Joint Outcome Study

NCT ID: NCT00207597

Last Updated: 2005-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

1995-09-30

Study Completion Date

2005-08-31

Brief Summary

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This study examines the progression of joint disease in children with hemophilia assigned to either standard treatment or enhanced therapy.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

NATURAL_HISTORY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with hemophilia A
* factor level less than 2%

Exclusion Criteria

* More than 2 bleeds into the same joint
Minimum Eligible Age

1 Year

Maximum Eligible Age

30 Months

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role lead

Principal Investigators

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Marilyn J Manco-Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

References

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Warren BB, Jacobson L, Kempton C, Buchanan GR, Recht M, Brown D, Leissinger C, Shapiro AD, Abshire TC, Manco-Johnson MJ; Joint Outcome Study Group Investigators. Factor VIII prophylaxis effects outweigh other hemostasis contributors in predicting severe haemophilia A joint outcomes. Haemophilia. 2019 Sep;25(5):867-875. doi: 10.1111/hae.13778. Epub 2019 May 21.

Reference Type DERIVED
PMID: 31115111 (View on PubMed)

Manco-Johnson MJ, Abshire TC, Shapiro AD, Riske B, Hacker MR, Kilcoyne R, Ingram JD, Manco-Johnson ML, Funk S, Jacobson L, Valentino LA, Hoots WK, Buchanan GR, DiMichele D, Recht M, Brown D, Leissinger C, Bleak S, Cohen A, Mathew P, Matsunaga A, Medeiros D, Nugent D, Thomas GA, Thompson AA, McRedmond K, Soucie JM, Austin H, Evatt BL. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007 Aug 9;357(6):535-44. doi: 10.1056/NEJMoa067659.

Reference Type DERIVED
PMID: 17687129 (View on PubMed)

Other Identifiers

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U27/CCU812106

Identifier Type: -

Identifier Source: secondary_id

CDC-NCBDDD-1455

Identifier Type: -

Identifier Source: org_study_id