IA Trial Radar
L'essai clinique NCT07406139 (2022PCC-A) pour Hémophilie, Inhibitors est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici.
Un essai clinique correspond aux filtres sélectionnés
Vue en carte
Retour à la recherche

PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） Phase IV 30

En recrutement
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT07406139 (2022PCC-A) est conçu pour étudier le traitement de Hémophilie, Inhibitors. Il s'agit d'une étude interventionnel en Phase IV. Son statut actuel est : en recrutement. L'étude a débuté le 1 mars 2026 et vise à recruter 30 participants. Dirigée par Institute of Hematology & Blood Diseases Hospital, China, l'étude devrait être terminée d'ici le 20 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 12 février 2026.
Résumé succinct
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...Afficher plus
Description détaillée
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...Afficher plus
Titre officiel

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

Pathologies
HémophilieInhibitors
Autres identifiants de l'étude
  • 2022PCC-A
  • IIT2022048
Numéro NCT
NCT07406139
Date de début (réel)
2026-03-01
Dernière mise à jour publiée
2026-02-12
Date de fin (estimée)
2026-12-20
Inscription (estimée)
30
Type d'étude
Interventionnel
PHASE
Phase IV
Statut
En recrutement
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
ExpérimentalPCC 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.
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
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
Assistant à la participation
Critères d'éligibilité

Âges éligibles
Enfant, Adulte, Adulte âgé
Âge minimum
12 Years
Sexes éligibles
Tous
  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
Contact central de l'étude
Contact: Mankai Ju, +8615620988690, [email protected]
Contact: Feng Xue, +862223608174, [email protected]
1 Centres de l'étude dans 1 pays

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]
En recrutement