Cooperative Study of Factor VIII Inhibitors

NCT00000582 | Completed Phase 3

• 1 other identifier: 302
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of hemophiliac patients who had inhibitors to Factor VIII.

Conditions

Blood Coagulation Disorders; Hematologic Diseases; Hemophilia A; Hemorrhagic Disorders

Interventions

factor ix DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Males with hemophilia, not stratified as to ethnic group.

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 (5)

• Eyster ME, Gill FM, Blatt PM, Hilgartner MW, Ballard JO, Kinney TR. Central nervous system bleeding in hemophiliacs. Blood. 1978 Jun;51(6):1179-88. No abstract available.

  PMID: 647123 BACKGROUND

• Lusher JM, McMillan CW. Severe factor VIII and factor IX deficiency in females. Am J Med. 1978 Oct;65(4):637-48. doi: 10.1016/0002-9343(78)90852-5.

  PMID: 309282 BACKGROUND

• Kasper CK. Effect of prothrombin complex concentrates on factor VIII inhibitor levels. Blood. 1979 Dec;54(6):1358-68.

  PMID: 508942 BACKGROUND

• Lusher JM, Shapiro SS, Palascak JE, Rao AV, Levine PH, Blatt PM. Efficacy of prothrombin-complex concentrates in hemophiliacs with antibodies to factor VIII: a multicenter therapeutic trial. N Engl J Med. 1980 Aug 21;303(8):421-5. doi: 10.1056/NEJM198008213030803.

  PMID: 6771653 BACKGROUND

• Gerety RJ, Eyster ME, Tabor E, Drucker JA, Lusch CJ, Prager D, Rice SA, Bowman HS. Hepatitis B virus, hepatitis A virus and persistently elevated aminotransferases in hemophiliacs. J Med Virol. 1980;6(2):111-8. doi: 10.1002/jmv.1890060203.

  PMID: 6264019 BACKGROUND

MeSH Terms

Conditions

Blood Coagulation Disorders; Hematologic Diseases; Hemophilia A; Hemorrhagic Disorders

Interventions

Factor IX

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Officials

• Louis Aledort

  Icahn School of Medicine at Mount Sinai

• J. Edson

  University of Minnesota

• M. Eyster

  Milton S. Hershey Medical Center

• Scott Goodnight

  University of Oregon Health Sciences Center

• William Hathaway

  University of Colorado Medical Center

• Jack Lazerson

  Milwaukee Children's Hospital

• Peter Levine

  Memorial hospital

• Jeanne Lusher

  Wayne State University

• Campbell McMillan

  University of North Carolina

• Sandor Shapiro

  Thomas Jefferson University

Study Design

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

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: July 1, 1978
• Study Completion: July 1, 1979
• Last Updated: April 27, 2012

Record last verified: 2012-04