Efficacy and Safety of Recombinant Factor VIII (GreenGene... | NCT01568580

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

NCT01568580

Sponsor

Green Cross Corporation

Status

Completed

Last Update Posted

Apr 2, 2012Estimated

Enrollment

71Actual

Phase

Phase 3

Conditions

Hemophilia A

Interventions

GreenGene

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Mar 22, 2012

First Submission Date that Met QC Criteria

Mar 29, 2012

First Posted Date

Apr 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2012

Last Update Posted Date

Apr 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Label	Type	Description	Intervention Names
test drug	Experimental	GreenGene	Drug: GreenGene

Name	Type	Description	Arm Group Labels	Other Names
GreenGene	Drug	Dose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus	test drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
consumption amount of test drug		up to 12 month or 100 exposure days
Subject's self assessment of treatment	Category: Exellent, Good, Moderate, None	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases