Suspended

Determination of Safety, Efficacy and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 Years of Age or Older Diagnosed With Severe Hemophilia A

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What is being tested

GreenGene™ F and an approved recombinant Factor VIII product

+ GreenGene™ F

Biological
Who is being recruted

Blood Coagulation Disorders+6

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 12 Years
+38 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorGreen Cross Corporation
Study ContactKevin Wait
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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).

Official TitleDetermination of Safety, Efficacy and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 Years of Age or Older Diagnosed With Severe Hemophilia A
NCT01619046
Principal SponsorGreen Cross Corporation
Study ContactKevin Wait
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

124 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemophilia AHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCoagulation Protein DisordersBlood Coagulation Disorders, InheritedGenetic Diseases, Inborn

Criteria

17 inclusion criteria required to participate
Male or female subjects age ≥ 12 years at the time of informed consent
Body weight ≥ 35 kg
Diagnosed with severe hemophilia A. All subjects must have severe hemophilia A with baseline FVIII <1% activity; <0.01 IU/mL
Have ≥ 150 previous exposure days to FVIII concentrates, as documented in the subject's medical records
Show More Criteria
21 exclusion criteria prevent from participating
Blood transfusions within 30 days of enrollment into the study
Hypersensitivity to hamster-or mouse derived proteins
Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay in either central or local laboratory
History of FVIII inhibitor of ≥ 0.6 BU as measured using the Nijmegen modification of the Bethesda assay
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
A cohort of 13-18 subjects will be included in the pharmacokinetic (PK) evaluation of GreenGene™ F and an approved recombinant Factor VIII product (Refacto AF); a minimum of 13 of these subjects will be re-evaluated at study end (50 exposure day).

Group II

Experimental
Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding during prophylaxis over ≥ 50 exposure days.

Group III

Experimental
Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding in a minimum of 10 on demand treated subjects during 50 exposure days.

Group IV

Experimental
Peri-operative hemostatic control of GreenGene™ F in surgery or invasive procedures will be assessed in at least 10 surgeries, some of them major, in at least five subjects

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 34 locations

Recruiting

Arkansas Children's Hospital

Little Rock, United StatesOpen Arkansas Children's Hospital in Google Maps
Recruiting

Los Angeles Orthopaedic Hospital - Hemophilia Treatment Center

Los Angeles, United States
Recruiting

Harbor - UCLA Pediatrics

Torrance, United States
Recruiting

University of Miami - Comprehensive Hemophilia Center

Miami, United States
Suspended34 Study Centers