Hemophilia APhase 3NCT02027779
Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
A Phase 3 study testing GreenGene™ F in people with Hemophilia A, run by Green Cross Corporation at 2 sites in United States.
Trial summary
This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- GreenGene™ F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Feb 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects must have participated in the "GreenGene™ F_P3", (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F
- Have ≥50 previous exposure days to GreenGene™ F, as documented in the subject's medical records.
- Negative assays for FVIII inhibitor at inclusion (<0.6BU Nijmegen assay), i.e. at the end of study "GreenGene™ F_P3" for patients entering into this extension study immediately after finishing the previous phase III study.
- Normal liver and kidney function
- Platelet count ≥ 100,000㎕
- Normal prothrombin time or International Normalized Ratio (INR) < 1.5
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- Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen
- Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each inhibitor assay
- Absolute CD4 lymphocyte cell count ≥ 200㎕
- Signed the written informed consent form or informed consent was obtained from the subject's legal guardian
- Females must not be lactating or pregnant at screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG). A test was obtained more than 72 hours before the first dose of study drug
- All females will be considered to be of childbearing potential unless they are appropriate age group and without other known or suspected cause) or have been sterilized surgically (i.e. bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing)
- Willing and able to comply with all aspects of the protocol
Who cannot join
- Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay.
- Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices
- Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
- Hemoglobin < 10 g/dL
- Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin > 2x the ULN)
- Liver disease (alanine aminotransferase [ALT], aspartate aminotransferase [AST] > 3x the ULN)
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- History of diabetes or other metabolic disease
- History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrates
- History of pretreatment prior to the administration of FVIII products (e.g., antihistamines)
- Regular use of antifibrinolytics or medications affecting platelet function
- Hypersensitivity to hamster- or mouse derived proteins
- Blood transfusions within 30 days of enrollment into the study
- Current participation in another investigational drug or device study, or participated in a clinical study involving an investigational drug or device within 30 days of enrollment into the study
- Unable or unwilling to cooperate with study procedures
- Females who are pregnant (positive β-hCG test) or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Bryce Warren, 501-364-4003, WarrenBryceA@uams.edu
Kimo Stine, M.D.
- Recruiting
Long Island Jewish Medical Center - Hemophilia Treatment Center
New Hyde Park, New York, 11040
Patricia Murray, 718-470-7380, Pmurray1@nshs.edu
Lisa Patriarca, 718 470 7380, lpatriar@nshs.edu
About this study
Official title: An Open Label Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).
- Conditions
- Hemophilia A
- Being tested
- GreenGene™ F
- Keywords
- GreenGene™ F, Previously Treated Patients
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GreenGene™ FBiological
Also called GreenGeneF, GreenGene F
Prophylaxis safety and efficacy substudy:
intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days
GreenGene™ FBiological
Also called GreenGeneF, GreenGene F
On-demand safety and efficacy substudy:
minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis safety and efficacy substudy | Experimental | Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding during prophylaxis over ≥ 50 additional exposure days. Receives: Biological: GreenGene™ F |
| On-demand safety and efficacy substudy | Experimental | Hemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding in a minimum of 10 on demand treated subjects during additional 50 exposure days. Receives: Biological: GreenGene™ F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with development of inhibitors
Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months.
Measured: every 3 months, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027779
- Sponsor's protocol ID
- GreenGene™ F_E_P3
- Status last verified
- Jan 2014
- First submitted
- 2 Jan 2014
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A
- ClinicalTrials.gov ID
- NCT02027779
- Acronym / sponsor ID
- GreenGene™ F_E_P3
- Conditions
- Hemophilia A
- Keywords
- GreenGene™ F, Previously Treated Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 6 Jan 2014 (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.
This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis safety and efficacy substudy | Experimental | Biological: GreenGene™ FHemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding during prophylaxis over ≥ 50 additional exposure days. |
| On-demand safety and efficacy substudy | Experimental | Biological: GreenGene™ FHemostatic efficacy of GreenGene™ F will be assessed by its effectiveness in controlling spontaneous or traumatic bleeding episodes and by the rate of breakthrough bleeding in a minimum of 10 on demand treated subjects during additional 50 exposure days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must have participated in the "GreenGene™ F_P3", (with Eudra CT number 2012-001445-40) or a pediatric study with GreenGene™ F
- Have ≥50 previous exposure days to GreenGene™ F, as documented in the subject's medical records.
- Negative assays for FVIII inhibitor at inclusion (<0.6BU Nijmegen assay), i.e. at the end of study "GreenGene™ F_P3" for patients entering into this extension study immediately after finishing the previous phase III study.
- Normal liver and kidney function
- Platelet count ≥ 100,000㎕
Key exclusion criteria (15 listed)
- Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay.
- Laboratory or clinical evidence of portal vein hypertension including, but not limited to, an INR > 1.4, the presence of splenomegaly and/or spider angiomata of physical examination and/or a history of esophageal hemorrhage or documented esophageal varices
- Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
- Hemoglobin < 10 g/dL
- Severe renal dysfunction (creatinine > 2x upper limit of normal [ULN], total bilirubin > 2x the ULN)
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 |
|---|---|---|
| GreenGene™ FAlso: GreenGeneF, GreenGene FProphylaxis safety and efficacy substudy: intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days | Biological | Prophylaxis safety and efficacy substudy |
| GreenGene™ FAlso: GreenGeneF, GreenGene FOn-demand safety and efficacy substudy: minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg | Biological | On-demand safety and efficacy substudy |
Primary outcome
Number of subjects with development of inhibitors
Time frame: every 3 months, up to 18 months
Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GreenGene™ F in people with Hemophilia A, run by Green Cross Corporation at 2 sites in United States.
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 13 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Hee Lee, M.D. (+82 31 260 9729, chleedr@greencross.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with development of inhibitors (time frame: every 3 months, up to 18 months). 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 6 Jan 2014.