This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
A Phase III, Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of Idarucizumab (BI 655075) in Patients Treated With Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure.
The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Beijing, China, 100029
- Beijing Anzhen Hospital
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Beijing, China, 100037
- Cardiovascular Institute and Fu Wai Hospital
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Beijing, China, 100034
- Peking University First Hospital
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Dalian, China, 116011
- First Affiliated Hospital of Dalian Medical University
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Guangzhou, China, 510288
- Sun yet-sen Memorial Hospital, Sun yet-sen Univesity
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Guangzhou, China, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, China, 310009
- 2nd Affiliated Hosp Zhejiang University College of Medical
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Hangzhou, China, 310014
- Zhejiang Province People's Hospital
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Nanchang, China, 330006
- The Second Affiliated Hospital to Nanchang University
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Nanjing, Jiangsu Province, China, 210029
- Jiangsu Province Hospital
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Shanghai, China, 200080
- Shanghai First People's Hospital
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Urumqi, China, 830054
- The First Affiliated Hospital of Xinjiang Medical University
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Wenzhou, China, 325000
- The First Affiliated Hospital of Wenzhou Med College
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion criteria:
- ≥ 18 years at screening.
- Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
- Currently taking dabigatran etexilate
They meet the following criteria:
- Group A: Overt bleeding judged by the physician to require a reversal agent. OR
- Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
Exclusion criteria:
Group A:
- Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
- Patients with no clinical signs of bleeding.
- Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
Group B:
- A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
- Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Group A - patients with uncontrolled or life-threatening bleeding
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Intravenous
Outros nomes:
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Experimental: Group B - patients not bleeding but requiring emergency surgery or invasive procedure
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Intravenous
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Ecarin Clotting Time
Prazo: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of ecarin clotting time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 41.26 seconds. |
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Maximum Reversal of Anticoagulant Effect of Dabigatran Based on Central Laboratory Determination of Diluted Thrombin Time
Prazo: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Maximum reversal of anticoagulant effect of dabigatran based on central laboratory determination of diluted thrombin time is reported. The maximum reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 35.54 seconds. |
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Percentage of Participants Achieving Cessation of Bleeding Within 24 Hours After Completion of Second Infusion (for Group A Only)
Prazo: Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
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Percentage of participants achieving cessation of bleeding within 24 hours after completion of second infusion for Group A is reported.
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Up to 24 hours after the completion of the second infusion on Day 1 of the treatment period.
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Number of Participants With Major Bleeding (for Group B Only) Intra-operatively and up to 24 Hours Post-surgery
Prazo: Up to 24 hours post-surgery.
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Number of participants with major bleeding (for Group B only) intra-operatively and up to 24 hours post-surgery per International Society for Thrombosis and Hemostasis (ISTH) classification is reported.
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Up to 24 hours post-surgery.
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Minimum Unbound Sum Dabigatran Concentrations Since the End of First Infusion up to 4 Hours After the Completion of the Last Infusion (Cmin,1)
Prazo: Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.
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Minimum unbound sum dabigatran concentrations since the end of first infusion up to 4 hours after the completion of the last infusion (Cmin,1) is reported.
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Just prior to the second infusion (last infusion) and 10 minutes (min), 30 min, 1 hour (h), 2 h, and 4 h after the end of the second infusion.
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Maximum Reversal of Anticoagulation as Measured by Activated Partial Thromboplastin Time (aPTT)
Prazo: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Maximum reversal of anticoagulation as measured by activated partial thromboplastin time (aPTT) is reported. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If the calculated reversal is > 100, it was set to 100. 100% ULN is 39.80 seconds. |
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Maximum Reversal of Anticoagulation as Measured by Thrombin Time (TT)
Prazo: From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Maximum reversal of anticoagulation as measured by thrombin time (TT) is reported. The reversal of anticoagulant effect of dabigatran is defined for patients with at least one post-dose coagulation test results and pre-dose result higher than 100% Upper limit of normal (ULN). Maximum reversal is calculated as 100% x (pre-dose value - post-dose value)/(pre-dose value - 100% ULN). If calculated reversal is > 100, it was set to 100. 100% ULN is 14.22 seconds. |
From the end of first infusion up to 4 hours after the completion of the second infusion on Day 1 of the treatment period.
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Numbers of Participants With Any Adverse Events - on Treatment
Prazo: Since the first infusion up until 5 days after the completion of the second infusion.
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Numbers of participants with any adverse events during on treatment period is reported.
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Since the first infusion up until 5 days after the completion of the second infusion.
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Numbers of Participants With Any Adverse Events - Including Post Treatment Period
Prazo: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Numbers of participants with any adverse events until end of study is reported.
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Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Number of Participants With Serious Adverse Events - on Treatment
Prazo: Since the first infusion up until 5 days after the completion of the second infusion.
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Number of participants with Serious adverse events during on treatment period is reported.
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Since the first infusion up until 5 days after the completion of the second infusion.
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Number of Participants With Serious Adverse Events - Including Post Treatment Period
Prazo: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Number of participants with Serious adverse events until the end of study is reported.
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Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Number of Participants With Drug-related Adverse Events - on Treatment
Prazo: Since the first infusion up until 5 days after the completion of the second infusion.
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Numbers of patients with drug-related adverse events during on treatment period is reported.
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Since the first infusion up until 5 days after the completion of the second infusion.
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Number of Participants With Drug-related Adverse Events - Including Post Treatment Period
Prazo: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Numbers of patients with drug-related adverse events until end of study is reported.
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Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Number of Participants With Immune Reaction Adverse Event - on Treatment
Prazo: Since the first infusion up until 5 days after the completion of the second infusion.
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Number of participants with immune reaction adverse event during on treatment period is reported.
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Since the first infusion up until 5 days after the completion of the second infusion.
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Number of Participants With Immune Reaction Adverse Event - Including Post Treatment Period
Prazo: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Number of participants with immune reaction adverse event until end of study is reported.
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Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Number of Participants With Thrombotic Events - on Treatment
Prazo: Since the first infusion up until 5 days after the completion of the second infusion.
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Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) during on treatment period is reported.
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Since the first infusion up until 5 days after the completion of the second infusion.
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Number of Participants With Thrombotic Events - Including Post Treatment Period
Prazo: Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Number of participants with thrombotic events (ischemic stroke, myocardial infarction, pulmonary embolism, deep vein thrombosis, systemic embolism) until end of study is reported.
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Since informed consent up to 30 days (± 7 days) after the completion of the second infusion, up to 37 days.
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
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Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1321-0019
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Plano de Análise Estatística (SAP)
- Relatório de Estudo Clínico (CSR)
Informações sobre medicamentos e dispositivos, documentos de estudo
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