Joint Outcome Study Continuation for Children With Severe Factor VIII Deficiency

Hemophilia Clinical Trial

— JOSC  

Official title:

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'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000844
• Other study ID #: 01-436
• Status: Completed
• Start date: November 2009
• Est. completion date: October 2017

Study information

• Verified date: October 2019
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia
• Hemophilia A

Locations

Country	Name	City	State
n/a

Sponsors (12)

Lead Sponsor	Collaborator
University of Colorado, Denver	Ann & Robert H Lurie Children's Hospital of Chicago, Bayer, Emory University, Indiana University School of Medicine, Intermountain Health Care, Inc., Oregon Health and Science University, Phoenix Children's Hospital, Prisma Health-Midlands, Rush University Medical Center, The University of Texas Health Science Center, Houston, University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Enrollment, age 14, and study exit at age 18