CompletedNot Applicable

rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A

France, Germany44 participantsStarted 2018-11-07

Plain-language summary

A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients diagnosed with haemophilia A who have been, or who are currently, treated with rFVIIIFc for ITI. * Signed and dated informed consent provided by the patient, or the patient's legally acceptable representative for patients under the legal age, before any study-related data collection are undertaken. Assent should be obtained from paediatric patients according to local regulations. Exclusion Criteria: * Current participation in any investigational medicinal product trial.

What they're measuring

ITI with rFVIIIFc: Main dose

Timeframe: From 2018 to 2022

ITI with rFVIIIFc: Main injection frequency

Timeframe: From 2018 to 2022

ITI with rFVIIIFc: Duration

Timeframe: From 2018 to 2022

ITI with rFVIIIFc: Concomitant by-passing agents

Timeframe: From 2018 to 2022

Outcome of ITI with rFVIIIFc: Overall outcome

Timeframe: From 2018 to 2022

Outcome of ITI with rFVIIIFc: Time to undetectable inhibitor titer

Timeframe: From 2018 to 2022

Outcome of ITI with rFVIIIFc: Time to normal recovery

Timeframe: From 2018 to 2022

Outcome of ITI with rFVIIIFc: Time to success

Timeframe: From 2018 to 2022

Trial details

NCT IDNCT03951103

SponsorSwedish Orphan Biovitrum

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Hemophilia A With Inhibitor trials