Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A
NCT ID: NCT01619046
Last Updated: 2014-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
124 participants
INTERVENTIONAL
2013-03-31
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PK substudy
A cohort of 13-18 subjects will be included in the pharmacokinetic (PK) evaluation of GreenGene™ F and an approved recombinant Factor VIII product (Refacto AF); a minimum of 13 of these subjects will be re-evaluated at study end (50 exposure day).
GreenGene™ F and an approved recombinant Factor VIII product
one 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate \< 10 mL/min
Prophylaxis safety and efficacy substudy
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 exposure days.
GreenGene™ F
intra-venous infusion, 30 ± 5 IU/kg infusions 3 times per week with dose escalation to 45 ± 5 IU/kg if appropriate, for 50 exposure days
On-demand safety and efficacy substudy
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 50 exposure days.
GreenGene™ F
intra-venous infusion,
On-demand safety and efficacy substudy:
minor bleed = 10-20 IU/kg moderate bleed = 15-30 IU/kg major bleed = 30-50 IU/kg
Surgical substudy
Peri-operative hemostatic control of GreenGene™ F in surgery or invasive procedures will be assessed in at least 10 surgeries, some of them major, in at least five subjects
GreenGene™ F
intra venous infusion,
Surgical substudy:
Minor surgery including tooth extraction = Post in fusion FVIII level of 60-100% of normal. A single bolus infusion (30-50 IU/kg) beginning within one hour of the operation. Optional additional dosing every 12 to 24 hours as needed to control bleeding.
Major surgery = Pre- and post infusion FVIII level 80-120% of normal. Preoperative bolus infusion: 40-60 IU/kg. Verified 100% activity prior to surgery. Maintenance bolus infusion (40-60 IU/kg) repeat infusions every 8 to 24 hours, depending on the desired level.
Interventions
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GreenGene™ F and an approved recombinant Factor VIII product
one 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate \< 10 mL/min
GreenGene™ F
intra-venous infusion, 30 ± 5 IU/kg infusions 3 times per week with dose escalation to 45 ± 5 IU/kg if appropriate, for 50 exposure days
GreenGene™ F
intra-venous infusion,
On-demand safety and efficacy substudy:
minor bleed = 10-20 IU/kg moderate bleed = 15-30 IU/kg major bleed = 30-50 IU/kg
GreenGene™ F
intra venous infusion,
Surgical substudy:
Minor surgery including tooth extraction = Post in fusion FVIII level of 60-100% of normal. A single bolus infusion (30-50 IU/kg) beginning within one hour of the operation. Optional additional dosing every 12 to 24 hours as needed to control bleeding.
Major surgery = Pre- and post infusion FVIII level 80-120% of normal. Preoperative bolus infusion: 40-60 IU/kg. Verified 100% activity prior to surgery. Maintenance bolus infusion (40-60 IU/kg) repeat infusions every 8 to 24 hours, depending on the desired level.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body weight ≥ 35 kg
3. Diagnosed with severe hemophilia A. All subjects must have severe hemophilia A with baseline FVIII \<1% activity; \<0.01 IU/mL
4. Have ≥ 150 previous exposure days to FVIII concentrates, as documented in the subject's medical records
5. Subjects included in the on-demand treatment cohort must have a verifiable record of at least three bleeding episodes per month on average in the last 6 months prior to enrollment
6. Negative assays for FVIII inhibitor at inclusion (\<0.6BU Nijmegen assay)
7. Negative assays for FVIII inhibitor in subject files (\<0.6BU Nijmegen assay) No history of positive inhibitor is allowed
8. Normal liver and kidney function.
9. Platelet count ≥ 100,000 μL
10. Normal prothrombin time or International Normalized Ratio (INR) \< 1.5
11. Subjects receiving therapy for human immunodeficiency virus (HIV) or hepatitis must be on a stable treatment regimen
12. Subjects must be able to withhold FVIII infusions for approximately 72 h prior to each FVIII activity and inhibitor assay (96 h if participating in the PK sub study)
13. Absolute CD4 lymphocyte cell count ≥ 200 μL
14. Signed the written informed consent form or informed consent was obtained from the subject's legal guardian
15. Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin \[ß hCG\] test with a minimum sensitivity of 25 IU/L or equivalent units of ß hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug
16. All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the 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)
17. Willing and able to comply with all aspects of the protocol
Exclusion Criteria
2. History of FVIII inhibitor of ≥ 0.6 BU as measured using the Nijmegen modification of the Bethesda assay
3. History of FVIII inhibitor ≥ 1.0 BU if the subject has been tested routinely using the original Bethesda assay, or history of periods with low recovery and no response to Factor VIII treatment
4. Demonstrated an inability to respond to conventional doses of FVIII therapy
5. History of incremental recovery of Factor VIII \<1.35% per IU/kg infused
6. Hematological disorders or blood coagulation diseases (e.g., idiopathic thrombocytopenic purpura, von Willebrand disease, etc.) other than hemophilia A
7. 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 on physical examination and/or a history of esophageal hemorrhage or documented esophageal varices
8. Uncontrolled hypertension (diastolic blood pressure \>100 mm Hg)
9. Hemoglobin \< 10 g.dL
10. HIV disease symptoms regardless of presence of HIV antibodies
11. Routine administration (or planned routine administration during the course of the study), of immunosuppressive or immunomodulating drugs other than antiretroviral therapy (e.g., steroids, beta-interferon)
12. Severe renal dysfunction (creatinine \> 2x upper limit of normal \[ULN\], total bilirubin \> 2x the ULN)
13. Liver disease (alanine aminotransferase \[ALT\], aspartate aminotransferase \[ AST\] \> 3x the ULN)
14. History of diabetes or other metabolic disease
15. History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrate
16. History of pretreatment prior to the administration of FVIII products (e.g., of antihistamines)
17. Regular use of antifibrinolytics or medications affecting platelet function
18. Hypersensitivity to hamster-or mouse derived proteins
19. Blood transfusions within 30 days of enrollment into the study
20. 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
21. Unable or unwilling to cooperate with study procedures
12 Years
ALL
No
Sponsors
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Atlantic Research Group
OTHER
Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Paul LeoFrancis Giangrande, MD
Role: PRINCIPAL_INVESTIGATOR
Oxford Haemophilic Centre and Thrombosis Unit, Churchill Hospital
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Los Angeles Orthopaedic Hospital - Hemophilia Treatment Center
Los Angeles, California, United States
Harbor - UCLA Pediatrics
Torrance, California, United States
University of Miami - Comprehensive Hemophilia Center
Miami, Florida, United States
St. Luke's Boise Medical Center
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Michigan State University Center for Bleeding Disorders & Clotting Disorders
East Lansing, Michigan, United States
Children's Mercy Hospital - Kansas City Regional Hemophilia Center
Kansas City, Missouri, United States
Long Island Jewish Medical Center - Hemophilia Treatment Center
New Hyde Park, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Alberta
Edmonton, Alberta, Canada
McMaster Children's Hospital
Hamilton, Ontario, Canada
Research Associates, Ltd.
Christchurch, New Zealand, New Zealand
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
wojewodzki szpital Specjalistyczny, klinika hematologii uniwersytetu medycznego w łodzi
Łodzi, , Poland
Barnaul Altai State Scientfic Center
Barnaul, , Russia
Kirov Research Institute of Hematology and Blood Transfusion
Kirov, , Russia
Ismailov City Children's Clinical Hospital of Board of Health of Moscow City
Moscow, , Russia
State Budget Educational Institution of Higher professional Education "Samara State Medical University" of the Ministry of Health and Social Process of the Russian Federation
Samara, , Russia
Ufa Republican Clinical Hospital
Ufa, , Russia
Dnepropetrovsk City Clinical Hospital
Dnipro, , Ukraine
Institute of Urgent and Reconstructive surgery named after V.K. Gusak of National Academy of Medical Sciences of Ukraine
Donetsk, , Ukraine
Kharkov Regional Clinical Oncology Center
Kharkiv, , Ukraine
Kyiv City Clinical Hospital No 91
Kyiv, , Ukraine
Institute of Blood Pathology and Transfusion Medicine of National Academy of Medical Sciences of Ukraine Department of Surgery and Clinical Transfusiology
Lviv, , Ukraine
Zaporizhzhya Region Clinical Child Hospital
Zaporzhye, , Ukraine
Royal Cornwall Hospital, Department of Haematology
Truro, Cornwall, United Kingdom
Hull Haemophillia Centre, Hull Royal Infirmary
Humberside, Hull, United Kingdom
Central Manchester University Hospitals
Manchester, Lancashire, United Kingdom
St. Thomas' Hospital
City of Westminster, London, United Kingdom
North Hampshire Haemophilia Centre
Basingstoke, North Hampshire, United Kingdom
University of Liverpool
Liverpool, , United Kingdom
Royal Free Hospital, Haemophilia Centre & Thrombosis Unit
London, , United Kingdom
Churchill Hospital, Oxford
Oxford, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GreenGeneF_P3
Identifier Type: -
Identifier Source: org_study_id
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