Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients with Haemophilia A

• Conditions: Haemophilia A; MedDRA version: 12.1Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)

• Registration Number: EUCTR2010-023921-39-GB
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-03
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
2. Male subjects with the diagnosis of severe haemophilia A (FVIII less than or equal to 1%) from age 12 to 56 years having a weight of 10 to 120 kg
3. Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known or suspected hypersensitivity to trial product(s) or related products
2. Previous participation in this trial defined as withdrawal
3. Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
4. Any disease or condition which, according to the Investigator’s judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified