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

NCT00000586 | Completed Phase 3

• 1 other identifier: 306
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To assess the efficacy and safety of orally administered hydroxyurea in the treatment of painful crises in patients with sickle cell anemia.

Conditions

Anemia, Sickle Cell; Hematologic Diseases; Hemoglobinopathies

Outcome Measures

Primary Outcomes (1)

• Occurrence of vaso-occlusive (painful) crisis

  Measured during the first 2 years a patient was enrolled in the study

Interventions

hydroxyurea DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Related Publications (11)

• 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.

  PMID: 1375104 BACKGROUND

• 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.

  PMID: 8608254 BACKGROUND

• 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. doi: 10.1056/NEJM199505183322001.

  PMID: 7715639 BACKGROUND

• 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. doi: 10.1016/s0197-2456(95)00098-4.

  PMID: 8925656 BACKGROUND

• 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. doi: 10.1042/cs0920481.

  PMID: 9176021 BACKGROUND

• 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.

  PMID: 9028341 BACKGROUND

• 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.

  PMID: 9317197 BACKGROUND

• 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. doi: 10.1016/s0197-2456(97)00014-7.

  PMID: 9315425 BACKGROUND

• 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. doi: 10.1002/(sici)1096-8652(200005)64:13.0.co;2-f.

  PMID: 10815784 BACKGROUND

• 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. doi: 10.1001/jama.289.13.1645.

  PMID: 12672732 BACKGROUND

• 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. doi: 10.1097/00005792-199611000-00002.

  PMID: 8982148 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell; Hematologic Diseases; Hemoglobinopathies

Interventions

Hydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals

Study Officials

• Samuel Charache

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Michael Terrin

  Maryland Medical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: January 1, 1992
• Primary Completion: June 1, 1994
• Study Completion: June 1, 1994
• Last Updated: April 14, 2016

Record last verified: 2009-01