SIMIDIS: Azacitidine and Beta Erythropoietin Treatment in Patients With Myelodysplastic Syndrome (SIMIDIS)
|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 ]
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|