- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00991939
Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)
Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
ITP is a common disorder associated with significant morbidity. For more than 40 years it has been recognized that this disorder was responsive to corticosteroid therapy. As corticosteroids are easily obtainable and inexpensive, they have become the standard first-line therapy for adult patients with newly-diagnosed ITP. Generally, patients are treated with prednisone at a dose of approximately 1 mg/kg, or 60 mg/day, and once a response is obtained the daily dosage is gradually tapered. While approximately 70% of patients treated in this manner respond initially, most will relapse as the corticosteroid dose is lowered; ultimately only 15-20% of patients achieve a complete or partial remission of their ITP at an "acceptable" dose of prednisone. Recently, several studies have suggested that the use of high dose corticosteroids, specifically pulse dexamethasone, may be a more efficacious initial therapy for ITP, capable of causing a higher initial response rate and a significantly longer duration of remission despite a shorter course of initial therapy.
This study will compare treatment with 3 courses of high-dose dexamethasone versus treatment with prednisone, for patients recently diagnosed with immune thrombocytopenic purpura (ITP). The primary hypothesis is that patients treated with high-dose dexamethasone will obtain a more durable remission than patients treated with standard oral corticosteroids. This may reflect the ability of high dose corticosteroids to eradicate a sensitive pathogenic lymphoid clone that may be transiently susceptible to aggressive immunosuppressive therapy early in the course of disease.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
Louisiana
-
New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21201
- University of Maryland
-
Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital Boston
-
Boston, Massachusetts, Estados Unidos, 02115
- Brigham & Women's Hospital
-
-
New York
-
New York, New York, Estados Unidos, 10021
- Weill Medical College, Cornell University
-
-
North Carolina
-
Chapel Hill, North Carolina, Estados Unidos, 27514
- University of North Carolina Hospitals
-
Durham, North Carolina, Estados Unidos, 27710
- Duke University
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Foundation
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Estados Unidos, 73104
- The University of Oklahoma Health Sciences Center
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Presbyterian and Shadyside Hospital
-
-
Washington
-
Seattle, Washington, Estados Unidos, 98195
- University of Washington Medical Center
-
-
Wisconsin
-
La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Clinic
-
Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Must meet criteria for a diagnosis of ITP as specified by ASH guidelines
- Must be within 30 days after diagnosis of ITP at the time of randomization (diagnosis of ITP starts with first platelet count ≤ 100,000/μl)
- Platelet count ≤ 30,000/μl at the time ITP is diagnosed, and/or at some time between the diagnosis of ITP and study entry
- Platelet count ≤ 150,000/μl at the time of randomization
- Age ≥ 15 years
- If bone marrow examination is available, it must be compatible with ITP
- Subjects, or their legal guardians, must have the ability to provide informed consent
Exclusion Criteria:
- Rituximab therapy or splenectomy for ITP or for any other cause within the previous 8 weeks.
- Known HIV infection
- Known HCV infection
- Known systemic lupus erythematosus
- Pregnancy or breastfeeding
- Insulin-requiring diabetes mellitus
- Previous exposure to prednisone for ITP at a dose ≥ 1.5 mg/kg prednisone/day for ≥ 1 week prior to study entry
- Ongoing use of treatments that are known to inhibit platelet function, e.g. aspirin
- Anything that in the opinion of the investigator is likely to interfere with participation in the study
- Persons previously randomized in the ITP^2 study
- Persons currently enrolled in other interventional clinical trials
- Exposure to thrombopoietic agent prior to study entry
- Previous exposure to dexamethasone for the treatment of ITP at a dose of 30 mg/day or greater for subjects < 60 kg or 40 mg/day or greater for subjects >= 60 kg for at least four days
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: High dose pulse dexamethasone
|
The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg.
The patient will be dosed on days 1-4, 15-18 and 29-32.
On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
|
Comparador Ativo: Standard prednisone therapy
|
Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days.
The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped.
Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
The Percentage of Patients in Each Treatment Arm Who Remain Free of All ITP Therapy With a Platelet Count ≥ 50,000/μl From 60 Days Through 365 Days After Study Entry.
Prazo: From 60 days through 365 days after study entry.
|
From 60 days through 365 days after study entry.
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count ≥ 150,000/μl From 60 Days Through 365 Days After Study Entry
Prazo: From 60 days through 365 days after study entry
|
From 60 days through 365 days after study entry
|
The Percentage of Patients With Platelets ≥ 50,000/μl at 365 Days Who Are Off All Treatment, Have Received ≤ 2 Acute Therapeutic Interventions for Thrombocytopenia, and Whose Last Acute Therapeutic Intervention Occurred at Least 90 Days Before Day 365
Prazo: 365 days after study entry
|
365 days after study entry
|
The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 150,000 From 180 Through 365 Days After Study Entry
Prazo: From 180 days through 365 days after study entry
|
From 180 days through 365 days after study entry
|
The Percentage of Patients Who Remain Free of All ITP Therapy With a Platelet Count of ≥ 50,000 From 180 Through 365 Days After Study Entry
Prazo: From 180 days through 365 days after study entry
|
From 180 days through 365 days after study entry
|
The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry
Prazo: Through 60 days after study entry
|
Through 60 days after study entry
|
The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry
Prazo: From 60 days through 365 days after study entry
|
From 60 days through 365 days after study entry
|
The Percentage of Platelet Counts ≥ 50,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)
Prazo: From 60 days through 365 days after study entry
|
From 60 days through 365 days after study entry
|
The Percentage of Platelet Counts ≥ 150,000/μl After Day 60 (If a Subject Receives an Acute Therapeutic Intervention, the Next Protocol-specified Platelet Count Will be Excluded From This Analysis, as it May be Influenced by the Intervention.)
Prazo: From 60 days through 365 days after study entry
|
From 60 days through 365 days after study entry
|
The Percentage of Patients Undergoing Splenectomy
Prazo: Through 365 days after study entry
|
Through 365 days after study entry
|
Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey
Prazo: Weeks 4, 8, and 52 after study entry
|
Weeks 4, 8, and 52 after study entry
|
The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score
Prazo: Through 365 days after study entry
|
Through 365 days after study entry
|
The Percentage of Patients Not Completing Study Therapy
Prazo: 49 days after study entry
|
49 days after study entry
|
The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy
Prazo: Through 1 year after study entry
|
Through 1 year after study entry
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: James Bussel, MD, Weill Medical College, Cornell University
- Investigador principal: Alvin Schmaier, MD, Case Western Reserve University
- Investigador principal: Jodi Segal, MD, Johns Hopkins University
- Investigador principal: Eliot Williams, MD, University of Wisconsin, Madison
- Investigador principal: Thomas Ortel, MD, Duke University
- Investigador principal: James George, MD, The University of Oklahoma
- Investigador principal: Michele Lambert, MD, Children's Hospital of Philadelphia
- Investigador principal: Bruce Sachais, MD, PHD, University of Pennsylvania
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças do sistema imunológico
- Doenças autoimunes
- Doenças Hematológicas
- Hemorragia
- Distúrbios hemorrágicos
- Distúrbios da Coagulação Sanguínea
- Manifestações de pele
- Trombocitopenia
- Distúrbios das plaquetas sanguíneas
- Microangiopatias Trombóticas
- Púrpura
- Púrpura Trombocitopênica
- Púrpura Trombocitopênica Idiopática
- Efeitos Fisiológicos das Drogas
- Agentes Autônomos
- Agentes do Sistema Nervoso Periférico
- Antiinflamatórios
- Agentes Antineoplásicos
- Antieméticos
- Agentes gastrointestinais
- Glicocorticóides
- Hormônios
- Hormônios, Substitutos Hormonais e Antagonistas Hormonais
- Agentes Antineoplásicos Hormonais
- Dexametasona
- Prednisona
Outros números de identificação do estudo
- 675
- U01HL072268 (Concessão/Contrato do NIH dos EUA)
- HL072268
- HL072033
- HL072291
- HL072196
- HL072289
- HL072248
- HL072191
- HL072299
- HL072305
- HL072274
- HL072028
- HL072359
- HL072072
- HL072355
- HL072283
- HL072346
- HL072331
- HL072290
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Dexamethasone USP Micronized
-
University of ChicagoCapnia, Inc.Concluído
-
GE HealthcareLaboratory Corporation of AmericaConcluídoEstudo para determinar a dosagem de OPTISON em crianças entre ≥9 eEstados Unidos
-
Indiana UniversityConcluídoCâncer cervical | Câncer do endométrioEstados Unidos
-
Restorix Research Institute, LLLPCytomedix; Island HospitalDesconhecidoMudanças nos Números e Tipos da População de Sangue Periférico.Estados Unidos
-
Amneal Pharmaceuticals, LLCSymbio, LLCConcluídoInfecções não complicadas do trato urinárioEstados Unidos
-
B. Braun Medical Inc.Concluído
-
GE HealthcareRescindidoDoença da Artéria CarótidaEstados Unidos
-
OPKO Health, Inc.ConcluídoTraumatismo crânianoEstados Unidos
-
B. Braun Medical Inc.ParexelConcluído
-
Shanghai University of Traditional Chinese MedicineDesconhecidoArtrite reumatoide | Massa linfonodal | Vaso linfático; DilataçãoChina