Hemophilia APhase 3NCT01568580
Efficacy and Safety of Recombinant Factor VIII (GreenGene) in Patients With Hemophilia A
A Phase 3 study testing GreenGene in people with Hemophilia A, run by Green Cross Corporation.
Trial summary
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemophilia A
- What is being tested?
- GreenGene
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Sep 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
About this study
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
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).
- Conditions
- Hemophilia A
- Being tested
- GreenGene
- Keywords
- Hemophilia A, Factor VIII, Recombinant
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GreenGeneDrug
Dose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus
| Study group | Role | What they receive |
|---|---|---|
| test drug | Experimental | GreenGene Receives: Drug: GreenGene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician's assessment of hemostatic effect for on-demand treatment
Category: Exellent, Good, Moderate, None
Measured: 12 months
Hemostatic effect for major bleeding
Category: Exellent, Good, Moderate, None
Measured: up to 1 year
Secondary outcomes (6)
consumption amount of test drug
Measured: up to 12 month or 100 exposure days
Subject's self assessment of treatment
Category: Exellent, Good, Moderate, None
Measured: 12 months
FVIII Recovery(%)
Measured: every 3 months
FVIII inhibitor incidence rate
Measured: every 3 months
The number of adverse events
Measured: up to 1 year
Surgery study: prohylactic effects
Category: Exellent, Good, Moderate, None
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startDec 2004
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568580
- Sponsor's protocol ID
- GC8AIII
- Status last verified
- Mar 2012
- First submitted
- 22 Mar 2012
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01568580
- Acronym / sponsor ID
- GC8AIII
- Conditions
- Hemophilia A
- Keywords
- Hemophilia A, Factor VIII, Recombinant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the evaluation of efficacy and safety of GreenGene (Recombinant Factor VIII).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| test drug | Experimental | Drug: GreenGeneGreenGene |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GreenGeneDose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus | Drug | test drug |
Primary outcome
Physician's assessment of hemostatic effect for on-demand treatment
Time frame: 12 months
Category: Exellent, Good, Moderate, None
Hemostatic effect for major bleeding
Time frame: up to 1 year
Category: Exellent, Good, Moderate, None
6 secondary outcomes
consumption amount of test drug
Time frame: up to 12 month or 100 exposure days
Subject's self assessment of treatment
Time frame: 12 months
FVIII Recovery(%)
Time frame: every 3 months
FVIII inhibitor incidence rate
Time frame: every 3 months
The number of adverse events
Time frame: up to 1 year
Surgery study: prohylactic effects
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GreenGene in people with Hemophilia A, run by Green Cross Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physician's assessment of hemostatic effect for on-demand treatment (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.