- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00991939
Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)
Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Louisiana
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New Orleans, Louisiana, Spojené státy, 70112
- Tulane University
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- University of Maryland
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Baltimore, Maryland, Spojené státy, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Spojené státy, 02115
- Children's Hospital Boston
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Boston, Massachusetts, Spojené státy, 02115
- Brigham & Women's Hospital
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New York
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New York, New York, Spojené státy, 10021
- Weill Medical College, Cornell University
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North Carolina
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Chapel Hill, North Carolina, Spojené státy, 27514
- University of North Carolina Hospitals
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Durham, North Carolina, Spojené státy, 27710
- Duke University
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Ohio
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Cleveland, Ohio, Spojené státy, 44106
- Case Western Reserve University
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Cleveland, Ohio, Spojené státy, 44195
- Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- The University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Spojené státy, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- University of Pittsburgh Presbyterian and Shadyside Hospital
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Washington
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Seattle, Washington, Spojené státy, 98195
- University of Washington Medical Center
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Wisconsin
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La Crosse, Wisconsin, Spojené státy, 54601
- Gundersen Clinic
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Madison, Wisconsin, Spojené státy, 53792
- University of Wisconsin
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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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Aktivní komparátor: 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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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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.
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.)
Časové okno: 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.)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Through 1 year after study entry
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Through 1 year after study entry
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: James Bussel, MD, Weill Medical College, Cornell University
- Vrchní vyšetřovatel: Alvin Schmaier, MD, Case Western Reserve University
- Vrchní vyšetřovatel: Jodi Segal, MD, Johns Hopkins University
- Vrchní vyšetřovatel: Eliot Williams, MD, University of Wisconsin, Madison
- Vrchní vyšetřovatel: Thomas Ortel, MD, Duke University
- Vrchní vyšetřovatel: James George, MD, The University of Oklahoma
- Vrchní vyšetřovatel: Michele Lambert, MD, Children's Hospital of Philadelphia
- Vrchní vyšetřovatel: Bruce Sachais, MD, PHD, University of Pennsylvania
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Patologické procesy
- Onemocnění imunitního systému
- Autoimunitní onemocnění
- Hematologická onemocnění
- Krvácení
- Hemoragické poruchy
- Poruchy srážení krve
- Kožní projevy
- Trombocytopenie
- Poruchy krevních destiček
- Trombotické mikroangiopatie
- Purpura
- Purpura, trombocytopenická
- Purpura, trombocytopenická, idiopatická
- Fyziologické účinky léků
- Autonomní agenti
- Agenti periferního nervového systému
- Protizánětlivé látky
- Antineoplastická činidla
- Antiemetika
- Gastrointestinální látky
- Glukokortikoidy
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Antineoplastická činidla, Hormonální
- Dexamethason
- Prednison
Další identifikační čísla studie
- 675
- U01HL072268 (Grant/smlouva NIH USA)
- HL072268
- HL072033
- HL072291
- HL072196
- HL072289
- HL072248
- HL072191
- HL072299
- HL072305
- HL072274
- HL072028
- HL072359
- HL072072
- HL072355
- HL072283
- HL072346
- HL072331
- HL072290
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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