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Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.

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ClinicalTrials.gov Identifier: NCT02567149
Recruitment Status : Withdrawn (No funding)
First Posted : October 2, 2015
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE September 30, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date July 2, 2017
Study Start Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • Clinical resolution of treated warts as evaluated by the investigators [ Time Frame: 6 months ]
    Total or near-total clinical resolution of treated warts as evaluated by the investigators
  • Improvement of wart-associated symptoms [ Time Frame: 6 months ]
    2. Patient-perceived improvement of wart-associated symptoms
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Patient/parent reported tolerability of the treatment [ Time Frame: 6 months ]
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 Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.
Official Title  ICMJE Intralesional Cidofovir for the Treatment of Recalcitrant Warts in the Pediatric Immune-suppressed Population.
Brief Summary

The primary objective is to determine whether intralesional cidofovir is effective at bringing about the total or near-total resolution of warts that have already proven recalcitrant to standard therapy.

The secondary objective is to determine the tolerability of this new mode of administration of cidofovir in the pediatric population

Detailed Description This study includes pediatric patients with history of either primary or iatrogenic immune-suppression who are seeking treatment of warts that have already proven recalcitrant to standard therapy. The first cohort will include 4 patients ages 12 to 17. After all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Warts
Intervention  ICMJE Drug: Cidofovir
Cidofovir
Study Arms  ICMJE Experimental: Cidofovir
Cidofovir clinical resolution of treated warts as evaluated by the investigators
Intervention: Drug: Cidofovir
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 Withdrawn
Actual Enrollment  ICMJE
 (submitted: June 28, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
10
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. The first cohort will include a total of 4 patients ages 12 to 17. After all tests indicate treatment safety, the second cohort will be recruited and will include patients ages 8 to 17.Patient is in immune-suppressed status by one of the following:

    1. Primary immunodeficiency, which may include but is not limited to the following:

      1. Chronic Granulomatous Disease (CGD)
      2. Common Variable Immunodeficiency (CVID)
      3. DiGeorge Syndrome (DGS)
      4. Selective IgA Deficiency
      5. Severe Combined Immunodeficiency (SCID)
      6. X-Linked Agammaglobulinemia (XLA)
    2. Pharmacologic immune-suppressed status from medications including but not limited to:

      1. prednisone
      2. cyclosporine
      3. azathioprine
      4. tacrolimus/ FK506
      5. mycophenolate mofetil
      6. sirolimus

      2. Patient has history of clinically-significant warts that are either refractory to standard therapy or for which standard therapy is contra-indicated or unreasonable 3. Patient has a total wart burden of at least 1cm 4. Patients must have tried and failed at least 2 other conventional treatments for cutaneous warts, including but not limited to:

      • cryotherapy
      • topical salicylic acid
      • imiquimod
      • topical 5FU
      • pulsed dye laser therapy
      • sinecatechins
      • tretinoin or other topical retinoid
      • intralesional candida injection
      • bleomycin
      • electrocautery
      • topical cidofovir cream or gel

      There will be a one month washout period for all treatment modalities, with the exception of intralesional candida, which will be 3 months.

      5. Patient desires ongoing treatment of their warts 6. Patient and/or their parent/guardian consents to participating in this study

      Exclusion Criteria:

    1. Treatment area is either ulcerated, secondarily infected, or significantly inflamed
    2. Treatment area is on face or groin area
    3. Patient is pregnant, attempting to become pregnant, or lactating
    4. Patient reports active kidney disease, or chart review reveals recent serum creatinine ≥1.5mg/dL or a history of renal disease/insufficiency or history of diabetes
    5. Patient is currently receiving a nephrotoxic medication
    6. Patient has history of hypersensitivity to cidofovir
    7. Patient is severely ill and/or hospitalized
    8. Patient is receiving chemotherapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02567149
Other Study ID Numbers  ICMJE Version 1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ingrid Polcari, MD University of Minnesota
PRS Account University of Minnesota
Verification Date June 2017

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