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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023921-39-GB

Enrollment

Registered

2011-02-03

Start date

2011-04-27

Completion date

Unknown

Last updated

2012-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Haemophilia A MedDRA version: 12.1 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII)

Interventions

Product Name: N8 Product Code: NNC 0155-0000-0004 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: N8 CAS Number: 1192451-26-5 Current Sponsor code: NNC 0155-000

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the pharmacokinetics (PK) of two different lots of N8 after a single intravenous (i.v.) administration of 50 IU/kg b.w. in patients with haemophilia A.;Secondary Objective: To evaluate the safety of N8 after i.v. administration in patients with haemophilia A.;Primary end point(s): • Incremental recovery (IR30min)(defined as the peak level recorded 30 min after infusion and reported as [IU/mL]/[IU/kg]) • Terminal half-life (t½) • Clearance (CL) • Area under the Curve (AUC)	—

Measure

Time frame

Main Objective: To evaluate the pharmacokinetics (PK) of two different lots of N8 after a single intravenous (i.v.) administration of 50 IU/kg b.w. in patients with haemophilia A.;Secondary Objective: To evaluate the safety of N8 after i.v. administration in patients with haemophilia A.;Primary end point(s): • Incremental recovery (IR30min)(defined as the peak level recorded 30 min after infusion and reported as [IU/mL]/[IU/kg]) • Terminal half-life (t½) • Clearance (CL) • Area under the Curve (AUC)

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026