | |
| Terminated |
NCT01658826 -
Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes
|
Phase 2 | |
| Completed |
NCT00262106 -
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
|
Phase 3 | |
| Completed |
NCT01346475 -
Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2
|
Phase 4 | |
| Completed |
NCT01390805 -
Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)
|
N/A | |
| Terminated |
NCT03146403 -
Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection
|
Phase 2 | |
| Completed |
NCT03080961 -
The VIBLOK SAfety and perFormancE Trial
|
N/A | |
| Completed |
NCT00231049 -
Trial Evaluating Safety, Tolerability and Immune Response of AG-707
|
Phase 1 | |
| Completed |
NCT00306787 -
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes
|
Phase 3 | |
| Completed |
NCT00495573 -
HSV-2 Shedding Resolution After Acyclovir Treatment
|
N/A | |
| Completed |
NCT00477334 -
Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients
|
Phase 4 | |
| Completed |
NCT01281007 -
Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes
|
Phase 3 | |
| Completed |
NCT01112956 -
Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2
|
N/A | |
| Completed |
NCT00129818 -
A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding
|
Phase 4 | |
| Completed |
NCT00808405 -
GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women
|
N/A | |
| Terminated |
NCT00495716 -
Effect of HSV-2 Suppressive Therapy on Sexual Behavior
|
Phase 4 |