Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS
Terminated
H. Lundbeck A/S
Phase 2
2007-05-01
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)
Phase 2, Open-Label, Multi-Dose Study of Panhematin in Patients With MDS
Terminated
Rush University Medical Center
Phase 2
2007-05-01
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)
This study is being done because we want to learn if hemin can increase the production of
heme oxygenase 1. Heme oxygenase 1 (HO-1) is an enzyme which protects cells from physical,
chemical, and biologic stress. Hemin is produced from red blood cells and is approved by the
Food and Drug Administration for treating acute porphyria, which is an inherited condition
caused by an enzyme deficiency.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models.
By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
