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NCT01816646 · ClinicalTrials.gov registry record · Phase 1
Intravesical Cidofovir for Hemorrhagic Cystitis
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT01816646: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01816646 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 6 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01816646, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose directly into the bladder is absorbed by the body. Researchers also want to measure the amount of study drug in the body at different time points. The safety and tolerability of this drug will also be studied. Cidofovir is designed to fight certain viruses by blocking the virus cells from dividing.
Primary Outcome
Systemic absorption of drug evaluated during and after intravesical administration. Blood collected for each sample in the following schedule: 1. T0 (pre-instillation) 2. 1 hour (after instillation) 3. 2 hours (after instillation-at the time of de-clamping) 4. 4 hours +/- 1 hour (after instillation) 5. 14 hours +/- 1 hour (14 hours after instillation or 12 hours from de-clamping). 6. 24 hours +/- 1 hour after instillation to ensure complete characterization of cidofovir elimination.
Interventions
- DRUG Probenecid
- DRUG Cidofovir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT01816646 record still lists
NCT01816646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Probenecid is the first listed.
NCT01816646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01816646 about?
NCT01816646 is a clinical study titled "Intravesical Cidofovir for Hemorrhagic Cystitis". The goal of this clinical research study is to learn how the drug cidofovir given as 1 dose directly into the bladder is absorbed by the body. Researchers also want to measure the amount of study drug in the body at different time points. The safety and tolerability of this drug will also be studied...
What is the current status of trial NCT01816646?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2013-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01816646?
The interventions under investigation include: Probenecid (DRUG), Cidofovir (DRUG).
Who is sponsoring clinical trial NCT01816646?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01816646's enrollment target sits among peer trials
6 1974th of 2000 higher than 12 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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