- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00991939
Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)
Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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Louisiana
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New Orleans, Louisiana, Vereinigte Staaten, 70112
- Tulane University
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Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21201
- University of Maryland
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Baltimore, Maryland, Vereinigte Staaten, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Children's Hospital Boston
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Brigham & Women's Hospital
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New York
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New York, New York, Vereinigte Staaten, 10021
- Weill Medical College, Cornell University
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North Carolina
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Chapel Hill, North Carolina, Vereinigte Staaten, 27514
- University of North Carolina Hospitals
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University
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Ohio
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Cleveland, Ohio, Vereinigte Staaten, 44106
- Case Western Reserve University
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City, Oklahoma, Vereinigte Staaten, 73104
- The University Of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, Vereinigte Staaten, 15213
- University of Pittsburgh Presbyterian and Shadyside Hospital
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Washington
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Seattle, Washington, Vereinigte Staaten, 98195
- University of Washington Medical Center
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Wisconsin
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La Crosse, Wisconsin, Vereinigte Staaten, 54601
- Gundersen Clinic
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Madison, Wisconsin, Vereinigte Staaten, 53792
- University of Wisconsin
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Aktiver Komparator: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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.
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.)
Zeitfenster: 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.)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Through 1 year after study entry
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Through 1 year after study entry
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: James Bussel, MD, Weill Medical College, Cornell University
- Hauptermittler: Alvin Schmaier, MD, Case Western Reserve University
- Hauptermittler: Jodi Segal, MD, Johns Hopkins University
- Hauptermittler: Eliot Williams, MD, University of Wisconsin, Madison
- Hauptermittler: Thomas Ortel, MD, Duke University
- Hauptermittler: James George, MD, The University of Oklahoma
- Hauptermittler: Michele Lambert, MD, Children's Hospital of Philadelphia
- Hauptermittler: Bruce Sachais, MD, PHD, University of Pennsylvania
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Pathologische Prozesse
- Erkrankungen des Immunsystems
- Autoimmunerkrankungen
- Hämatologische Erkrankungen
- Blutung
- Hämorrhagische Störungen
- Blutgerinnungsstörungen
- Hautmanifestationen
- Thrombozytopenie
- Erkrankungen der Blutplättchen
- Thrombotische Mikroangiopathien
- Purpura
- Purpura, Thrombozytopenie
- Purpura, thrombozytopenisch, idiopathisch
- Physiologische Wirkungen von Arzneimitteln
- Autonome Agenten
- Agenten des peripheren Nervensystems
- Entzündungshemmende Mittel
- Antineoplastische Mittel
- Antiemetika
- Magen-Darm-Mittel
- Glukokortikoide
- Hormone
- Hormone, Hormonersatzstoffe und Hormonantagonisten
- Antineoplastische Mittel, hormonell
- Dexamethason
- Prednison
Andere Studien-ID-Nummern
- 675
- U01HL072268 (US NIH Stipendium/Vertrag)
- HL072268
- HL072033
- HL072291
- HL072196
- HL072289
- HL072248
- HL072191
- HL072299
- HL072305
- HL072274
- HL072028
- HL072359
- HL072072
- HL072355
- HL072283
- HL072346
- HL072331
- HL072290
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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