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ICVT in HPV-induced Genital Lesions of Immunocompromised and Immunocompetent Patients

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ClinicalTrials.gov Identifier: NCT03334240
Recruitment Status : Terminated (Lack of effect in interim analysis)
First Posted : November 7, 2017
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Maruho Co., Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
HPV-Induced Genital Lesions Drug: CLS003 Drug: Vehicle Phase 2

Detailed Description:
This study is intended to explore clinical efficacy and safety/tolerability of ICVT as a potential treatment for benign and premalignant HPV-induced genital lesions in immunocompetent and immunosuppressed patients. This includes 3 different patient populations: i) immunocompetent patients with anogenital warts (AGWs), ii) immunocompromised patients with anogenital warts and iii) immunocompromised patients with vulvar high grade squamous intraepithelial neoplasia (HSIL), formerly referred to as usual type vulvar intraepithelial neoplasia (uVIN). Since digoxin / furosemide ICVT's mode of action is in part independent of the immune system and directly targeted to eradicate the causative HPV, we hypothesize this therapy to be of value in this specific group of individuals.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A total of 48 subjects are planned to be enrolled within one of the following three groups: a.) Immunocompetent patients with anogenital warts, b.) Immunocompromised with anogenital warts and c.) Immunocompromised with vulvar HSIL [3:1, active/vehicle]. Eligible subjects may enroll in an (up to) 8-week open-label Part 2 of study
Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 5, 2017
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CLS003
Digoxin and Furosemide topical formulation
Drug: CLS003
CLS003

Placebo Comparator: Vehicle
Inactive vehicle
Drug: Vehicle
Vehicle




Primary Outcome Measures :
  1. Lesion (vulvar HSIL or wart) size reduction [ Time Frame: 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 [ Time Frame: Through study completion, up to 20 weeks ]
  3. HPV viral load assessment [ Time Frame: 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 [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study) ]
  5. Mean HPV viral load [ Time Frame: 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) [ Time Frame: Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study) ]
  7. Local immunity status [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study) ]
  8. Percentage clearance of vulvar HSIL lesions [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study) ]
    For vulvar HSIL cohort

  9. Proportion of patients with all vulvar HSIL lesions cleared [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study) ]
    For vulvar HSIL cohort

  10. Histology (regression of vulvar HSIL to no dysplasia) [ Time Frame: Day 0, 42, 126, (Part 1 of study), Day 56 (Part 2 of study) ]
    For vulvar HSIL cohort

  11. Histological recurrence in the Part 1 follow-up period [ Time Frame: Day 84, 126 ]
    For vulvar HSIL cohort

  12. Percentage clearance of genital warts [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study) ]
    For genital wart cohort

  13. Proportion of patients with all genital warts cleared [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study) ]
    For genital wart cohort

  14. Clinical recurrence in the Part 1 follow-up period [ Time Frame: Day 84, 126 ]
    For genital wart cohort


Secondary Outcome Measures :
  1. Adverse event collection to assess safety/tolerability of CLS003 [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study), and as volunteered by patient ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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
  3. In case of genital warts patient group(s): have at least 3 genital warts (only applicable to Study Part 1)
  4. 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)
  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

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 relevant skin infections in the treatment area other than genital warts (inclusively, but not limited to 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334240


Locations
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Netherlands
LUMC/Centre For Human Drug Research
Leiden, Netherlands
Sponsors and Collaborators
Maruho Co., Ltd.
Investigators
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Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre For Human Drug Research

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Responsible Party: Maruho Co., Ltd.
ClinicalTrials.gov Identifier: NCT03334240     History of Changes
Other Study ID Numbers: CLS003-CO-PR-003
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Maruho Co., Ltd.:
HPV
Digoxin
Furosemide
Vulvar HSIL
Additional relevant MeSH terms:
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Digoxin
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Protective Agents