Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH) - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000586

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Multicenter Study of Hydroxyurea in Patients With Sickle Cell Anemia (MSH)

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia

Drug Information available for: Hydroxyurea

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Charache S, Dover GJ, Moore RD, Eckert S, Ballas SK, Koshy M, Milner PF, Orringer EP, Phillips G Jr, Platt OS, et al. Hydroxyurea: effects on hemoglobin F production in patients with sickle cell anemia. Blood. 1992 May 15;79(10):2555-65.

Lu ZH, Steinberg MH. Fetal hemoglobin in sickle cell anemia: relation to regulatory sequences cis to the beta-globin gene. Multicenter Study of Hydroxyurea. Blood. 1996 Feb 15;87(4):1604-11.

Charache S, Terrin ML, Moore RD, Dover GJ, Barton FB, Eckert SV, McMahon RP, Bonds DR. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. N Engl J Med. 1995 May 18;332(20):1317-22.

Charache S, Terrin ML, Moore RD, Dover GJ, McMahon RP, Barton FB, Waclawiw M, Eckert SV. Design of the multicenter study of hydroxyurea in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea. Control Clin Trials. 1995 Dec;16(6):432-46.

Charache S, Barton FB, Moore RD, Terrin ML, Steinberg MH, Dover GJ, Ballas SK, McMahon RP, Castro O, Orringer EP. Hydroxyurea and sickle cell anemia. Clinical utility of a myelosuppressive "switching" agent. The Multicenter Study of Hydroxyurea in Sickle Cell Anemia. Medicine (Baltimore). 1996 Nov;75(6):300-26.

Hackney AC, Hezier W, Gulledge TP, Jones S, Strayhorn D, Busby M, Hoffman E, Orringer EP. Effects of hydroxyurea administration on the body weight, body composition and exercise performance of patients with sickle-cell anaemia. Clin Sci (Lond). 1997 May;92(5):481-6.

Steinberg MH, Lu ZH, Barton FB, Terrin ML, Charache S, Dover GJ. Fetal hemoglobin in sickle cell anemia: determinants of response to hydroxyurea. Multicenter Study of Hydroxyurea. Blood. 1997 Feb 1;89(3):1078-88.

Charache S. Mechanism of action of hydroxyurea in the management of sickle cell anemia in adults. Semin Hematol. 1997 Jul;34(3 Suppl 3):15-21. Review.

McMahon RP, Waclawiw MA, Geller NL, Barton FB, Terrin ML, Bonds DR. An extension of stochastic curtailment for incompletely reported and classified recurrent events: the Multicenter Study of Hydroxyurea in Sickle Cell Anemia (MSH). Control Clin Trials. 1997 Oct;18(5):420-30.

Charache S, Barton FB, Moore RD, Terrin ML, Steinberg MH, Dover GJ, Ballas SK, McMahon RP, Castro O, Orringer EP. Hydroxyurea and sickle cell anemia. Clinical utility of a myelosuppressive "switching" agent. The Multicenter Study of Hydroxyurea in Sickle Cell Anemia. Medicine (Baltimore). 1996 Nov;75(6):300-26.

Moore RD, Charache S, Terrin ML, Barton FB, Ballas SK. Cost-effectiveness of hydroxyurea in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. Am J Hematol. 2000 May;64(1):26-31.

Steinberg MH, Barton F, Castro O, Pegelow CH, Ballas SK, Kutlar A, Orringer E, Bellevue R, Olivieri N, Eckman J, Varma M, Ramirez G, Adler B, Smith W, Carlos T, Ataga K, DeCastro L, Bigelow C, Saunthararajah Y, Telfer M, Vichinsky E, Claster S, Shurin S, Bridges K, Waclawiw M, Bonds D, Terrin M. Effect of hydroxyurea on mortality and morbidity in adult sickle cell anemia: risks and benefits up to 9 years of treatment. JAMA. 2003 Apr 2;289(13):1645-51.

Study ID Numbers:	306
Study First Received:	October 27, 1999
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00000586 History of Changes
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hydroxyurea
Hematologic Diseases
Hemoglobinopathies

Anemia
Sickle Cell Anemia
Anemia, Hemolytic
Hemoglobinopathy
Anemia, Sickle Cell

Additional relevant MeSH terms:

Antisickling Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Diseases
Hydroxyurea
Antineoplastic Agents
Hematologic Agents
Anemia
Anemia, Hemolytic

Enzyme Inhibitors
Pharmacologic Actions
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hemoglobinopathies
Therapeutic Uses
Anemia, Sickle Cell
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 06, 2009