Joint Outcome Study Continuation for Children With Severe Factor VIII Deficiency (JOSC)
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Purpose
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.
| Condition |
|---|
|
Hemophilia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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' |
- 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 ]
Biospecimen Retention: Samples With DNA
Whole Blood - EDTA, Citrate Plasma, and DNA
| Estimated Enrollment: | 50 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | January 2020 |
| Estimated Primary Completion Date: | January 2019 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 8 Years to 18 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study population will be invited based on their enrollment in the original Joint Outcome Study (JOS). This population
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
Contacts and Locations| Principal Investigator: | Marilyn Manco-Johnson, MD | University of Colorado at Denver Health and Sciences Center |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT01000844 History of Changes |
| Other Study ID Numbers: | 01-0436 |
| Study First Received: | October 22, 2009 |
| Last Updated: | April 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
Hemophilia Joint Cartilage Damage Prophylaxis |
Factor VIII FVIII Disease Arthropathy |
Additional relevant MeSH terms:
|
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders |
Genetic Diseases, Inborn Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013