Hemophilia ANCT00207597
Joint Outcome Study
An observational study of Hemophilia A, run by Centers for Disease Control and Prevention.
Trial summary
This study examines the progression of joint disease in children with hemophilia assigned to either standard treatment or enhanced therapy. Read more about this study
- Who is it for?
- Ages 1 year to 30 months, men only
- Conditions the study is for
- Hemophilia A
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Sep 1995to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with hemophilia A
- factor level less than 2%
Who cannot join
- More than 2 bleeds into the same joint
About this study
Official title: A Clinical Trial of Primary Prophylaxis Against Joint Disease in Children With Severe Hemophilia
This study examines the progression of joint disease in children with hemophilia assigned to either standard treatment or enhanced therapy.
- Conditions
- Hemophilia A
- Medical subject headings
- Hemophilia A
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 1995
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Natural history
- Time perspective
- Prospective
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Investigators
- Marilyn J Manco-Johnson, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207597
- Sponsor's protocol ID
- CDC-NCBDDD-1455
- Other IDs
- U27/CCU812106
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Publications
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.
PubMed 31115111Manco-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.
PubMed 17687129
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of Primary Prophylaxis Against Joint Disease in Children With Severe Hemophilia
- ClinicalTrials.gov ID
- NCT00207597
- Acronym / sponsor ID
- CDC-NCBDDD-1455
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Sep 1995
- Study completion
- Aug 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the progression of joint disease in children with hemophilia assigned to either standard treatment or enhanced therapy.
Study design
- Observational model
- Natural history
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 30 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with hemophilia A
- factor level less than 2%
Key exclusion criteria (1 listed)
- More than 2 bleeds into the same joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
- Derived from this study: PubMed 31115111Warren 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.
- Derived from this study: PubMed 17687129Manco-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn J Manco-Johnson, MD principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Centers for Disease Control and Prevention.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00207597, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2005.