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Therapeutic Effect and Safety of Combined Hydroxyurea With Recombinant Human Erythropoietin.

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: NCT01624038
Recruitment Status : Unknown
Verified June 2012 by Mohsen Saleh Elalfy, Ain Shams University.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Mohsen Saleh Elalfy, Ain Shams University

Study Description
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Brief Summary:

The study hypothesis that treatment with Erythropoietin (EPO) combined with Human Erythropoietin (HUO) therapy will result in hematologic improvement in thalassemia intermedia patients.

Second is to determine whether any of the following correlate with improved hematologic response:

A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels,baseline Erythropoietin levels,baseline hemoglobin levels and baseline reticulocyte counts (or % circulating nucleated erythroblasts/100 WBCs).

Goal:

The aim is to assess the possibility of steady increase of hemoglobin levels in thalassemia intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea and Erythropoietin, growth evaluation,quality of life (QoL) and decline transfusion requirements during study period. Also to report and compare adverse events with other published data regarding.


Condition or disease Intervention/treatment Phase
Thalassemia Intermedia Drug: Hydroxyurea ,Epiao Drug: hydroxyurea, blood transfusion Phase 2 Phase 3

Detailed Description:

To determine whether any of the following correlate with improved hematologic response:

A decrease in hemolysis, as assayed by a decrease in LDH, compared to baseline levels,baseline Erythropoietin levels,baseline hemoglobin level and baseline reticulocyte counts (or % circulating nucleated erythroblasts/100 WBCs).

To assess the possibility of steady increase of hemoglobin levels in thalassemia intermedia patients by at least 1g/dl above baseline levels during therapy using Hydroxyurea and Erythropoietin, growth evaluation , quality of life ( QoL ) and decline transfusion requirements during study period. Also to report and compare adverse events with other published data regarding.

THE following criteria are used when including the patient in the study:

Patients with thalassemia intermedia.Diagnosis based on genetic mutations, hemoglobin electrophoresis and characteristic clinical data at presentation. Patients requiring different transfusion requirements and not transfusion dependent.Patients having a baseline hemoglobin of less than or equal to 6-8g/dl.Patients with normal renal and liver function.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Therapeutic Effect and Safety of Combined Hydroxyurea With Recombinant Human Erythropoietin.
Study Start Date : June 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hydroxyurea,blood transfusion
Hydroxyurea (Myers-Squibb, USA) was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week.
 Drug: hydroxyurea, blood transfusion
  • Hydroxyurea was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week. Hydroxyurea toxicity was defined as a white cell count of less than 2500/μL or a platelet count of less than 100,000/μL, in which case the drug was discontinued.
Experimental: Hydroxyurea, Epiao
  • Hydroxyurea (Myers-Squibb, USA) was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week. Hydroxyurea toxicity was defined as a white cell count of less than 2500/μL or a platelet count of less than 100,000/μL, in which case the drug was discontinued. White cell count and platelet count were determined on a monthly basis. Side effects such as nausea, vomiting, diarrhea, rashes, and malaise, experienced during the first 6 h after taking the HU will be considered as clinical toxicity.
  • Erythropiotien therapy (rHuEPO - Epiao) from 250 to 500 IU/kg rHuEPO subcutaneously three times a week.
 Drug: Hydroxyurea ,Epiao

Hydroxyurea (Myers-Squibb, USA) was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week.

Erythropiotien therapy (rHuEPO - Epiao) from 250 to 500 IU/kg rHuEPO subcutaneously three times a week.


Outcome Measures
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Primary Outcome Measures :
  1. Change in baseline transfusion frequency with increase of pre-transfusion hemoglobin [ Time Frame: baseline and 6 month hemoglobin level and transfusion frequency ]
    Decrease in baseline transfusion frequency with increase of pre-transfusion hemoglobin by calculation of transfusion index and mean hemoglobin level


Secondary Outcome Measures :
  1. Change in baseline quality of life assessment. [ Time Frame: baseline and 6 month QOL questionaire ]
    Quality of life assessment using (QOL questionaire) at the begining and at 6 month


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with thalassemia intermedia. Diagnosis based on genetic mutations, hemoglobin electrophoresis and characteristic clinical data at presentation.
  • Require different transfusion requirements and not transfusion dependent.
  • Have a baseline hemoglobin of less than or equal to 6-8g/dl.
  • Patients with normal renal and liver function.

Exclusion Criteria:

  • Evidence of active hepatitis (ALT > 5 times above ULN).
  • Evidence of renal impairment (serum creatinine > ULN).
  • Patients who are dependent on red blood cell transfusions.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT01624038


Contacts
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Contact: Amira A M Adly, Asst. prof. 0105245837 amiradiabetes@yahoo.com

Locations
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Egypt
hematology clinic ,pediatrics hospital, Ain Shams University hospital
Cairo, Egypt
Principal Investigator: Mohsen Saleh El-Alfy, professor of pediatrics         
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Mohsen S Elalfy, professor Ain Shams University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mohsen Saleh Elalfy, prof. Mohsen el alfy, Ain Shams University
ClinicalTrials.gov Identifier: NCT01624038    
Other Study ID Numbers: huoepio
First Posted: June 20, 2012    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012
Keywords provided by Mohsen Saleh Elalfy, Ain Shams University:
Hydroxyurea
Erythropoitin therapy
Thalassemia intermedia
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
 Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors