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Stop study.


- candidate number10428
- NTR NumberNTR3098
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-okt-2011
- Secondary IDsU1111-1121-7069 WHO UTN
- Public TitleStop study.
- Scientific TitleSevere Haemophilia: Prophylactic treatment in the 2nd and 3rd decade.
- ACRONYM
- hypothesisIs there a group of severe haemophilia patients that can reduce or stop prophylaxis in their 2nd and 3rd decade without an increased risk of bleeding and joint damage?
- Healt Condition(s) or Problem(s) studiedCompliance, Haemophilia, Bleeding, Prophylaxis, Arthropathy
- Inclusion criteria1. Severe haemophilia A (factor VIII < 0.01 IU/ml);
2. Born between January 1st 1970 and January 1st 1988;
3. Registered at the haemophilia treatment centres in Utrecht (NL), Århus and Copenhagen (DK).
- Exclusion criteria1. History of inhibitory activity of more than 5 BU at any time or less than 5 BU for more than one year;
2. Inadequate access to treatment during the first years of life (i.e. no access to unlimited replacement therapy during the first 4 years of life, e.g. in case of immigration);
3. Insufficient follow up or insufficient data;
4. Other pathology influencing bleeding pattern.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-nov-2011
- planned closingdate1-nov-2014
- Target number of participants90
- InterventionsN/A
- Primary outcome1. Joint status according to Haemophilia Joint Health Score (HJHS) and Pettersson score;
2. Annual number of joint bleeds;
3. Figure 8 walk test.
- Secondary outcome1. Clotting factor consumption;
2. Orthopaedic surgery;
3. Hospital admissions in the third decade of life;
4. Major soft tissue bleeds.
- TimepointsRetrospective collection of treatment history and cross-sectional assessment of outcome measured from 2011 until 2013.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Kathelijn Fischer
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Kathelijn Fischer
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
Novo Nordisk
- PublicationsN/A
- Brief summaryPrimary prophylaxis was designed as a life-long replacement therapy to prevent bleeds and maintain joint function in patients with severe haemophilia. Maintaining this treatment is a heavy burden for the patient, and treatment is likely to include periods of reduced adherence. Information on the consequences of tapering or discontinuing prophylaxis, and knowledge of which patients may try this without taking irresponsible risks is vital in the support of this life-long treatment.
The present project will assess patient-initiated changes in long-term prophylaxis in the second and third decade. By measuring outcome, safety of discontinuing or tapering prophylaxis, will be assessed. Additionally a prognostic model aims to identify clinical parameters as predictors of successful discontinuation and tapering.
This information will provide an evidence base for day-to-day issues in treating young adults with severe haemophilia, help to individualise prophylactic treatment, as well as increase cost-effectiveness of prophylaxis.
- Main changes (audit trail)
- RECORD10-okt-2011 - 26-okt-2011


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