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Subclinical Joint Bleeding in Irish Adults With Severe Haemophilia A on Personalised Prophylaxis Regimens

NCT02314325 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-12-11

No results posted yet for this study

Summary

This trial is designed to assess if there is evidence of subclinical joint bleeding on MRI/X-Ray in adults with severe Haemophilia A while on standard and/or pharmacokinetically tailored prophylaxis regimens. Participants with severe Haemophilia A will have longitudinal MRI and XRay imaging of their elbows, ankles and knees at 0, 6 and 18 months while on standard ( 0-6 months) and then pharmacokinetically tailored (7-18 months) recombinant Factor VIII prophylaxis.

Conditions

  • Severe Haemophilia A

Interventions

DRUG

ADVATE [Antihemophilic Factor (Recombinant)]

In Arm 1 prior patients will be dosed as per body weight 20-40 IU/kg 5-7 infusions per fortnight

DRUG

ADVATE [Antihemophilic Factor (Recombinant)]

In Arm 2 patients who have completed arm 1 will cross over onto an individualised PK tailored alternate day dosing regimen

Sponsors & Collaborators

  • Baxter BioScience

    collaborator INDUSTRY

  • St. James's Hospital, Ireland

    lead OTHER

Principal Investigators

  • Niamh M O'Connell, PhD, FRCPath · St. James's Hospital, Ireland

  • James O'Donnell, PhD, FRCPath · St. James's Hospital, Ireland

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-05-31
Completion
2016-10-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314325 on ClinicalTrials.gov