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Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS

NCT00467610 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-10-24

Study results available
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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)

Conditions

Interventions

DRUG

Panhematin

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Jamile Shammo, MD · Rush University Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00467610 on ClinicalTrials.gov