Joint Outcome Study Continuation for Children With Severe Factor VIII Deficiency (JOSC)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Bayer
Rush University Medical Center
Phoenix Children's Hospital
The University of Texas Health Science Center, Houston
Oregon Health and Science University
Emory University
University of Texas Southwestern Medical Center
Brewer, Erin, PharmD
Indiana University School of Medicine
Intermountain Health Care, Inc.
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01000844
First received: October 22, 2009
Last updated: April 5, 2013
Last verified: October 2010

October 22, 2009
April 5, 2013
November 2009
January 2019   (final data collection date for primary outcome measure)
Determine the natuaral history of joint development in hemophilia and the impact of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic arthropathy. [ Time Frame: Enrollment, age 14, and study exit at age 18 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01000844 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Joint Outcome Study Continuation for Children With Severe Factor VIII Deficiency
Continuation of Children Enrolled in Protocol #95-011, 'A Randomized Prospective Study for the Prevention of Joint Disease in Children With Severe Factor VIII Deficiency'

The original Joint Outcome Study (JOS) enrolled 65 boys with hemophilia from 16 sites nationally. The subjects were randomized to one of two arms (prophylaxis or an enhanced episode-based treatment)and were followed prospectively until the age of six. At the age of six, the proportion of children on each treatment arm who developed bone or cartilage damage as determined by X-Ray or MRI was assessed. In addition, the function and structure of the index joints (defined as knees, ankles, and elbows)were evaluated using a physical assessment scale specially designed for preschool children.

The specific aim of the Joint Outcome Study Continuation (JOSC) is to extend observations of the children participating in the original JOS until the subjects reach the age of 18 years in order to determine the natural history of joint development in hemophilia and the impact of primary or secondary prophylaxis on the prevention, limitation, or reversal of hemophilic arthropathy. In addition, plasma and DNA will be collected and banked yearly for current and future studies of biomarkers and predictors of hemophilia outcomes.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole Blood - EDTA, Citrate Plasma, and DNA

Non-Probability Sample

Study population will be invited based on their enrollment in the original Joint Outcome Study (JOS). This population

Hemophilia
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
January 2020
January 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrolled in the original JOS study, "A Randomized Prospective Study for the Prevention of Joint Disease in Children with Factor VIII Deficiency"
  • Written, informed consent of parent or guardian for the proposed study
  • The local hemophilia treatment center staff must evaluate the family's participation in the original treatment protocol and determine that the family is capable of complying with the continuation protocol

Exclusion Criteria:

  • Unable or unwilling to record the study information
Male
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01000844
01-0436
Yes
University of Colorado, Denver
University of Colorado, Denver
  • Bayer
  • Rush University Medical Center
  • Phoenix Children's Hospital
  • The University of Texas Health Science Center, Houston
  • Oregon Health and Science University
  • Emory University
  • University of Texas Southwestern Medical Center
  • Brewer, Erin, PharmD
  • Indiana University School of Medicine
  • Intermountain Health Care, Inc.
  • Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator: Marilyn Manco-Johnson, MD University of Colorado at Denver Health and Sciences Center
University of Colorado, Denver
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP