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De klinische studie NCT07406139 (2022PCC-A) voor Hemofilie, Inhibitors is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag.
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PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） Fase 4 30

Rekruterend
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De klinische studie NCT07406139 (2022PCC-A) onderzoekt behandeling bij Hemofilie, Inhibitors. Deze Fase 4 interventioneel-studie heeft de status rekruterend. Het doel is om 30 deelnemers te includeren vanaf 1 maart 2026. De studie wordt geleid door Institute of Hematology & Blood Diseases Hospital, China en de voltooiing is gepland op 20 december 2026. Laatste update op ClinicalTrials.gov: 12 februari 2026.
Beknopte samenvatting
This study is a multicenter, prospective, single-arm exploratory clinical trial designed to evaluate the efficacy and safety of prothrombin complex concentrate (PCC) in the treatment of bleeding episodes in patients with hemophilia A with inhibitors. All participants received on-demand PCC therapy during bleeding episodes, with dosing adjusted by investigators according to the type of bleeding. The recommended dose w...Toon meer
Uitgebreide beschrijving
Hemophilia A is a severe and common hereditary bleeding disorder caused by a deficiency of coagulation factor VIII (FVIII). Recurrent bleeding episodes, if not treated promptly, can lead to joint deformities or pseudotumor formation and may even be life-threatening in severe cases. In recent years, with the widespread use of plasma-derived and recombinant FVIII products, the management of hemophilia A has made signif...Toon meer
Officiële titel

A Multicenter, Prospective, Single-arm Exploratory Study of Prothrombin Complex Concentrate in the Treatment of Bleeding Episodes in Patients With Hemophilia A With Inhibitors

Aandoeningen
HemofilieInhibitors
Andere studie-ID's
  • 2022PCC-A
  • IIT2022048
NCT-ID
NCT07406139
Startdatum (Werkelijk)
2026-03-01
Laatste update geplaatst
2026-02-12
Verwachte einddatum
2026-12-20
Inschrijving (Geschat)
30
Studietype
Interventioneel
FASE
Fase 4
Status
Rekruterend
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelPCC treatment
PCC
On-demand PCC therapy during bleeding episodes. The recommended dose was 50 IU/kg per infusion, administered every 8-12 hours, with a maximum total daily dose not exceeding 150 IU/kg.
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Efficacy of prothrombin complex concentrate (PCC) in the treatment of bleeding episodes in patients with hemophilia A with inhibitors.
Hemostatic Efficacy Rate: Bleeding symptoms were evaluated at 8 hours and 24 hours after treatment. The assessment of hemostatic response included four categories: excellent, good, moderate, and ineffective.
From enrollment to the end of treatment at 24 hours
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
To evaluate the improvement score of bleeding symptoms and signs within 24 hours after the first infusion of prothrombin complex concentrate (PCC) for each bleeding episode in patients with hemophilia A with inhibitors.
From enrollment to the end of treatment at 24 hours
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Kind, Volwassene, Oudere volwassene
Minimumleeftijd
12 Years
Geslachten die in aanmerking komen voor de studie
Allen
  1. Diagnosed with hemophilia A with inhibitors. For high-responding patients (those who have previously had an inhibitor titer >5 BU), the inhibitor titer at enrollment must be >0.6 BU;
  2. Age between 12 and 65 years;
  3. At least three joint bleeding episodes within the past six months;
  4. Signed informed consent form.

  1. Presence of other congenital or acquired bleeding disorders;
  2. Liver function tests (ALT, AST) >2.5 times the upper limit of normal, or renal function tests (BUN, Cr) >1.5 times the upper limit of normal;
  3. Currently receiving immune tolerance induction (ITI) therapy with an inhibitor titer <5 BU;
  4. History of thrombotic events;
  5. Known history of drug allergy, asthma, urticaria, or other allergic conditions;
  6. Deemed unsuitable for study participation by the investigator.
Institute of Hematology & Blood Diseases Hospital, China logoInstitute of Hematology & Blood Diseases Hospital, China
Centraal Contactpersoon
Contact: Mankai Ju, +8615620988690, [email protected]
Contact: Feng Xue, +862223608174, [email protected]
1 Studielocaties in 1 landen

Tianjin Municipality

Institute of haematology and Blood diseases hospital, Tianjin, Tianjin Municipality, 300020, China
Mankai Ju, Contact, +8615620988690, [email protected]
Lei Zhang, Contact, 2223608177, [email protected]
Rekruterend