ICVT in HPV-induced Genital Lesions of Immunocompromised and Immunocompetent Patients (NCT03334240) | Clinical Trial Compass
TerminatedPhase 2
ICVT in HPV-induced Genital Lesions of Immunocompromised and Immunocompetent Patients
Stopped: Lack of effect in interim analysis
Netherlands28 participantsStarted 2017-10-05
Plain-language summary
This study is intended to explore and evaluate the pharmacodynamics and clinical efficacy of the ionic contra-viral therapy CLS003 in immunocompromised and immunocompetent patients with benign and premalignant HPV-induced genital lesions
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients ≥ 18 years 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.
✓. In case of immunocompromised patients including but not limited to; patients receiving immunosuppressive therapy for any reason, patients with auto-immune disease, HIV patients, transplantation patients
✓. In case of genital warts patient group(s): have at least 3 genital warts (only applicable to Study Part 1)
✓. In case of vulvar HSIL: at least one lesion that can be accurately measured 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 to Study Part 1)
✓. 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)
✓. Able to participate and willing to give written informed consent and to comply with the study restrictions
✓. Ability to communicate well with the investigator in the Dutch language
✓. Willing to refrain from using other topical products in the treatment area, or prohibited medications for the duration of the study
Exclusion criteria
✕
What they're measuring
1
Lesion (vulvar HSIL or wart) size reduction
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
2
Change in patient-reported outcomes
Timeframe: Through study completion, up to 20 weeks
3
HPV viral load assessment
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
4
Change in the HPV viral load
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
5
Mean HPV viral load
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
6
Histology (regression of vulvar HSIL or AGWs to no dysplasia, HPV genotyping)
Timeframe: Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study)
7
Local immunity status
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
. 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
✕. Have used or received any topical genital wart treatment, cryotherapy, electrocoagulation, surgery in the treatment area within 28 days prior to enrolment
✕. Have used or received any topical vulvar HSIL treatment, laser therapy or surgery in the treatment area within 28 days prior to enrolment
✕. Have any current relevant skin infections in the treatment area other than genital warts (inclusively, but not limited to atopic dermatitis, lichen sclerosis, lichen planus or psoriasis)
✕. Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide
✕. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times in the past year
✕. Loss or donation of blood over 500 mL within three months prior to screening.
Percentage clearance of vulvar HSIL lesions
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
9
Proportion of patients with all vulvar HSIL lesions cleared
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
10
Histology (regression of vulvar HSIL to no dysplasia)
Timeframe: Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study)
11
Histological recurrence in the Part 1 follow-up period
Timeframe: Day 84, 126
12
Percentage clearance of genital warts
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
13
Proportion of patients with all genital warts cleared
Timeframe: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study)
14
Clinical recurrence in the Part 1 follow-up period