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

NCT01288391 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2016-05-13

No results posted yet for this 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.

Conditions

  • Congenital Bleeding Disorder
  • Haemophilia A
  • Haemophilia B

Interventions

DRUG

NNC 0128-0000-2011

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

DRUG

NNC 0128-0000-2011

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

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Germany
  • Japan
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01288391 on ClinicalTrials.gov