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Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000586
First Posted: October 28, 1999
Last Update Posted: April 14, 2016
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.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To assess the efficacy and safety of orally administered hydroxyurea in the treatment of painful crises in patients with sickle cell anemia.

Condition Intervention Phase
Anemia, Sickle Cell Hematologic Diseases Hemoglobinopathies Drug: hydroxyurea Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH)

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Occurrence of vaso-occlusive (painful) crisis [ Time Frame: Measured during the first 2 years a patient was enrolled in the study ]

Study Start Date: January 1992
Study Completion Date: June 1994
Primary Completion Date: June 1994 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
Men and women, ages 18 to 50, who had at least three emergency room visits or hospitalizations for sickle cell anemia during the year prior to recruitment. Patients with greater than 20 crises per year were included. A total of 295 patients had Hb ss and four had Hb SB thalassemia.
  Contacts and Locations
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): NCT00000586


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Samuel Charache Johns Hopkins University
Principal Investigator: Michael Terrin Maryland Medical Research Institute
  More Information

Publications:

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: MSH
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

ClinicalTrials.gov Identifier: NCT00000586     History of Changes
Other Study ID Numbers: 306
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: April 14, 2016
Last Verified: January 2009

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hematologic Diseases
Hemoglobinopathies
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors