NCT00207597

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 1995

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1995

Completed
9.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Hemophilia A

Eligibility Criteria

Age1 Year - 30 Months
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • More than 2 bleeds into the same joint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 31115111DERIVED

  • 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.

    PMID: 17687129DERIVED

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marilyn J Manco-Johnson, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
NATURAL HISTORY
Time Perspective
PROSPECTIVE
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

September 1, 1995

Study Completion

August 1, 2005

Last Updated

September 21, 2005

Record last verified: 2005-09