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

NCT02567149 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: Version 1.0
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Warts

Keywords

Wart

Outcome Measures

Primary Outcomes (2)

• Clinical resolution of treated warts as evaluated by the investigators

  Total or near-total clinical resolution of treated warts as evaluated by the investigators

  6 months

• Improvement of wart-associated symptoms

  2\. Patient-perceived improvement of wart-associated symptoms

  6 months

Secondary Outcomes (1)

• Patient/parent reported tolerability of the treatment

  6 months

Study Arms (1)

Cidofovir

EXPERIMENTAL

Cidofovir clinical resolution of treated warts as evaluated by the investigators

Drug: Cidofovir

Interventions

Cidofovir DRUG

Cidofovir

Cidofovir

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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:
• Primary immunodeficiency, which may include but is not limited to the following:
• Chronic Granulomatous Disease (CGD)
• Common Variable Immunodeficiency (CVID)
• DiGeorge Syndrome (DGS)
• Selective IgA Deficiency
• Severe Combined Immunodeficiency (SCID)
• X-Linked Agammaglobulinemia (XLA)
• Pharmacologic immune-suppressed status from medications including but not limited to:
• prednisone
• cyclosporine
• azathioprine
• tacrolimus/ FK506
• mycophenolate mofetil
• sirolimus

You may not qualify if:

• <!-- -->
• Treatment area is either ulcerated, secondarily infected, or significantly inflamed
• Treatment area is on face or groin area
• Patient is pregnant, attempting to become pregnant, or lactating
• 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
• Patient is currently receiving a nephrotoxic medication
• Patient has history of hypersensitivity to cidofovir
• Patient is severely ill and/or hospitalized
• Patient is receiving chemotherapy

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Warts

Interventions

Cidofovir

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ingrid Polcari, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2015
• First Posted: October 2, 2015
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)