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

NCT01568580 | Completed Phase 3

• 1 other identifier: GC8AIII
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hemophilia A

Keywords

Hemophilia A; Factor VIII; Recombinant

Outcome Measures

Primary Outcomes (2)

• Physician's assessment of hemostatic effect for on-demand treatment

  Category: Exellent, Good, Moderate, None

  12 months

• Hemostatic effect for major bleeding

  Category: Exellent, Good, Moderate, None

  up to 1 year

Secondary Outcomes (6)

• consumption amount of test drug

  up to 12 month or 100 exposure days

• Subject's self assessment of treatment

  12 months

• FVIII Recovery(%)

  every 3 months

• FVIII inhibitor incidence rate

  every 3 months

• The number of adverse events

  up to 1 year

Study Arms (1)

test drug

EXPERIMENTAL

GreenGene

Drug: GreenGene

Interventions

GreenGene DRUG

Dose : 10 \~ 50IU/kg Administration method : intravenous infusion or bolus

test drug

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Green Cross Corporation: lead

MeSH Terms

Conditions

Hemophilia A

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2012
• First Posted: April 2, 2012
• Study Start: December 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2006
• Last Updated: April 2, 2012

Record last verified: 2012-03