Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

NCT00922792 | Completed Phase 1

• 2 other identifiers: NN7128-37002009-010080-16
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Bleeding Disorder; Haemophilia A; Haemophilia B

Outcome Measures

Primary Outcomes (4)

• Frequency of adverse events

  after 1 and 2 weeks after dosing

• Frequency of serious adverse events

  after 1, 2 and 6-10 weeks after dosing

• Frequency of MESIs (Medical Event of Special Interest)

  after 1, 2 and 6-10 weeks after dosing

• Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa

  after 2 and 6-10 weeks after dosing

Secondary Outcomes (1)

• 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

Study Arms (2)

A

EXPERIMENTAL

Drug: activated recombinant human factor VII, long acting

B

EXPERIMENTAL

Drug: activated recombinant human factor VII, long acting

Interventions

activated recombinant human factor VII, long acting DRUG

Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Haemophilia A or B
• Bodyweight max 100 kg
• Body Mass Index (BMI) max 30 kg/m2
• Adequate venous access

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Madrid, 28046, Spain

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: June 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

ES (1)