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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03623295




Registration number
NCT03623295
Ethics application status
Date submitted
6/08/2018
Date registered
9/08/2018

Titles & IDs
Public title
The Dynamic Interplay Between Bleeding Phenotype and Baseline Factor Level in Moderate and Mild Hemophilia A and B
Scientific title
The Dynamic Interplay Between Bleeding Phenotype and Baseline Factor Level in Moderate and Mild Hemophilia A and B
Secondary ID [1] 0 0
NL61564.018.17
Universal Trial Number (UTN)
Trial acronym
DYNAMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemophilia 0 0
Condition category
Condition code
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Blood sample
Other interventions - Questionnaire
Other interventions - MRI-imaging
Other interventions - Physical examination

Cohort study population - For the main cohort study, we will include 500 patients with moderate or mild hemophilia A and 500 patients with moderate or mild hemophilia B.

Sub study population - A subset of 200 patients of the cohort study population will be investigated in more detail by longitudinal data collection.


Other interventions: Blood sample
Blood withdrawal.

Other interventions: Questionnaire
Online questionnaire about the bleeds that patients experienced in the past.

Other interventions: MRI-imaging
MRI imaging of joints.

Other interventions: Physical examination
Physical examination of joint status.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bleeding phenotype
Timepoint [1] 0 0
Retrospective 10 years

Eligibility
Key inclusion criteria
* Moderate or mild hemophilia A (FVIII:C 0.02-0.35 IU/mL) or hemophilia B (FIX:C 0.02-0.35 IU/mL)
* Age from 12 up to and including 55 years
Minimum age
12 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Other clotting disorder
* Participation in another trial with an investigational product
* Comorbidity affecting the musculoskeletal status
* Clinically relevant inhibitor status at present or in the past
* Hemophilia B Leyden
* Use of anticoagulants

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2022
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Multiple Locations
Country [3] 0 0
Canada
State/province [3] 0 0
Multiple Locations
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
Germany
State/province [5] 0 0
Multiple Locations
Country [6] 0 0
Italy
State/province [6] 0 0
Multiple Locations
Country [7] 0 0
Netherlands
State/province [7] 0 0
Amsterdam
Country [8] 0 0
Netherlands
State/province [8] 0 0
Groningen
Country [9] 0 0
Netherlands
State/province [9] 0 0
Leiden
Country [10] 0 0
Netherlands
State/province [10] 0 0
Maastricht
Country [11] 0 0
Netherlands
State/province [11] 0 0
Nijmegen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Rotterdam
Country [13] 0 0
Netherlands
State/province [13] 0 0
Utrecht
Country [14] 0 0
Netherlands
State/province [14] 0 0
Veldhoven
Country [15] 0 0
Spain
State/province [15] 0 0
Multiple Locations
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Multiple Locations

Funding & Sponsors
Primary sponsor type
Other
Name
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Karin Fijnvandraat
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne-Fleur Zwagemaker
Address 0 0
Country 0 0
Phone 0 0
+31205668668
Fax 0 0
Email 0 0
a.zwagemaker@amc.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03623295