Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
2012年1月25日 更新者：ZymoGenetics
A Phase 4, Open-Label, Single-Group Safety and Immunogenicity Study of RECOTHROM® (rThrombin) in Pediatric Subjects Undergoing Synchronous Burn Wound Excision and Skin Grafting
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through 17 years of age.
調査の概要
詳細な説明
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in 5 Phase 2 studies, 1 pivotal Phase 3 study, and 1 Phase 3b study, in surgical indications such as: spinal surgery, major hepatic resection, peripheral arterial bypass surgery, arteriovenous graft formation for hemodialysis access, and burn wound excision.
Limited data currently exist on the effects of rThrombin exposure in pediatric patients.
This Phase 4 trial aims to provide additional information on the use of rThrombin in children by evaluating the drug's safety and immunogenicity when administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric burn patients.
研究の種類
介入
入学 (実際)
30
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85008
- Arizona Burn Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
17年歳未満 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Age of newborn through 17 years at time of enrollment
- At least 1 skin graft recipient site measuring at least 1% of total body surface area (TBSA)
- Total initial burn wounds estimated to measure less than 40% of TBSA
- Bleeding indicating treatment with rThrombin during the surgical procedure
- Females of child-bearing potential must have a negative urine or serum pregnancy test within 2 days prior to study-drug treatment
- informed consent document signed by legal representative (guardian) and approved by an institutional review board/independent ethics committee (IRB/IEC)
- Participant has signed an IRB/IEC-approved pediatric assent document, if applicable
Exclusion Criteria:
- Gestational age younger than 36 weeks at birth (for infants younger than 2 years)
- Documented active infection at the graft recipient site (participants with resolved infections at potential graft recipient sites are not excluded)
- Acute inhalation injury, as defined by bronchoscopic evidence of lower airway injury
- Currently undergoing autologous skin grafting for ischemic ulcer disease or cutaneous malignancies
- Presence of antibodies or hypersensitivity to the study drug or any of its components, other thrombin preparations, or coagulation factors
- Transfusion of whole blood, fresh frozen plasma, cryoprecipitate, or platelets within 24 hours prior to study-drug treatment (packed red blood cell transfusions are allowed)
- History of HIV infection or other immunodeficiency syndrome or is taking immunosuppressive or antirejection medications
- Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect safety or compliance with study procedures
- Breastfeeding or being breastfed
- Treatment with any experimental agent within 30 days of study enrollment or treatment
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：Recombinant thrombin (rThrombin), 1000 IU/mL
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rThrombin,1000 IU/mL, 1000 IU/mL, applied topically to the bleeding site during a single surgery procedure on Day 1.
他の名前：
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity
時間枠：Days 1 through 29, continuously
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An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.
An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment
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Days 1 through 29, continuously
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Number of Participants With AEs by Maximum Severity
時間枠：Days 1 through 29, continuously
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An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.
Mild=asymptomatic or minor symptoms; intervention not indicated.
Moderate=requiring only minimal, local, or noninvasive intervention.
Severe=significant symptoms but not life-threatening; hospitalization or invasive intervention indicated.
Life-threatening=indicating intensive care or urgent invasive intervention.
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Days 1 through 29, continuously
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Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts
時間枠：Baseline and Day 29 from Baseline
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Abnormal laboratory findings were recorded as AEs when considered clinically significant (unusual for the surgical population or individual participant) by the investigator, when associated with symptoms, when requiring specific treatment, or when requiring a change in participant management.LLN=lower level of normal.
Platelets: Grade 0=normal.
WBC: Grade 0=normal.
Lymphocytes: Grade 0=normal; Grade 1=<LLN x 0.8-10^9/L.
Neutrophils: Grade 0=normal; Grade 1=<LLN-1.5x10^9/L;
Grade 2=<1.5-1.0x10^9/L
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Baseline and Day 29 from Baseline
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Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels
時間枠：Baseline and Day 29 from Baseline
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LLN=lower level of normal.
Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.
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Baseline and Day 29 from Baseline
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Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels
時間枠：Baseline and Day 29 from Baseline
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ULN=upper level of normal.
Grade 0=normal; Grade 1=>ULN to 1.5 x ULN.
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Baseline and Day 29 from Baseline
|
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Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher
時間枠：Baseline and Day 29 from Baseline
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ULN=upper limit of normal.
Grade 0=normal; Grade 1=ULN to 1.5 x ULN.
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Baseline and Day 29 from Baseline
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Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher
時間枠：Baseline and Day 29 from Baseline
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Grade 0=normal.
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Baseline and Day 29 from Baseline
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody
時間枠：At Day 29
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Antibody-positive was defined as seroconversion or ≥1.0 unit (≥10-fold) increase in titer compared with antibody titer at baseline.
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At Day 29
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Kevin Foster, MD、Arizona Burn Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年3月1日
一次修了 (実際)
2010年1月1日
研究の完了 (実際)
2010年1月1日
試験登録日
最初に提出
2009年3月9日
QC基準を満たした最初の提出物
2009年3月10日
最初の投稿 (見積もり)
2009年3月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年1月26日
QC基準を満たした最後の更新が送信されました
2012年1月25日
最終確認日
2012年1月1日
詳しくは
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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