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

2. januar 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

8

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • University of Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Children's Hospital Boston
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham & Women's Hospital
    • New York
      • New York, New York, Forenede Stater, 10021
        • Weill Medical College, Cornell University
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • University of North Carolina Hospitals
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Foundation
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • The University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Presbyterian and Shadyside Hospital
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • University of Washington Medical Center
    • Wisconsin
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Clinic
      • Madison, Wisconsin, Forenede Stater, 53792
        • University of Wisconsin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

15 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: High dose pulse dexamethasone
Medicin: 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.
Aktiv komparator: Standard prednisone therapy
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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.
Tidsramme: From 60 days through 365 days after study entry.
From 60 days through 365 days after study entry.

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

HealthCore-NERI

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

  • Ledende efterforsker: James Bussel, MD, Weill Medical College, Cornell University
  • Ledende efterforsker: Alvin Schmaier, MD, Case Western Reserve University
  • Ledende efterforsker: Jodi Segal, MD, Johns Hopkins University
  • Ledende efterforsker: Eliot Williams, MD, University of Wisconsin, Madison
  • Ledende efterforsker: Thomas Ortel, MD, Duke University
  • Ledende efterforsker: James George, MD, The University of Oklahoma
  • Ledende efterforsker: Michele Lambert, MD, Children's Hospital of Philadelphia
  • Ledende efterforsker: Bruce Sachais, MD, PHD, University of Pennsylvania

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2010

Primær færdiggørelse (Faktiske)

1. marts 2013

Studieafslutning (Faktiske)

1. marts 2013

Datoer for studieregistrering

Først indsendt

7. oktober 2009

Først indsendt, der opfyldte QC-kriterier

7. oktober 2009

Først opslået (Skøn)

8. oktober 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. februar 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. januar 2014

Sidst verificeret

1. januar 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 675
  • U01HL072268 (U.S. NIH-bevilling/kontrakt)
  • HL072268
  • HL072033
  • HL072291
  • HL072196
  • HL072289
  • HL072248
  • HL072191
  • HL072299
  • HL072305
  • HL072274
  • HL072028
  • HL072359
  • HL072072
  • HL072355
  • HL072283
  • HL072346
  • HL072331
  • HL072290

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Immun trombocytopenisk purpura

Kliniske forsøg med Dexamethasone USP Micronized

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