Clinical trial NCT01205724: Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A
Official title: A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.


Eligibility criteria: Inclusion Criteria:

* Haemophilia A
* Body Mass Index (BMI) below 35 kg/m2
* History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)

Exclusion Criteria:

* Any history of FVIII inhibitors
* Surgery planned to occur during the trial
* Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
* Congenital or acquired coagulation disorders other than haemophilia A

Primary outcomes:
measure: Frequency of adverse events (AEs) reported after administration of trial product
timeFrame: up to four weeks after trial product administration
Secondary outcomes:
measure: Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample)
timeFrame: from 0 to 168 hours after trial product administration
measure: Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments
timeFrame: up to four weeks after trial product administration
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Lexington
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Frankfurt/M.
country: Germany
facility: Novo Nordisk Investigational Site
city: Giessen
country: Germany
facility: Novo Nordisk Investigational Site
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Vicenza
country: Italy
facility: Novo Nordisk Investigational Site
city: Kashihara-shi, Nara
country: Japan
facility: Novo Nordisk Investigational Site
city: Nagoya-shi, Aichi
country: Japan
facility: Novo Nordisk Investigational Site
city: Shinjuku-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Zürich
country: Switzerland
facility: Novo Nordisk Investigational Site
city: Bornova-IZMIR
country: Turkey
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013 Apr;11(4):670-8. doi: 10.1111/jth.12161.