Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Haemophilia B

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: NNC 0128-0000-2011

Study type

Interventional

Funder types

Industry

Identifiers

NCT01288391

2010-021127-28 (EudraCT Number)

U1111-1118-6995 (Other Identifier)

JapicCTI-111455 (Registry Identifier)

NN7128-3840

Details and patient eligibility

About

This trial is conducted in Europe and Japan. The aim of this trial is to assess the safety and pharmacokinetics (the rate at which the body eliminates the trial drug) of single doses of NNC128-0000-2011, when administered i.v. (intravenously) to haemophilia patients.

Enrollment

15 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients diagnosed with haemophilia A or B (with or without inhibitors and irrespective of severity) based on medical records
Japan: A legally acceptable representative (LAR) is required for patients between 18 and 19 years
Body weight less than or equal to 100.0 kg
Body Mass Index (BMI) less than or equal to 30.0 kg/m^2

Exclusion criteria

Known or suspected allergy to trial product(s) or related products (including rFVIIa)
Previous participation in this trial defined as administration of trial product
The receipt of any investigational product within 30 days prior to trial start (screening)
Congenital or acquired coagulation disorders other than haemophilia A or B
Receipt of Immune Tolerance Induction (ITI) within the last 30 days prior to screening
Any surgery within 30 days prior to screening
Planned surgery within the trial period
Platelet count below 50,000 platelets/mcL (based on medical records within the last 1 month or laboratory results at screening)
Prothrombin time (PT) above 4 times Upper limit of normal (ULN) or International normalised ratio (INR) greater than 1.7
Hepatic dysfunction or severe hepatic disease as evaluated by the investigator (trial physician)
Renal dysfunction (dialysis) and/or creatinine levels more than or equal to 20% above upper normal limit (according to medical records or laboratory results at screening)
Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
Any disease, condition, or medication which, according to the investigator's (trial physician) judgement, could imply a potential hazard to the patient or interfere with the trial participation or trial outcome
Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate understanding and cooperation