Evaluation of safety following Immune Tolerance Induction treatment with turoctocog alfa in patients with haemophilia A following inhibitor development in NN7170-4213 trial

Phase 1

• Conditions: Haemophilia A; MedDRA version: 19.1Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2016-003821-40-BG
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-14
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 9

Inclusion Criteria

- 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: 4
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

Exclusion Criteria

- 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