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Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)

2 de enero de 2014 actualizado por: HealthCore-NERI

Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study

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 prednisone.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Actual)

8

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Estados Unidos
    • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

15 años y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: High dose pulse dexamethasone
Droga: Dexamethasone USP Micronized
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 activo: Standard prednisone therapy
Droga: Prednisone
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
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.
Periodo de tiempo: From 60 days through 365 days after study entry.
From 60 days through 365 days after study entry.

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.)
Periodo de tiempo: 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.)
Periodo de tiempo: From 60 days through 365 days after study entry
From 60 days through 365 days after study entry
The Percentage of Patients Undergoing Splenectomy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Through 365 days after study entry
Through 365 days after study entry
The Percentage of Patients Not Completing Study Therapy
Periodo de tiempo: 49 days after study entry
49 days after study entry
The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy
Periodo de tiempo: Through 1 year after study entry
Through 1 year after study entry

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

HealthCore-NERI

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2010

Finalización primaria (Actual)

1 de marzo de 2013

Finalización del estudio (Actual)

1 de marzo de 2013

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2009

Primero enviado que cumplió con los criterios de control de calidad

7 de octubre de 2009

Publicado por primera vez (Estimar)

8 de octubre de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

14 de febrero de 2014

Última actualización enviada que cumplió con los criterios de control de calidad

2 de enero de 2014

Última verificación

1 de enero de 2014

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 675
  • U01HL072268 (Subvención/contrato del NIH de EE. UU.)
  • HL072268
  • HL072033
  • HL072291
  • HL072196
  • HL072289
  • HL072248
  • HL072191
  • HL072299
  • HL072305
  • HL072274
  • HL072028
  • HL072359
  • HL072072
  • HL072355
  • HL072283
  • HL072346
  • HL072331
  • HL072290

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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