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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01568580

Enrollment

Registered

2012-04-02

Start date

2004-12-31

Completion date

2006-09-30

Last updated

2012-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Keywords

Hemophilia A, Factor VIII, Recombinant

Brief summary

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

Interventions

DRUGGreenGene

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Physician's assessment of hemostatic effect for on-demand treatment	12 months	Category: Exellent, Good, Moderate, None
Hemostatic effect for major bleeding	up to 1 year	Category: Exellent, Good, Moderate, None

Secondary

Measure	Time frame	Description
Subject's self assessment of treatment	12 months	Category: Exellent, Good, Moderate, None
FVIII Recovery(%)	every 3 months	—
Surgery study: prohylactic effects	up to 1 year	Category: Exellent, Good, Moderate, None
The number of adverse events	up to 1 year	—
FVIII inhibitor incidence rate	every 3 months	—
consumption amount of test drug	up to 12 month or 100 exposure days	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026