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NCT04950712 · ClinicalTrials.gov registry record
An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.
A clinical trial of Herpes Genitalis, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- 537
- Enrollment target
- 20
- Study locations
NCT04950712: Completed study of Herpes Genitalis, sponsored by GlaxoSmithKline.
NCT04950712 is a study of Herpes Genitalis that has completed, run by GlaxoSmithKline. The registered enrollment target is 537 participants. The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04950712, a study of Herpes Genitalis, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- 537 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe. More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.
Primary Outcome
Genital HSV-2 recurrence is defined as presence of lesions in anogenital area (swelling, blisters, sores, crusts) and, a positive HSV-2 PCR test.
Conditions Studied
Interventions
- PROCEDURE Blood sampling
- PROCEDURE Anogenital lesion swab collection
Study Locations (20)
Florida
- GSK Investigational Site - Miami
- GSK Investigational Site - Miami
- GSK Investigational Site - Miami
- GSK Investigational Site - Plantation
California
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - San Francisco
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - Fort Worth
- GSK Investigational Site - Houston
Georgia
- GSK Investigational Site - Marietta
- GSK Investigational Site - Smyrna
Missouri
- GSK Investigational Site - Kansas City
- GSK Investigational Site - St Louis
New Jersey
- GSK Investigational Site - Lawrenceville
- GSK Investigational Site - Newark
Massachusetts
- GSK Investigational Site - Boston
Ohio
- GSK Investigational Site - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 2021-06-09 |
| Est. Completion | 2024-03-14 |
What the finished NCT04950712 record still lists
NCT04950712 is an observational study that tracks outcomes without assigning an intervention. The registered 537 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Herpes Genitalis appearing as the primary indexed condition, and to 2 interventions - of which Blood sampling is the first listed.
NCT04950712 names 20 study sites across 10 states, led by Florida, California, Texas.
Frequently Asked Questions
What is clinical trial NCT04950712 about?
NCT04950712 is a clinical study titled "An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.". The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe. More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well a...
What is the current status of trial NCT04950712?
This trial is currently completed. The enrollment target is 537 participants. The study started on 2021-06-09. Estimated completion is 2024-03-14.
What conditions does trial NCT04950712 study?
This clinical trial studies the following conditions: Herpes Genitalis.
What interventions are being tested in trial NCT04950712?
The interventions under investigation include: Blood sampling (PROCEDURE), Anogenital lesion swab collection (PROCEDURE).
Who is sponsoring clinical trial NCT04950712?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04950712 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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