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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00922792
Other study ID # NN7128-3700
Secondary ID 2009-010080-16
Status Completed
Phase Phase 1
First received June 16, 2009
Last updated May 12, 2016
Start date June 2009
Est. completion date September 2009

Study information

Verified date May 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Haemophilia A or B

- Bodyweight max 100 kg

- Body Mass Index (BMI) max 30 kg/m2

- Adequate venous access

Exclusion Criteria:

- Known or suspected allergy to trial product(s) or related products (including NovoSeven®)

- The receipt of any investigational product within 30 days prior to enrolment in this trial

- Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial

- The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product

- Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration

- Known pseudo tumours

- Congenital or acquired coagulation disorders other than haemophilia A or B

- Any major and/or orthopaedic surgery within one month prior to trial start

- Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)

- Clinical signs of renal dysfunction

- Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug

- Use of non-prescribed opiate substances

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
activated recombinant human factor VII, long acting
Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration
activated recombinant human factor VII, long acting
Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of adverse events after 1 and 2 weeks after dosing Yes
Primary Frequency of serious adverse events after 1, 2 and 6-10 weeks after dosing Yes
Primary Frequency of MESIs (Medical Event of Special Interest) after 1, 2 and 6-10 weeks after dosing Yes
Primary Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa after 2 and 6-10 weeks after dosing Yes
Secondary Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½ from time of dosing up to 72 hours after the last dose No
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