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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03946384
Other study ID # BOVET 2019
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2019
Est. completion date October 2019

Study information

Verified date May 2019
Source Centre Hospitalier Universitaire Dijon
Contact Julien BOVET
Phone 3.80.29.33.14
Email julien.bovet@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It appears that the mutation p.Ile112Thr in the factor IX gene confers a discrepancy between mild factor IX level and severe bleeding phenotype. Databases and litterature analysis are poor on this matter. The goal of this study is to compile bleeding phenotype in patients with this specific mutation to prove the clinico-biological discordance in order to improve patient care and follow-up.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date October 2019
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- hemophilia B with p.Ile112Thr mutation on factor IX gene

Exclusion Criteria: None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
data collection
data collection on the history of the disease, hemophilia

Locations

Country Name City State
France CHU Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bleeding phenotype bleeding phenotype in patients with p.Ile112Thr in factor IX gene Through study completion, an average of 4 months
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