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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 7, 2017
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE October 5, 2017
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • 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) ]
  • Change in patient-reported outcomes [ Time Frame: Through study completion, up to 20 weeks ]
  • 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) ]
  • 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) ]
  • 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) ]
  • 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) ]
  • Local immunity status [ Time Frame: Day 0, 21, 42, 84, 126, (Part 1 of study), Day 0, 28, 56, 140 (Part 2 of study) ]
  • 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
  • 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
  • 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
  • Histological recurrence in the Part 1 follow-up period [ Time Frame: Day 84, 126 ]
    For vulvar HSIL cohort
  • 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
  • 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
  • Clinical recurrence in the Part 1 follow-up period [ Time Frame: Day 84, 126 ]
    For genital wart cohort
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ICVT in HPV-induced Genital Lesions of Immunocompromised and Immunocompetent Patients
Official Title  ICMJE 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
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE HPV-Induced Genital Lesions
Intervention  ICMJE
  • Drug: CLS003
    CLS003
  • Drug: Vehicle
    Vehicle
Study Arms  ICMJE
  • Experimental: CLS003
    Digoxin and Furosemide topical formulation
    Intervention: Drug: CLS003
  • Placebo Comparator: Vehicle
    Inactive vehicle
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 18, 2019)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
48
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date October 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03334240
Other Study ID Numbers  ICMJE CLS003-CO-PR-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maruho Co., Ltd.
Study Sponsor  ICMJE Maruho Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J. (Koos) Burggraaf, MD, PhD Centre For Human Drug Research
PRS Account Maruho Co., Ltd.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP