Hemophilia Non-Interventional Study Prior to SerpinPC Intervention (PRESent-5)
NCT ID: NCT05605678
Last Updated: 2025-02-07
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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TERMINATED
108 participants
OBSERVATIONAL
2022-12-09
2024-11-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Eligible Participants
All Participants diagnosed with severe HemA with or without inhibitors, moderately severe to severe HemB, or HemB with inhibitors will be enrolled and continue to receive their usual hemophilia treatment regimen under SOC therapy. Bleeding episodes and treatment data will be collected during the prospective follow up period in a diary. No intervention will be administered as part of this study.
No Intervention
This is a non-interventional study.
Interventions
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No Intervention
This is a non-interventional study.
Eligibility Criteria
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Inclusion Criteria
2. Who are capable of providing written informed consent (adolescent assent and parental/guardian consent when appropriate) for participation after reading the information and consent form and having the opportunity to discuss the study with the Investigator or their designee
3. With historically documented severe HemA (defined as factor VIII \[FVIII\] less than (\<) 0.01 International Units per milliliter (IU/mL) \[\<1 percent {%}\]), with or without inhibitors, or moderately severe to severe HemB (defined as factor IX \[FIX\] \<=0.02 IU/mL \[\<=2%\]) without inhibitors. Participants must be currently included in a prophylactic treatment program or if undergoing an on-demand treatment regimen must have had \>=6 documented acute bleeding episodes (spontaneous or traumatic) that required coagulation factor infusion during the 6 months before enrollment OR: Historically documented HemB (defined as FIX \<=0.05 IU/mL \[\<=5%\]) with inhibitors with a historical or ongoing high titer inhibitor \[\>=5 Bethesda Units/mL\] based on medical records or laboratory reports) and an ABR of \>=6 in the 6 months before enrollment
4. Who are able to use a diary to document bleeding events and associated treatment
Exclusion Criteria
2. With body weight greater than (\>)150 kilogram (kg) or body mass index \>40
3. With known current inadequate hematologic function (eg, platelet count \<100,000 per microliter \[/mcL\] and/or hemoglobin level \<10 grams per deciliter \[g/dL\], \<100 g/L), hepatic function (that is, total bilirubin \>1.5\*upper limit of normal \[ULN\] \[excluding Gilbert syndrome\], aspartate transferase and/or alanine aminotransferase levels \>3\*ULN; clinical signs or known laboratory or radiographic evidence consistent with cirrhosis of the liver) or renal function (that is, serum creatinine \>2\*ULN; based on medical records or available laboratory reports)
4. With previous deep vein thrombosis and pulmonary embolism, myocardial infarction, or stroke
5. With history of intolerance to subcutaneous injections
6. With known current uncontrolled hypertension (systolic blood pressure \>160 millimeter of mercury (mm Hg); diastolic blood pressure \>100 mm Hg; based on medical records)
7. With active cancer or requires therapy for cancer, except for basal cell carcinoma
8. With concurrent participation in an interventional clinical trial
9. With current or planned use of emicizumab
10. With prior, ongoing, or planned treatment with gene therapy for hemophilia
11. With history of or other evidence of recent alcohol or drug abuse as determined by the Investigator or their designee (in the 12 months before enrollment)
12. With known Human Immunodeficiency Virus (HIV) infection with CD4 count (or T-cell count) of \<200 cells/mcL within 24 weeks before enrollment
13. With current or planned treatment with anticoagulant or antiplatelet drugs
14. With any other significant conditions or comorbidities that, in the opinion of the Investigator or their designee, would make the participant unsuitable for enrollment
12 Years
65 Years
MALE
No
Sponsors
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Centessa Pharmaceuticals plc
INDUSTRY
ApcinteX Ltd
INDUSTRY
Responsible Party
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Locations
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University of Michigan
Ann Arbor, Michigan, United States
East Carolina univeristy
Greenville, South Carolina, United States
Centre of Haematology named after prof. R. O. Yeolian
Yerevan, Yerevan, Armenia
Royal Prince Alfred Hospital
Camperdown, Camperdown, Australia
Fundacao de Desenvolvimento da Unicamp FUNCAMP
Campina, São Paulo, Brazil
HEMOES - Centro de Hemoterapia e Hematologia do ES
Vitória, Vitória, Brazil
Hamilton Health Sciences Corporation
Hamilton, Hamilton, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
Unity Health Toronto
Toronto, Toronto, Canada
Ain Shams University
Cairo, Cairo Governorate, Egypt
Hopital Necker - Enfants Malades
Paris, Paris, France
Hospices Civils de Lyon (HCL) - Hopital Femme-Mere-Enfant (HFME)
Lyon, Rhone, France
Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CHU Hotel Dieu
Nantes, , France
University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany
Klinik fur Angiologie Hamostaseologie Haus 12 A Gerinnungssprechstunde
Berlin, State of Berlin, Germany
St. Johns Medical College
Bangalore, Bangalore, India
K J Somaiya Super Speciality Hospital & Research Centre
Mumbai, Mumbai, India
Christian Medical College & Hospital
Ludhiana, Punjab, India
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Milano, Italy
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Korczowski Bartosz, Gabinet Lekarski
Rzeszów, Podkarpackie Voivodeship, Poland
Kl Hemat Now Krwi i Trans USK
Wroclaw, Wrocław, Poland
King Edward VIII Hospital
Durban, Durban, South Africa
Phoenix Pharma (Pty) Ltd
Port Elizabeth, Eastern Cape, South Africa
Hospital Regional Universitario de Malaga Hospital Carlos Haya - Hospital Materno-Infantil
Málaga, Malaga, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
China Medical University Hospital
Taichung, Taichung, Taiwan
Chung Shan Medical University
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Ege University Hospital
Izmir, İzmir, Turkey (Türkiye)
Ege University Medical Faculty Pediatric Hospital
Izmir, , Turkey (Türkiye)
University Hospital of Wales
Cardiff, Cardiff, United Kingdom
Glasgow Royal Infirmary
Glasgow, Glasgow, United Kingdom
Barts and London School of Medicine and Dentistry
London, London, United Kingdom
Royal Free London NHS Foundation Trust
London, London, United Kingdom
Imperial College Healthcare NHS Trust
London, London, United Kingdom
Southampton General Hospital
Southampton, Southampton, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, Tyne and Wear, United Kingdom
Kent Canterbury Hospital
Canterbury, , United Kingdom
Central Manchester University Hospitals NHS Foundation Trust - Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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Other Identifiers
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AP-0105 (PRESent-5)
Identifier Type: -
Identifier Source: org_study_id
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