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NCT01295645 · ClinicalTrials.gov registry record · Phase 2
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
A Phase 2 study of Transplantation Infection, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT01295645: Active Phase 2 study of Transplantation Infection, sponsored by M.D. Anderson Cancer Center.
NCT01295645 is a Phase 2 study of Transplantation Infection that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 27 participants, below the 290-participant average among 4 other Transplantation Infection trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01295645, a Phase 2 study of Transplantation Infection, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Response defined as improvement in symptoms based on questionnaire, reduction or stability in grade of hemorrhagic cystitis, and level of virus must be a 1 log reduction from baseline when the BKV was first diagnosed.
Conditions Studied
Interventions
- DRUG Cidofovir
- OTHER No Cidofovir
Study Locations (1)
Texas
- University of Texas MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2011-03-17 |
| Est. Completion | 2028-03-15 |
| Phase | Phase 2 |
What the registry record for NCT01295645 still lists
NCT01295645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 290-participant average among 4 other Transplantation Infection trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Transplantation Infection appearing as the primary indexed condition, and to 2 interventions - of which Cidofovir is the first listed.
NCT01295645 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01295645 about?
NCT01295645 is a clinical study titled "Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis". 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.
What is the current status of trial NCT01295645?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2011-03-17. Estimated completion is 2028-03-15.
What conditions does trial NCT01295645 study?
This clinical trial studies the following conditions: Transplantation Infection.
What interventions are being tested in trial NCT01295645?
The interventions under investigation include: Cidofovir (DRUG), No Cidofovir (OTHER).
Who is sponsoring clinical trial NCT01295645?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01295645 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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