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Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01568580
First received: March 22, 2012
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).


Condition Intervention Phase
Hemophilia A
 Drug: GreenGene
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Non-comparative, Multicenter, Phase III for Evaluation of Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Previously Treated Patients With Hemophilia A

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Green Cross Corporation:

Primary Outcome Measures:
  • Physician's assessment of hemostatic effect for on-demand treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Category: Exellent, Good, Moderate, None

  • Hemostatic effect for major bleeding [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Category: Exellent, Good, Moderate, None


Secondary Outcome Measures:
  • consumption amount of test drug [ Time Frame: up to 12 month or 100 exposure days ] [ Designated as safety issue: No ]
  • Subject's self assessment of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Category: Exellent, Good, Moderate, None

  • FVIII Recovery(%) [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
  • FVIII inhibitor incidence rate [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]
  • The number of adverse events [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
  • Surgery study: prohylactic effects [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
    Category: Exellent, Good, Moderate, None


Enrollment: 71
Study Start Date: December 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: test drug
GreenGene
 Drug: GreenGene
Dose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemophilia A patients at least 12 years of age
  • At least 150 treatment exposure-days to previous FVIII products
  • FVIII≤2% at screening or diagnosis (FVIII≤1% for PK study)
  • CD4 Lympocyte cell count>400/㎕
  • Patients willing to cooperate for the study
  • Patient's or legal guardian's consent to participate in the study

Exclusion Criteria:

  • FVIII inhibitor(neutralizing antibody to FVIII)≥0.6 Bethesda Units
  • Coagulation disorders other than hemophilia A (e.g. Idiopathic Thrombocytopenic Purpura, von Willebrand Disease)
  • Platelet count≤100,000㎣
  • Subjects with clinical evidence of symptomatic HIV disease regardless of HIV-seroposive/seronegative
  • Subjects with rFVIII antibody, mouse IgG antibody, or CHO antibody
  • Creatinine levels more than 2 times of reference rage, GOT and GPT levels more than 3 times of reference range, diabetes mellitus or other metabolic disorder
  • Subjects with diastolic blood pressure≥100mmHg not controlled with antihypertensive medications
  • Anemia(hemoglobin<12g/dL)
  • Subjects with severe or life-threatening bleeding just before entry into the trial
  • Subjects with a history of treatment failure due to formation of inhibitor to FVIII
  • Subjects with a history of severe hypersensitive reactions to FVIII concentrate
  • Subjects requiring pre-medication for FVIII infusion(e.g. antihistamines, etc)
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT01568580     History of Changes
Other Study ID Numbers: GC8AIII
Study First Received: March 22, 2012
Last Updated: March 29, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Green Cross Corporation:
Hemophilia A
Factor VIII
Recombinant

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
 Genetic Diseases, Inborn
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013