Active — Not RecruitingPhase 2

Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis

United States27 participantsStarted 2011-03-17

Plain-language summary

The goal of this clinical research study is to learn if adding cidofovir to the standard of care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to standard of care alone. The safety of cidofovir will also be studied.

Who can participate

Age range6 Years

SexALL

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Inclusion criteria

✓. HSCT patients with symptomatic hemorrhagic cystitis (minimal Grade 1 symptoms of HC per NCI criteria) and positive BKV in urine \>1x103 DNA copies/ml
✓. Age \>/= 6 years
✓. Patient must sign the informed consent document.

Exclusion criteria

✕. Creatine clearance \< 55 ml/min, calculated using ideal body weight (IBW) using Cockcroft-Gault equation
✕. Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
✕. Use of cidofovir for bladder instillation
✕. Use of formalin or hyperbaric oxygen treatment

What they're measuring

Number of Patients with Microbiologic Response

Timeframe: 8 weeks

Trial details

NCT IDNCT01295645

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-15

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