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

Congenital Bleeding Disorder Clinical Trial

Official title:

An Open Non-randomised Dose Escalation Trial Investigating the Safety and Pharmacokinetics of Single Intravenous Administrations of NNC128-0000-2011 in Patients With Haemophilia A or B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288391
• Other study ID #: NN7128-3840
• Secondary ID: 2010-021127-28U1
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2011
• Last updated: May 12, 2016
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: May 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labour and Welfare (MHLW)Germany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of Medicines and Health Care Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• NNC 0128-0000-2011
Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
• NNC 0128-0000-2011
Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Japan,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of Adverse Events (AEs)		from first trial product administration until 12 weeks after last trial product administration	No
Primary	Frequency of serious adverse events (SAEs)		from first trial product administration until 12 weeks after last trial product administration	No
Primary	Frequency of MESIs (Medical Event of Special Interest)		from first trial product administration until 12 weeks after last trial product administration	No
Secondary	Neutralising antibodies against FVIIa and/or N7-GP		from first trial product administration until 12 weeks after last trial product administration	No

External Links

•   Clinical Trials at Novo Nordisk