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O estudo clínico NCT07406139 (2022PCC-A) para Hemofilia, Inhibitors está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.
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PCC Treatment for Hemophilia Patients With Inhibitor（2022PCC-A） Fase IV 30

Em recrutamento
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07406139 (2022PCC-A) procura avaliar tratamento para Hemofilia, Inhibitors. Este é um estudo intervencionista de Fase IV. Seu status atual é: em recrutamento. O estudo começou em 1 de março de 2026 e pretende incluir 30 participantes. Coordenado por Institute of Hematology & Blood Diseases Hospital, China e deve ser concluído em 20 de dezembro de 2026. Essas informações foram atualizadas no ClinicalTrials.gov em 12 de fevereiro de 2026.
Resumo
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...Mostrar mais
Descrição detalhada
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...Mostrar mais
Título oficial

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

Condições médicas
HemofiliaInhibitors
Outros IDs do estudo
  • 2022PCC-A
  • IIT2022048
Número NCT
NCT07406139
Data de início (real)
2026-03-01
Última atualização postada
2026-02-12
Data de conclusão (estimada)
2026-12-20
Inscrição (estimada)
30
Tipo de estudo
Intervencionista
FASE
Fase IV
Status
Em recrutamento
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
Grupo de participantes/BraçoIntervenção/Tratamento
ExperimentalPCC 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.
Desfecho primário
Medida de desfechoDescrição da medidaPrazo
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
Desfecho secundário
Medida de desfechoDescrição da medidaPrazo
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
Assistente de participação
Critérios de elegibilidade

Idades elegíveis
Criança, Adulto, Idoso
Idade mínima
12 Years
Sexos elegíveis
Todos
  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
Contato central do estudo
Contato: Mankai Ju, +8615620988690, [email protected]
Contato: Feng Xue, +862223608174, [email protected]
1 Locais do estudo em 1 países

Tianjin Municipality

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