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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01288391
First received: February 1, 2011
Last updated: July 4, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Drug: NNC 0128-0000-2011
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Frequency of Adverse Events (AEs) [ Time Frame: from first trial product administration until 12 weeks after last trial product administration ] [ Designated as safety issue: No ]
  • Frequency of serious adverse events (SAEs) [ Time Frame: from first trial product administration until 12 weeks after last trial product administration ] [ Designated as safety issue: No ]
  • Frequency of MESIs (Medical Event of Special Interest) [ Time Frame: from first trial product administration until 12 weeks after last trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neutralising antibodies against FVIIa and/or N7-GP [ Time Frame: from first trial product administration until 12 weeks after last trial product administration ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 100 mcg/kg Drug: NNC 0128-0000-2011
Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
Experimental: 200 mcg/kg Drug: NNC 0128-0000-2011
Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288391

Locations
Germany
Berlin, Germany, 10249
Japan
Kitakyusyu,, Japan, 807-8555
Spain
Madrid, Spain, 28046
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Camilla Stenmo Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01288391     History of Changes
Other Study ID Numbers: NN7128-3840, 2010-021127-28, U1111-1118-6995, JapicCTI-111455
Study First Received: February 1, 2011
Last Updated: July 4, 2012
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines and Health Care Products

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014