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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Congenital Bleeding Disorder Haemophilia A Haemophilia B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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100 mcg/kg

Group Type EXPERIMENTAL

NNC 0128-0000-2011

Intervention Type DRUG

Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

200 mcg/kg

Group Type EXPERIMENTAL

NNC 0128-0000-2011

Intervention Type DRUG

Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

Interventions

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NNC 0128-0000-2011

Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

Intervention Type DRUG

NNC 0128-0000-2011

Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No