Hemophilia APhase 3NCT01619046
Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A
A Phase 3 study testing GreenGene™ F and an approved recombinant Factor VIII product and GreenGene™ F in people with Hemophilia A, run by Green Cross Corporation at 34 sites in 7 countries.
Trial summary
The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (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™ F and an approved recombinant Factor VIII product and GreenGene™ F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 34 sitesin 7 countries
- Study dates
- Mar 2013to Sep 2015
- 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
- Male or female subjects age ≥ 12 years at the time of informed consent
- Body weight ≥ 35 kg
- Diagnosed with severe hemophilia A. All subjects must have severe hemophilia A with baseline FVIII <1% activity; <0.01 IU/mL
- Have ≥ 150 previous exposure days to FVIII concentrates, as documented in the subject's medical records
- 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
- Negative assays for FVIII inhibitor at inclusion (<0.6BU Nijmegen assay)
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- Negative assays for FVIII inhibitor in subject files (<0.6BU Nijmegen assay) No history of positive inhibitor is allowed
- Normal liver and kidney function.
- Platelet count ≥ 100,000 μL
- Normal prothrombin time or International Normalized Ratio (INR) < 1.5
- 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 FVIII activity and inhibitor assay (96 h if participating in the PK sub study)
- Absolute CD4 lymphocyte cell count ≥ 200 μL
- 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 [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
- 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)
- 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 in either central or local laboratory
- History of FVIII inhibitor of ≥ 0.6 BU as measured using the Nijmegen modification of the Bethesda assay
- 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
- Demonstrated an inability to respond to conventional doses of FVIII therapy
- History of incremental recovery of Factor VIII <1.35% per IU/kg infused
- Hematological disorders or blood coagulation diseases (e.g., idiopathic thrombocytopenic purpura, von Willebrand disease, etc.) other than hemophilia A
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- 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
- Uncontrolled hypertension (diastolic blood pressure >100 mm Hg)
- Hemoglobin < 10 g.dL
- HIV disease symptoms regardless of presence of HIV antibodies
- 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)
- 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)
- History of diabetes or other metabolic disease
- History of hypersensitivity or serious adverse reaction to recombinant or plasma-derived FVIII concentrate
- History of pretreatment prior to the administration of FVIII products (e.g., of 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
Trial locations and contacts
34 sites in 7 countries.
34 sites in 7 countries
United States10 sites, 10 recruiting
- Recruiting
St. Luke's Boise Medical Center
Boise, Idaho, 83712
Tammie Eslinger, 208-381-2774, eslinget@slhs.org
Tim Honeycutt, 208-381-5357, honeycut@slhs.org
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Kristen Boyce, 312-942-0243, kristin_boyce@rush.edu
Rosie Howard, 312-942-7902, Rosie_Howard@rush.edu
- Recruiting
Michigan State University Center for Bleeding Disorders & Clotting Disorders
East Lansing, Michigan, 48823
Sue Adkins, 517-353-9385, sue.adkins@hc.msu.edu
Hillary Witkop, 517-353-9385, witkophi@msu.edu
- Recruiting
Children's Mercy Hospital - Kansas City Regional Hemophilia Center
Kansas City, Missouri, 64108
Sara Streeter, 816-234-3502, sstreeter@cmh.edu
Brian Wicklund, M.D.
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Bryce Warren, WarrenBryceA@uams.edu
Kimo Stine, MD
- Recruiting
Los Angeles Orthopaedic Hospital - Hemophilia Treatment Center
Los Angeles, California, 90007
Manny Mangilit, 213-742-1402, mannymangilit@gmail.com
Lucy Lacanilao, 213-742-1407, LLacanilao@mednet.ucla.edu
- Recruiting
University of Miami - Comprehensive Hemophilia Center
Miami, Florida, 33101
Clara Ibarra, 305-243-5343, cibarra@med.miami.edu
Cecilia Prado, 305-243-6925, cprado@med.miami.edu
- 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
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Kathy Beach, 503-494-7425, beachk@ohsu.edu
Alysia Cox, 503-494-5109, coxal@ohsu.edu
- Recruiting
Harbor - UCLA Pediatrics
Torrance, California, 90509
Amy Warder, 310-222-3621, awarder@labiomed.org
Helen Todoroki, 310-222-4156, htodoroki@labiomed.org
United Kingdom8 sites, 8 recruiting
- Recruiting
North Hampshire Haemophilia Centre
Basingstoke, North Hampshire, RG24 9NA
Yvonne Watson, 01256 314793, yvonne.watson@hhft.nhs.uk
Savita Rangarajan
- Recruiting
St. Thomas' Hospital
City of Westminster, London, SE1 7EH
Elsa Aradom, 020-7188-2781, elsa.aradom@gstt.nhs.uk
Sheela Medahunsi, 020-7188-2808, Sheela.Medahunsi@gstt.nhs.uk
- Recruiting
Hull Haemophillia Centre, Hull Royal Infirmary
Humberside, Hull, HU3 2JZ HU3 2JZ
Lisa Armitage, 01482 461254, lisa.armitage@hey.nhs.uk
David Allsup, M.D.
- Recruiting
University of Liverpool
Liverpool, L69 3GA
Clare Kay-Jones, +44(0)151 706 4329, clare.kay-jones@rlbuht.nhs.uk
Jayne Keaney, +44(0)151 706 4329, jayne.keaney@rlbuht.nhs.uk
- Recruiting
Royal Free Hospital, Haemophilia Centre & Thrombosis Unit
London, NW3 2QG
Pratima Chowdary, M.D.
- Recruiting
Central Manchester University Hospitals
Manchester, Lancashire
Foulkes Matt, +44 (0)161 901 4565, Matt.Foulkes@cmft.nhs.uk
Davies Carolyn, +44 (0)161 701 4353, clinical.trials@cmft.nhs.uk
- Recruiting
Churchill Hospital, Oxford
Oxford, OX3 7LE
Simon Fletcher, +44 1865 225316, Simon.Fletcher@ouh.nhs.uk
Paul Giangrande, M.D.
- Recruiting
Royal Cornwall Hospital, Department of Haematology
Truro, Cornwall, TR1 3LJ
Bianca Mills, 01872 252527, bianca.mills@rcht.cornwall.nhs.uk
Desmond Creagh
Ukraine6 sites, 6 recruiting
- Recruiting
Dnepropetrovsk City Clinical Hospital
Dnipro, 49102
Y Shinkarenko, M.D.
- Recruiting
Institute of Urgent and Reconstructive surgery named after V.K. Gusak of National Academy of Medical Sciences of Ukraine
Donetsk
Ekaterina Vilchevska
- Recruiting
Kharkov Regional Clinical Oncology Center
Kharkiv, 61070
Tetyana Poposvka, M.D.
- Recruiting
Kyiv City Clinical Hospital No 91
Kyiv
Ievgenii Averianov
- Recruiting
Institute of Blood Pathology and Transfusion Medicine of National Academy of Medical Sciences of Ukraine Department of Surgery and Clinical Transfusiology
Lviv
Oleksandra Stasyshyn
- Recruiting
Zaporizhzhya Region Clinical Child Hospital
Zaporzhye, 69063
A Borodin, M.D.
Russia5 sites, 5 recruiting
- Recruiting
Barnaul Altai State Scientfic Center
Barnaul, 4656024
A Mamaev, M.D.
- Recruiting
Kirov Research Institute of Hematology and Blood Transfusion
Kirov, 610027
M Timofeeva, M.D.
- Recruiting
Ismailov City Children's Clinical Hospital of Board of Health of Moscow City
Moscow, 105077
Vladimir Vdovin, M.D.
- Recruiting
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, 443099
Igor Davydkin, M.D.
- Recruiting
Ufa Republican Clinical Hospital
Ufa, 450005
G Gaysarova, M.D.
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta
Devereux Hannah, +1 780 782 4731, hannah.devereux@biosample.ca
Bruce Ritchie
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario
Nagel Kim, NAGEL@hhsc.ca
Anthony Chan
Poland2 sites, 2 recruiting
- Recruiting
wojewodzki szpital Specjalistyczny, klinika hematologii uniwersytetu medycznego w łodzi
Łodzi
Krzysztof Chojnowski, M.D.
- Recruiting
Instytut Hematologii i Transfuzjologii
Warsaw
Marcin Pasiarski, M.D.
New Zealand1 site, 1 recruiting
- Recruiting
Research Associates, Ltd.
Christchurch, New Zealand, 8081
Carolyn Lauren, +64 3 364 0386, carolyn.lauren@cdhb.health.nz
Mark Smith, M.D.
About this study
Official title: Determination of Safety, Efficacy and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 Years of Age or Older Diagnosed With Severe Hemophilia A
The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor VIII).
- Conditions
- Hemophilia A
- Being tested
- GreenGene™ F and an approved recombinant Factor VIII product, 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™ F and an approved recombinant Factor VIII productBiological
Also called GreenGeneF, GreenGene F
one 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate < 10 mL/min
GreenGene™ FBiological
Also called GreenGeneF, 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™ FBiological
Also called GreenGeneF, 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™ FBiological
Also called GreenGeneF, 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.
| Study group | Role | What they receive |
|---|---|---|
| PK substudy | Active comparator | 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). Receives: Biological: GreenGene™ F and an approved recombinant Factor VIII product |
| 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 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 50 exposure days. Receives: Biological: GreenGene™ F |
| Surgical substudy | Experimental | 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 Receives: Biological: GreenGene™ F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subject with development of inhibitors
Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months.
Measured: evert 3 months, up to 18 months
Secondary outcomes (1)
Describe the PK profile of GreenGene™ F
AUC, AUMC, Half-life, Incremental recovery, Mean residence time (MRT), Clearance, Volume of distribution - steady state, Cmax, Tmax
Measured: Pre-dose, 0~48hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startMar 2013
- Primary completionJul 2015 (estimated)
- Study completionSep 2015 (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
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Responsible party
- Sponsor
- Investigators
- Paul LeoFrancis Giangrande, MD, Principal investigator, Oxford Haemophilic Centre and Thrombosis Unit, Churchill Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619046
- Sponsor's protocol ID
- GreenGeneF_P3
- Status last verified
- Jul 2014
- First submitted
- 31 May 2012
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Safety, Efficacy and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 Years of Age or Older Diagnosed With Severe Hemophilia A
- ClinicalTrials.gov ID
- NCT01619046
- Acronym / sponsor ID
- GreenGeneF_P3
- Conditions
- Hemophilia A
- Keywords
- GreenGene™F, Previously Treated Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Atlantic Research Group
- Study start
- Mar 2013
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 14 Jun 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 assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor VIII).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PK substudy | Active comparator | Biological: GreenGene™ F and an approved recombinant Factor VIII productA 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). |
| 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 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 50 exposure days. |
| Surgical substudy | Experimental | Biological: GreenGene™ FPeri-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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female subjects age ≥ 12 years at the time of informed consent
- Body weight ≥ 35 kg
- Diagnosed with severe hemophilia A. All subjects must have severe hemophilia A with baseline FVIII <1% activity; <0.01 IU/mL
- Have ≥ 150 previous exposure days to FVIII concentrates, as documented in the subject's medical records
- 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
Key exclusion criteria (21 listed)
- Presence at Screening of FVIII inhibitor ≥ 0.6 BU as tested with the Nijmegen modification of the Bethesda assay in either central or local laboratory
- History of FVIII inhibitor of ≥ 0.6 BU as measured using the Nijmegen modification of the Bethesda assay
- 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
- Demonstrated an inability to respond to conventional doses of FVIII therapy
- History of incremental recovery of Factor VIII <1.35% per IU/kg infused
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™ F and an approved recombinant Factor VIII productAlso: GreenGeneF, GreenGene Fone 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate < 10 mL/min | Biological | PK substudy |
| GreenGene™ FAlso: GreenGeneF, GreenGene Fintra-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 | Biological | Prophylaxis safety and efficacy substudy |
| GreenGene™ FAlso: GreenGeneF, GreenGene Fintra-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 | Biological | On-demand safety and efficacy substudy |
| GreenGene™ FAlso: GreenGeneF, GreenGene Fintra 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. | Biological | Surgical substudy |
Primary outcome
Number of subject with development of inhibitors
Time frame: evert 3 months, up to 18 months
Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months.
1 secondary outcome
Describe the PK profile of GreenGene™ F
Time frame: Pre-dose, 0~48hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
Paul LeoFrancis Giangrande, MD principal investigator
Oxford Haemophilic Centre and Thrombosis Unit, Churchill Hospital
34 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GreenGene™ F and an approved recombinant Factor VIII product and GreenGene™ F in people with Hemophilia A, run by Green Cross Corporation at 34 sites in 7 countries.
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 17 inclusion and 21 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 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, United Kingdom, Ukraine, Russia, Canada and 2 more countries. 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 Kevin Wait (540-649-5490, kwait@atlanticresearchgroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subject with development of inhibitors (time frame: evert 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 3 Jul 2014.