Back to resultsInvestigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
NNC 0128-0000-2011
NNC 0128-0000-2011
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
100 mcg/kg
200 mcg/kg
Arm Description
Outcomes
Primary Outcome Measures
Frequency of Adverse Events (AEs)
Frequency of serious adverse events (SAEs)
Frequency of MESIs (Medical Event of Special Interest)
Secondary Outcome Measures
Neutralising antibodies against FVIIa and/or N7-GP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01288391
Brief Title
Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
100 mcg/kg
Arm Type
Experimental
Arm Title
200 mcg/kg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC 0128-0000-2011
Intervention Description
Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
Intervention Type
Drug
Intervention Name(s)
NNC 0128-0000-2011
Intervention Description
Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
Primary Outcome Measure Information:
Title
Frequency of Adverse Events (AEs)
Time Frame
from first trial product administration until 12 weeks after last trial product administration
Title
Frequency of serious adverse events (SAEs)
Time Frame
from first trial product administration until 12 weeks after last trial product administration
Title
Frequency of MESIs (Medical Event of Special Interest)
Time Frame
from first trial product administration until 12 weeks after last trial product administration
Secondary Outcome Measure Information:
Title
Neutralising antibodies against FVIIa and/or N7-GP
Time Frame
from first trial product administration until 12 weeks after last trial product administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Berlin
ZIP/Postal Code
10249
Country
Germany
City
Kitakyusyu,
ZIP/Postal Code
807-8555
Country
Japan
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Investigating Safety and Pharmacokinetics of 2 Different Single Doses of NNC128-0000-2011 in Haemophilia A or B Patients
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