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Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A

NCT01619046 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2014-07-03

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (\> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor VIII).

Conditions

Interventions

BIOLOGICAL

GreenGene™ F and an approved recombinant Factor VIII product

one 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate \< 10 mL/min

BIOLOGICAL

GreenGene™ F

intra-venous infusion, 30 ± 5 IU/kg infusions 3 times per week with dose escalation to 45 ± 5 IU/kg if appropriate, for 50 exposure days

BIOLOGICAL

GreenGene™ F

intra-venous infusion, On-demand safety and efficacy substudy: minor bleed = 10-20 IU/kg moderate bleed = 15-30 IU/kg major bleed = 30-50 IU/kg

BIOLOGICAL

GreenGene™ F

intra venous infusion, Surgical substudy: Minor surgery including tooth extraction = Post in fusion FVIII level of 60-100% of normal. A single bolus infusion (30-50 IU/kg) beginning within one hour of the operation. Optional additional dosing every 12 to 24 hours as needed to control bleeding. Major surgery = Pre- and post infusion FVIII level 80-120% of normal. Preoperative bolus infusion: 40-60 IU/kg. Verified 100% activity prior to surgery. Maintenance bolus infusion (40-60 IU/kg) repeat infusions every 8 to 24 hours, depending on the desired level.

Sponsors & Collaborators

  • Atlantic Research Group

    collaborator OTHER

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Paul LeoFrancis Giangrande, MD · Oxford Haemophilic Centre and Thrombosis Unit, Churchill Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • United States
  • Canada
  • New Zealand
  • Poland
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01619046 on ClinicalTrials.gov