EUCTR2020-000926-24-DE进行中（未招募）1 期
A Randomised, Double-Blind Phase II Trial of Topical HDIT101 versus Placebo in Patients with Chronic Recurrent HSV-1 Infection and Orolabial Lesion - MATCH-1; Monoclonal Antibody Therapy against Chronic Herpes Simplex Virus 1 Infection
Heidelberg ImmunoTherapeutics0 个研究点目标入组 138 人开始时间: 2020年6月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Ability to provide written, personally signed and dated informed consent to participate in the study.
- •2. Age = 18 years at the time of signing informed consent.
- •3. Understanding, ability, and willingness to fully comply with study interventions and restrictions.
- •4. Seropositive for HSV-1 at screening or if documented within 2 years prior enrolment with a history of chronic recurrent orolabial herpes infection for at least 12 months with at least 6 orolabial recurrences in the last year.
- •5. Three confirmed lesions within 9 months after enrolment.
- •6. Willingness not to use any HSV-suppressant therapy (both approved drugs and non-approved drugs including over-the-counter [OTC] drugs, e.g. herpes patches or supplemental dietary anti-herpetic treatments) except 5% aciclovir cream as optional standard of care (with the exception of the first two outbreaks in the treatment phase).
- •7. Willingness to remove beard or lip piercings if lesion boundaries in this region cannot be evaluated and topical treatment of the entire lesion is compromised (according to judgement of investigator).
- •8. Willingness to self-obtain daily swabs from the orolabial region, to provide photos of the lesions to the study site and to complete questionnaires upon recognition of first symptoms during the study.
- •9. Medical assessment with no clinically significant morbidities or abnormalities as per judgement of the investigator.
- •10. Willingness to use contraceptive methods for 30 days after each treatment (as further described in section 4.5).
- •11. Availability of a mobile phone, tablet or other smart device with a camera, connection to the internet and willingness to use this device for documentation of patient-reported outcomes and photo upload.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 38
排除标准
- •1. Patients who do not develop at least 3 lesions of stage 3 or higher during the 9 months observation phase or do not develop any lesion within 150 days from enrolment visit.
- •2. Patients with herpes keratitis.
- •3. Requirement for immunosuppressive therapy including topical (e.g., rectal, vaginal, cutaneous, etc.) and/or oral and/or parenteral and/or inhaling steroids.
- •4. Any condition that precludes the sampling of up to 215 mL blood over the duration of the study.
- •5. Any known clinically relevant allergies to drugs or any history of severe allergic or anaphylactic reactions.
- •6. Known intolerance to active substance or excipients of the investigational medicinal product or comparator.
- •7. Positive human immunodeficiency virus (HIV) antibody screen, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
- •8. Treatment with an investigational drug in any clinical study within the last 30 days prior to enrolment in this study.
- •9. Prior treatment with HDIT101, e.g. in this or another clinical study.
- •10. Prior vaccination with an HSV type 1/2 vaccine (e.g. experimental) within the last 2 years prior screening.
- •11. Pregnant or breast-feeding women.
- •12. Prior malignant disease (except basal cell carcinoma in situ) if not successfully cured more than 5 years before enrolment.
- •13. Patients who have abnormal skin conditions which are considered clinically significant according to the assessment of the investigator (e.g., acne, eczema, rosacea, psoriasis, albinism, chronic vesiculo-bullous disorders, atopic dermatitis, history of eczema herpeticum).
- •14. Any clinically relevant medical history or current physical or psychiatric illnesses/medical conditions that constitute an unacceptable risk for study participation or make the participant unlikely to fully complete the study in the judgment of the Investigator. This especially applies to currently medicated psychiatric illnesses since this poses an additional risk for pharmacodynamic interaction with IMP.
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