Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Green Cross Corporation
Sponsor:
Collaborator:
Atlantic Research Group
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT02027779
First received: January 2, 2014
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).


Condition Intervention Phase
Hemophilia A
Biological: GreenGene™ F
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A

Resource links provided by NLM:


Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Number of subjects with development of inhibitors [ Time Frame: every 3 months, up to 18 months ] [ Designated as safety issue: Yes ]
    Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months.


Estimated Enrollment: 150
Study Start Date: January 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prophylaxis safety and efficacy substudy
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 additional exposure days.
Biological: GreenGene™ F

Prophylaxis safety and efficacy substudy:

intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days

Other Names:
  • GreenGeneF
  • GreenGene F
Experimental: On-demand safety and efficacy substudy
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 additional 50 exposure days.
Biological: GreenGene™ F

On-demand safety and efficacy substudy:

minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg

Other Names:
  • GreenGeneF
  • GreenGene F

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must have participated in the "GreenGene™ F_P3", (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F
  2. Have ≥50 previous exposure days to GreenGene™ F, as documented in the subject's medical records.
  3. Negative assays for FVIII inhibitor at inclusion (<0.6BU Nijmegen assay), i.e. at the end of study "GreenGene™ F_P3" for patients entering into this extension study immediately after finishing the previous phase III study.
  4. Normal liver and kidney function
  5. Platelet count ≥ 100,000㎕
  6. Normal prothrombin time or International Normalized Ratio (INR) < 1.5
  7. Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen
  8. Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each inhibitor assay
  9. Absolute CD4 lymphocyte cell count ≥ 200㎕
  10. Signed the written informed consent form or informed consent was obtained from the subject's legal guardian
  11. Females must not be lactating or pregnant at screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG). A test was obtained more than 72 hours before the first dose of study drug
  12. All females will be considered to be of childbearing potential unless they are appropriate age group and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing)
  13. Willing and able to comply with all aspects of the protocol

Exclusion Criteria:

  1. Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay.
  2. Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices
  3. Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
  4. Hemoglobin < 10 g/dL
  5. Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin > 2x the ULN)
  6. Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 3x the ULN)
  7. History of diabetes or other metabolic disease
  8. History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrates
  9. History of pretreatment prior to the administration of FVIII products (e.g., antihistamines)
  10. Regular use of antifibrinolytics or medications affecting platelet function
  11. Hypersensitivity to hamster- or mouse derived proteins
  12. Blood transfusions within 30 days of enrollment into the study
  13. Current participation in another investigational drug or device study, or participated in a clinical study involving an investigational drug or device within 30 days of enrollment into the study
  14. Unable or unwilling to cooperate with study procedures
  15. Females who are pregnant (positive β-hCG test) or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02027779

Contacts
Contact: Chang Hee Lee, M.D. +82 31 260 9729 chleedr@greencross.com
Contact: Kevin Wait +1 540 649 5490 kwait@atlanticresearchgroup.com

Locations
United States, Arkansas
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Bryce Warren    501-364-4003    WarrenBryceA@uams.edu   
Principal Investigator: Kimo Stine, M.D.         
United States, New York
Long Island Jewish Medical Center - Hemophilia Treatment Center Recruiting
New Hyde Park, New York, United States, 11040
Contact: Patricia Murray    718-470-7380    Pmurray1@nshs.edu   
Contact: Lisa Patriarca    718 470 7380    lpatriar@nshs.edu   
Principal Investigator: Richard Lipton, M.D.         
Sponsors and Collaborators
Green Cross Corporation
Atlantic Research Group
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT02027779     History of Changes
Other Study ID Numbers: GreenGene™ F_E_P3
Study First Received: January 2, 2014
Last Updated: January 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Green Cross Corporation:
GreenGene™ F, Previously Treated Patients

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on October 20, 2014