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CompletedNCT01288391Updated May 13, 2016

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

A Phase 1 interventional study of NNC 0128-0000-2011 and NNC 0128-0000-2011 in Congenital Bleeding Disorder, Haemophilia A and Haemophilia B, sponsored by Novo Nordisk A/S. Completed at 3 sites in 3 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-13.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B
03

In context

Hemostatic Disorders

503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.

This study's enrollment of 15 is below the median of 51 across 253 interventional studies indexed under Hemostatic Disorders.

Browse Hemostatic Disorders studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    100 mcg/kg

    Drug: NNC 0128-0000-2011

  • Experimental
    200 mcg/kg

    Drug: NNC 0128-0000-2011

Interventions

  • DrugNNC 0128-0000-2011

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

  • DrugNNC 0128-0000-2011

    Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)

06

What researchers measure

Primary outcomes

  1. Frequency of Adverse Events (AEs)

    Time frame: from first trial product administration until 12 weeks after last trial product administration

  2. Frequency of serious adverse events (SAEs)

    Time frame: from first trial product administration until 12 weeks after last trial product administration

  3. Frequency of MESIs (Medical Event of Special Interest)

    Time frame: from first trial product administration until 12 weeks after last trial product administration

Secondary outcomes

  1. Neutralising antibodies against FVIIa and/or N7-GP

    Time frame: from first trial product administration until 12 weeks after last trial product administration

07

Study locations

3 sites
  • Berlin, 10249, Germany
  • Kitakyusyu,, 807-8555, Japan
  • Madrid, 28046, Spain
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01288391
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Feb 2, 2011
Start date
Jan 2011
Primary completion
Jul 2011
Completion
Jul 2011
Last update
May 13, 2016

Study contacts

Global Clinical Registry (GCR, 1452)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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