Initial Treatment of Patients With Immune Thrombocytopenic Purpura (ITP^2)
Initial Treatment of Patients With Immune Thrombocytopenic Purpura: The ITP^2 Study
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Tulane University
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Maryland
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Baltimore、Maryland、アメリカ、21201
- University of Maryland
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Baltimore、Maryland、アメリカ、21287
- Johns Hopkins Hospital
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Boston、Massachusetts、アメリカ、02115
- Children's Hospital Boston
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Boston、Massachusetts、アメリカ、02115
- Brigham & Women's Hospital
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New York
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New York、New York、アメリカ、10021
- Weill Medical College, Cornell University
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North Carolina
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Chapel Hill、North Carolina、アメリカ、27514
- University of North Carolina Hospitals
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Durham、North Carolina、アメリカ、27710
- Duke University
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Ohio
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Cleveland、Ohio、アメリカ、44106
- Case Western Reserve University
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73104
- The University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Children's Hospital of Philadelphia
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Presbyterian and Shadyside Hospital
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Washington
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Seattle、Washington、アメリカ、98195
- University of Washington Medical Center
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Wisconsin
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La Crosse、Wisconsin、アメリカ、54601
- Gundersen Clinic
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Madison、Wisconsin、アメリカ、53792
- University of Wisconsin
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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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アクティブコンパレータ: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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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.
時間枠: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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二次結果の測定
結果測定 |
時間枠 |
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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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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.)
時間枠: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.)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠:Through 1 year after study entry
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Through 1 year after study entry
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協力者と研究者
スポンサー
捜査官
- 主任研究者:James Bussel, MD、Weill Medical College, Cornell University
- 主任研究者:Alvin Schmaier, MD、Case Western Reserve University
- 主任研究者:Jodi Segal, MD、Johns Hopkins University
- 主任研究者:Eliot Williams, MD、University of Wisconsin, Madison
- 主任研究者:Thomas Ortel, MD、Duke University
- 主任研究者:James George, MD、The University of Oklahoma
- 主任研究者:Michele Lambert, MD、Children's Hospital of Philadelphia
- 主任研究者:Bruce Sachais, MD, PHD、University of Pennsylvania
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 675
- U01HL072268 (米国 NIH グラント/契約)
- HL072268
- HL072033
- HL072291
- HL072196
- HL072289
- HL072248
- HL072191
- HL072299
- HL072305
- HL072274
- HL072028
- HL072359
- HL072072
- HL072355
- HL072283
- HL072346
- HL072331
- HL072290
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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