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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: Clinical Trial Phase 2 study, sponsored by Rush University Medical Center.

NCT00467610 is a Phase 2 study that was terminated before completion, run by Rush University Medical Center. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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)

Primary Outcome

Number of patients with no adverse events.

Interventions

  • DRUG Panhematin

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2007-05
Est. Completion 2009-01
Phase Phase 2
Rush University Medical Center

320 total trials

Why NCT00467610 stopped before completion

NCT00467610 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 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Panhematin is the first listed.

NCT00467610 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00467610's enrollment target sits among peer trials

6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00467610, the US trial registry maintained by the National Library of Medicine. NCT00467610 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.