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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
• Interventions: Drug: NNC 0128-0000-2011

• Registration Number: NCT01288391
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
200 mcg/kg	NNC 0128-0000-2011	-
100 mcg/kg	NNC 0128-0000-2011	-

Primary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs)	from first trial product administration until 12 weeks after last trial product administration
Frequency of serious adverse events (SAEs)	from first trial product administration until 12 weeks after last trial product administration
Frequency of MESIs (Medical Event of Special Interest)	from first trial product administration until 12 weeks after last trial product administration

Secondary Outcome Measures

Name	Time	Method
Neutralising antibodies against FVIIa and/or N7-GP	from first trial product administration until 12 weeks after last trial product administration