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NCT00467610 · ClinicalTrials.gov registry record · Phase 2
Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS
A Phase 2 study, sponsored by Rush University Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT00467610 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 6 participants.
The verdict
NCT00467610, a Phase 2 study, was terminated before completion, sponsored by Rush University Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a Phase II, open-label clinical trial examining the role of Panhematin® in patients with MDS. The objective of this study is to evaluate the safety and efficacy of Panhematin® (hematin for injection) in the treatment of adult patients (≥ 18 years of age) with low-risk MDS. The study will be conducted on an outpatient basis and will consist of the following: * A Screening Period (within 28 days of the Day 1) * Screening bone marrow aspiration and biopsy up to 60 days prior to receiving study medication * An 8-week Treatment Period (Days 1 through 4 of Week 1, and weekly visits during Weeks 2 through 8); partial and complete responders in any of the three cell lines may continue treatment for an additional 4 weeks * A 6-month Post treatment Follow-up Period (monthly clinic visits during Weeks 12 40)
Interventions
- DRUG Panhematin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2007-05 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00467610
The ClinicalTrials.gov registry entry for NCT00467610 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Panhematin is the first listed.
NCT00467610 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00467610 about?
NCT00467610 is a clinical study titled "Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS". This is a Phase II, open-label clinical trial examining the role of Panhematin® in patients with MDS. The objective of this study is to evaluate the safety and efficacy of Panhematin® (hematin for injection) in the treatment of adult patients (≥ 18 years of age) with low-risk MDS. The study will be...
What is the current status of trial NCT00467610?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2007-05. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00467610?
The interventions under investigation include: Panhematin (DRUG).
Who is sponsoring clinical trial NCT00467610?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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