SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome (SIMIDIS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00495547|
Recruitment Status : Terminated
First Posted : July 3, 2007
Last Update Posted : April 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome||Drug: Azacitidine Drug: Beta Erythropoietin||Phase 2|
A total of up to 30 patients diagnosed of myelodysplastic syndrome red cell transfusion dependent with low or intermediate -1 risk will be included.
The patients will be evaluated at scheduled visits in up to three study periods: Pre-treatment, Treatment and Follow up.
The Pre-treatment includes Screening and baseline visits. After providing informed consent, patients will be evaluated for study eligibility.
During Treatment Period patients will be evaluated once a month although biochemistry and haematology parameters will be evaluated every 2 weeks.
If an erythroid response after 24 weeks is determined, a extension treatment will be carry out without disease progression.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Non-Randomized, Open-Label Study to Evaluate Efficacy and Safety of Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome Red Cell Transfusion Dependent With Low or Intermediate -1 Risk.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
- Drug: Azacitidine
- Drug: Beta Erythropoietin
- Evaluate the efficacy of the treatment in response rate terms [ Time Frame: 6 months ]
- Evaluate the safety of the treatment [ Time Frame: 2 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00495547
|Hospital Germans Trias i Pujol|
|Hospital Clínic Universitari|
|Hospital del Mar|
|Hospital Reina Sofía|
|Hospital Virgen Blanca|
|Hospital la Paz|
|Hospital Central de Asturias|
|Hospital Son Llatzer|
|Palma de mallorca, Spain|
|Hospital Clinico Universitario|
|Hospital La Fe de Valencia|
|Study Director:||Sanz Guillermo, Dr||Hospital La Fe|
|Study Director:||Del Cañizo Consuelo, DR||Hospital Clinico de Salamanca|