NCT04950712已完成不适用
A Descriptive, Prospective, Multi-country, Multicentre Study to Assess Performance of Genital Herpes Simplex Virus-2 (HSV-2) Related Disease Endpoints Based on Patient-reported Health Outcomes, Self-swabbing Collected Via Decentralised Approach in Patients ≥ 18 Years of Age in the United States and Europe.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 537
- 试验地点
- 1
- 主要终点
- Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman ≥18 years old.
- •Written informed consent obtained from the patient prior to performance of any study-specific procedure.
- •History of at least one episode of HSV-2 genital herpes lesions in the 12 months preceding the screening, and seropositive for HSV-2 as determined by Western blot OR PCR-positive for HSV-2 (newly diagnosed patients).
- •Patients who are medically stable in the opinion of the investigator.
- •Patients who, in the opinion of the investigator, are able to understand and comply with the study requirements (attend regular telephone calls/study site visits/home visits/self-completion of questionnaires, self-swabbing).
- •Seronegative for HIV, as determined by laboratory testing. Patients documented to be positive to HIV will not be eligible for study participation
排除标准
- •Prior receipt of a vaccine or candidate vaccine containing HSV antigens.
- •Immunocompromised patients, as per medical history and investigator judgement.
- •Other genital tract disorders or sexually transmitted diseases that may interfere with the assessment of the study (as per investigator's judgement).
结局指标
主要结局
Number of patients with Polymerase Chain Reaction (PCR)-confirmed genital HSV-2 recurrences
时间窗: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)
Genital HSV-2 recurrence is defined as presence of lesions in anogenital area (swelling, blisters, sores, crusts) and, a positive HSV-2 PCR test.
Duration of PCR-confirmed genital HSV-2 recurrences
时间窗: During the 2-year follow-up period (from Enrolment Visit at Day 1 up to Month 24)
Duration of a recurrence is defined as number of consecutive days with the presence of HSV-2 lesion(s) and associated prodromal symptoms and/or erythema (skin redness).
次要结局
- Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes symptoms checklist (HSC) questionnaire(From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months))
- Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Herpes outbreak impact (HOIQ) questionnaire(From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months))
- Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of severity (PGI-S) questionnaire(From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months))
- Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HOIQ questionnaire(From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months))
- Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by EuroQoL-5 dimension (EQ-5D) health questionnaire(At Enrolment Visit (Day 1) and at Day 1 of each PCR-confirmed recurrence)
- Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by Recurrent genital herpes quality-of-life (RGHQoL) questionnaire(At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24)
- Change in severity of symptoms during HSV-2 genital herpes recurrence assessed by Patient global impression of change (PGI-C) questionnaire(From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months))
- Number of self-swabs collected during genital HSV-2 recurrences throughout the study period(Throughout the study period (from Day 1 up to Month 24))
- Number of patients reporting genital HSV-2 recurrences by using eDiary(Throughout the study period (from Day 1 up to Month 24))
- Long-term impact on the quality-of-life of patients with symptomatic HSV-2 genital herpes as assessed by short form-12 questionnaire(At Enrolment Visit (Day 1) and every 3 months until study completion at Month 24)
- HSV-2 PCR self-swab results(At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months))
- Impact of HSV-2 genital herpes recurrence on patients' daily functioning and quality-of-life as assessed by HSC questionnaire(From the onset of recurrence until the end of the episode, assessed throughout the study period (for approximately 24 months))
- HSV-2 PCR investigator swab results(At first genital HSV-2 recurrence, assessed throughout the study period (for approximately 24 months))
- Number of patients reporting genital HSV-2 recurrence during the 3 monthly calls with the investigator(Throughout the study period (from Day 1 up to Month 24))
研究者
研究点 (1)
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