Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS
Status:
Terminated
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
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)