EUCTR2016-000870-39-NL进行中（未招募）1 期
A phase 2, randomized, vehicle-controlled, double-blind study to explore the efficacy, pharmacodynamics and safety of topical ionic contra-viral therapy (ICVT) comprised of digoxin and furosemide in HPV-induced genital lesions of immunocompromised and immunocompetent patients.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 48
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
入选标准
- •For enrollment of subjects the following criteria must be met:
- •1. Vulvar HSIL or AGW patients, = 18 years of age, in general, stable good health (with the exception of the immunocompromised disorder) as per judgment of the investigator based upon the results of a medical history, physical examination, ECG, chemistry, hematology.
- •2. In case of the immunocompromised patient group(s): having an immunosuppressive disease or receiving immunosuppressive therapy for any reason including but not limited to; patients with auto-immune disease, HIV patients, transplantation patients
- •3. In case of the genital warts patient group(s): have at least 3 genital warts (only applicable for study part 1).
- •4. In case of vulvar HSIL patient group: at least one lesion that can be accurately measured (using RECIST criteria) in at least one dimension with longest diameter =20 mm OR in 2 perpendicular dimensions that when multiplied together give a surface area =120 mm² (only applicable for study part 1).
- •5. If female of childbearing potential, have a negative urine pregnancy test at Screening and Day 0, and is willing to use effective contraception during the study and 3 months afterwards (i.e. oral, implanted, injectable, IUD, diaphragm, condom, tubal ligation, abstinence, or are in a monogamous relationship with a partner who has had a vasectomy)
- •6. Able to participate and willing to give written informed consent and to comply with the study restrictions
- •7. Ability to communicate well with the investigator in the Dutch language
- •8. Willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
- •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 48
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Eligible subjects must meet none of the following exclusion criteria:
- •1.Significant, uncontrolled or unstable disease in any organ system as per judgment of the investigator (regardless of association with the immunosuppressing disorder/therapy), including but not limited to: psychiatric, neurologic, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, hematologic or respiratory disease
- •2.Have used or received any topical genital wart treatment, cryotherapy, electrocoagulation, surgery in the treatment area within 28 days prior to enrolment
- •3.Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the treatment area within 28 days prior to enrolment
- •4.Have any current pathologically relevant skin infections in the treatment area other than genital warts (such as atopic dermatitis, lichen sclerosis, lichen planus or psoriasis)
- •5.Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide
- •6.Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year
- •7.Loss or donation of blood over 500 mL within three months prior to screening.
研究者
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