- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00991939
Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)
Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane University
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Maryland
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Baltimore, Maryland, Stati Uniti, 21201
- University of Maryland
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Baltimore, Maryland, Stati Uniti, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Stati Uniti, 02115
- Children's Hospital Boston
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Boston, Massachusetts, Stati Uniti, 02115
- Brigham & Women's Hospital
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New York
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New York, New York, Stati Uniti, 10021
- Weill Medical College, Cornell University
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27514
- University of North Carolina Hospitals
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Durham, North Carolina, Stati Uniti, 27710
- Duke University
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Case Western Reserve University
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Cleveland, Ohio, Stati Uniti, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73104
- The University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, Stati Uniti, 15213
- University of Pittsburgh Presbyterian and Shadyside Hospital
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Washington
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Seattle, Washington, Stati Uniti, 98195
- University of Washington Medical Center
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Wisconsin
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La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Clinic
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Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: High dose pulse dexamethasone
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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.
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Comparatore attivo: Standard prednisone therapy
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
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.
Lasso di tempo: From 60 days through 365 days after study entry.
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From 60 days through 365 days after study entry.
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
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
Lasso di tempo: From 60 days through 365 days after study entry
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From 60 days through 365 days after study entry
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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
Lasso di tempo: 365 days after study entry
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365 days after study entry
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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
Lasso di tempo: From 180 days through 365 days after study entry
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From 180 days through 365 days after study entry
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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
Lasso di tempo: From 180 days through 365 days after study entry
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From 180 days through 365 days after study entry
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The Percentage of Patients Receiving Acute Therapeutic Intervention During the First 60 Days After Study Entry
Lasso di tempo: Through 60 days after study entry
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Through 60 days after study entry
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The Percentage of Patients Receiving Acute Therapeutic Intervention Beyond the First 60 Days After Study Entry
Lasso di tempo: From 60 days through 365 days after study entry
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From 60 days through 365 days after study entry
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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.)
Lasso di tempo: From 60 days through 365 days after study entry
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From 60 days through 365 days after study entry
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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.)
Lasso di tempo: From 60 days through 365 days after study entry
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From 60 days through 365 days after study entry
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The Percentage of Patients Undergoing Splenectomy
Lasso di tempo: Through 365 days after study entry
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Through 365 days after study entry
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Change in the Quality of Life From Randomization to Weeks 4, 8 and End of Study, Determined Using the SF-36 Health Survey
Lasso di tempo: Weeks 4, 8, and 52 after study entry
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Weeks 4, 8, and 52 after study entry
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The Incidence and Severity of Bleeding as Defined by a Customized Bleeding Score
Lasso di tempo: Through 365 days after study entry
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Through 365 days after study entry
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The Percentage of Patients Not Completing Study Therapy
Lasso di tempo: 49 days after study entry
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49 days after study entry
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The Percentage of Patients With Severe Adverse Events Attributable to Steroid Therapy
Lasso di tempo: Through 1 year after study entry
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Through 1 year after study entry
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: James Bussel, MD, Weill Medical College, Cornell University
- Investigatore principale: Alvin Schmaier, MD, Case Western Reserve University
- Investigatore principale: Jodi Segal, MD, Johns Hopkins University
- Investigatore principale: Eliot Williams, MD, University of Wisconsin, Madison
- Investigatore principale: Thomas Ortel, MD, Duke University
- Investigatore principale: James George, MD, The University of Oklahoma
- Investigatore principale: Michele Lambert, MD, Children's Hospital of Philadelphia
- Investigatore principale: Bruce Sachais, MD, PHD, University of Pennsylvania
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Processi patologici
- Malattie del sistema immunitario
- Malattie autoimmuni
- Malattie ematologiche
- Emorragia
- Disturbi emorragici
- Disturbi della coagulazione del sangue
- Manifestazioni cutanee
- Trombocitopenia
- Disturbi delle piastrine del sangue
- Microangiopatie trombotiche
- Porpora
- Porpora, Trombocitopenica
- Porpora, Trombocitopenica, Idiopatica
- Effetti fisiologici delle droghe
- Agenti autonomi
- Agenti del sistema nervoso periferico
- Agenti antinfiammatori
- Agenti antineoplastici
- Antiemetici
- Agenti gastrointestinali
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, ormonali
- Desametasone
- Prednisone
Altri numeri di identificazione dello studio
- 675
- U01HL072268 (Sovvenzione/contratto NIH degli Stati Uniti)
- HL072268
- HL072033
- HL072291
- HL072196
- HL072289
- HL072248
- HL072191
- HL072299
- HL072305
- HL072274
- HL072028
- HL072359
- HL072072
- HL072355
- HL072283
- HL072346
- HL072331
- HL072290
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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