Evaluation of safety following Immune Tolerance Induction treatment with turoctocog alfa in patients with haemophilia A following inhibitor development in NN7170-4213 trial
- Conditions
- Haemophilia AMedDRA version: 20.0 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2016-003821-40-DE
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 6
- Previous participation in the NN7170-4213 trial (male, age = 18 years (part A) and age = 12 years (part B)).
- Development of a confirmed high titre neutralising antibody towards factor VIII (>5 Bethesda Unit) after exposure to subcutaneous turoctocog alfa pegol in the NN7170- 4213 trial or development of a confirmed clinically relevant low titre inhibitor (=0.6 to =5 Bethesda Unit), defined as factor VIII activity measures (recovery) and/or bleed pattern indicating a lack of clinical response to factor VIII treatment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Known or suspected hypersensitivity to trial product(s) or related products, defined as allergic reactions.
- Participation in another clinical trial within 1 month before screening (except participation in NN7170-4213).
- Any disorder, except for conditions associated with Haemophilia A which in the investigator’s opinion might jeopardise patients’ safety or compliance with the protocol.
- Currently receiving immune tolerance induction treatment with a factor VIII containing
product other than turoctocog alfa.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate safety of immune tolerance induction treatment with turoctocog alfa in patients who have developed neutralising antibodies against factor VIII after exposure to subcutaneous turoctocog alfa pegol during participation in NN7170-4213;Secondary Objective: To evaluate efficacy of immune tolerance induction treatment with turoctocog alfa;Primary end point(s): Number of adverse events;Timepoint(s) of evaluation of this end point: During immune tolerance induction treatment with turoctocog alfa.
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Response to immune tolerance induction treatment (success, partial success, failure,<br> other)<br> ;Timepoint(s) of evaluation of this end point: Within a maximum immune tolerance induction treatment duration of 24 months.