NCT01288391

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

February 1, 2011

Last Update Submit

May 12, 2016

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia B

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Neutralising antibodies against FVIIa and/or N7-GP

    from first trial product administration until 12 weeks after last trial product administration

Study Arms (2)

100 mcg/kg

EXPERIMENTAL
Drug: NNC 0128-0000-2011

200 mcg/kg

EXPERIMENTAL
Drug: NNC 0128-0000-2011

Interventions

NNC 0128-0000-2011DRUG

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

100 mcg/kg

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Berlin, 10249, Germany

Location

Unknown Facility

Kitakyushu, 807-8555, Japan

Location

Unknown Facility

Madrid, 28046, Spain

Location

Related Links

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 2, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

DE(1)JP(1)ES(1)