A Phase Ib/II in Patients With Acute Ischemic Stroke
2021年8月30日 更新者：NuvOx LLC
A Phase Ib/II Dose-finding Study of DDFPe in Patients With Acute Ischemic Stroke
Stroke is the fifth leading cause of death in the United States and is the leading cause of long term disability. Distinct geographic disparities in stroke mortality, with highest rates in the southeast United States including Arkansas, are known as the "stroke belt." There the average stroke mortality is ≈20% to 40% higher than the rest of the nation. Stroke is the leading cause of serious long-term disability. Between 2012 and 2030, disability and medical costs related to stroke are projected to triple, from $71.6 billion to $184.1 billion, with the majority of the projected increase in costs arising from those 65 to 79 years of age.
There are two main forms of stroke, ischemic and hemorrhagic. An ischemic stroke occurs in 85% of cases and is caused by cerebral vessel occlusion, obstructing blood flow to a portion of the brain. Currently, the only approved therapies for acute ischemic stroke are IV tissue plasminogen activator (tPA), a thrombolytic agent that clears the thrombus within the blood vessel, or intra-arterial catheter thrombectomy. Despite the availability of therapy, it reaches only approximately 7% of ischemic stroke victims in the United States5. Delay beyond the effective time window for therapy is a common reason for failure.
To reduce the devastating impact of stroke on individuals and society, the investigators continue to seek ways to improve functional recovery and limit ischemic damage in stroke patients. The potential neuroprotective agent, dodecafluoropentane emulsion (DDFPe) has recently shown strong positive effects in pre-clinical animal models of acute ischemic stroke6-11. Other perfluorocarbons have been tested in humans as potential neuroprotectants and blood substitutes yet none have been successful.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
24
段階
- フェーズ 1
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
-
-
Arkansas
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Little Rock、Arkansas、アメリカ、72205
- University of Arkansas for Medical Sciences
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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
18年～80年 (大人、高齢者)
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:
- Ages 18-80 years
- Diagnosis of AIS
- Body weight ≥ 45 kg
- NIHSS between 2 and 20
- Patient or legal authorized representative (LAR) must be willing and able to understand the study and provide written informed consent
Exclusion Criteria:
Currently pregnant or breastfeeding
- History of significantly impaired renal or hepatic function
- Hemorrhage or hemorrhagic stroke on CT scan
- Prior stroke, intracranial surgery, or major head trauma within three months prior to enrollment
- Pre-stroke modified Rankin Scale (mRS) ≥ 2
- Myocardial infarction within six (6) months prior to enrollment
- Unstable angina, New York Heart Association (NYHA) Class II or greater congestive heart failure
- Uncontrolled hypertension (SBP > 180 and/or diastolic blood pressure (DBP) > 110 mmHg)
- Known long QT syndrome or QTc > 450 milliseconds (ms) in males and > 470 ms in females
- Uncontrolled arrhythmia or history of clinically significant arrhythmia within the past six (6) months (except atrial fibrillation)
- Clinically significant chronic obstructive pulmonary disease (COPD) or other pulmonary condition that is not controlled by medication or requires oxygen frequently or continuously
- Pneumonia, bronchitis, or other acute respiratory disease
- Current anticoagulant therapy except for antiplatelet therapy (aspirin, NSAIDs) and prophylactic doses of low molecular weight heparin to prevent deep vein thrombosis. Note: tPA administered as part of subjects' therapy for AIS is allowed.
- History of allergic reaction attributed to compounds of similar chemical composition to DDFPe (see Investigator's Brochure).
- Subject has received any investigational drug within thirty (30) days prior to enrollment into the study
- Inability to comply with the study procedures
- History or evidence of any other clinically significant condition that, in the opinion of the investigator, might pose a safety risk to subjects or interfere with study procedures, evaluation, or completion
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：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：0.05 mL/kg DDFPe
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe.
At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
|
Prior to injection, DDFPe will be prepared by pharmacy staff.
DDFPe will be administered based on weight.
Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push.
The i.v.
push shall be 5-10 minutes in duration.
DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg).
他の名前：
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|
プラセボコンパレーター：0.05 mL/kg Placebo
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe.
At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
|
Prior to injection, the placebo will be prepared by pharmacy staff.
The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push.
The i.v.
push shall be 5-10 minutes in duration.
The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg).
|
|
アクティブコンパレータ：0.10 mL/kg DDFPe
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe.
At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
|
Prior to injection, DDFPe will be prepared by pharmacy staff.
DDFPe will be administered based on weight at designated doses.
Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push.
The i.v.
push shall be 5-10 minutes in duration.
DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg).
他の名前：
|
|
プラセボコンパレーター：0.10 mL/kg Placebo
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe.
At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
|
Prior to injection, the placebo will be prepared by pharmacy staff.
The placebo will be administered based on weight at designated doses.
Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push.
The i.v.
push shall be 5-10 minutes in duration.
The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg).
|
|
アクティブコンパレータ：0.17 mL/kg DDFPe
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe.
At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
|
Prior to injection, DDFPe will be prepared by pharmacy staff.
DDFPe will be administered based on weight at designated doses.
Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push.
The i.v.
push shall be 5-10 minutes in duration.
DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg).
他の名前：
|
|
プラセボコンパレーター：0.17 mL/kg Placebo
This study is a randomized, placebo controlled, blinded escalating dose study designed to determine the maximum tolerated dose to intravenous administration of DDFPe.
At each of the three dose levels 0.10, 0.17 mL/kg) six subjects will receive DDFPe and two will receive placebo.
|
Prior to injection, the placebo will be prepared by pharmacy staff.
The placebo will be administered based on weight at designated doses.
Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push.
The i.v.
push shall be 5-10 minutes in duration.
The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg).
|
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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Maximum Tolerated Dose (MTD) of DDFPe Evaluated by Number of Dose Limiting Toxicities
時間枠：12 hours after subjects have had a documented Acute Ischemic Stroke (AIS)
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The primary objective of this study is to establish the Maximum Tolerated Dose (MTD) of DDFPe given intravenously at intervals of 90 ± 10 minutes x 3 doses within 12 hours after subjects have had a documented Acute Ischemic Stroke (AIS).
The algorithm for determining the MTD is based on the number of subjects who experience a Dose Limiting Toxicity (DLT) in each cohort, as defined in the clinical protocol.
If three or more subjects who received DDFPe in an 8 subject cohort experience a DLT, the MTD will be determined to have been exceeded and further enrollment in the cohort as well as dose escalation will stop.
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12 hours after subjects have had a documented Acute Ischemic Stroke (AIS)
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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 |
|---|---|---|
|
NIHSS Assessment
時間枠：NIHSS scores were recorded at outside hospitals when appropriate and also at the study center as inside baseline NIHSS score. Repeat NIHSS scores were recorded at 2, 3.5, and 7.5 hours after drug injection and on discharge.
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The NIH Stroke Scale (NIHSS) is an assessment tool that provides a quantitative measure of stroke-related neurologic deficit.
The NIHSS is a 15-item neurologic examination.
Ratings for each item are scored on a 3- to 5-point scale with 0 as normal.
Scores range from 0 to 42, with higher scores indicating greater severity.
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NIHSS scores were recorded at outside hospitals when appropriate and also at the study center as inside baseline NIHSS score. Repeat NIHSS scores were recorded at 2, 3.5, and 7.5 hours after drug injection and on discharge.
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Modified Rankin Scale (mRS)
時間枠：mRS values were obtained on Day 7 or Day of Discharge, Day 30 and Day 90.
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The modified Rankin Scale is a measure of the degree of disability in patients who have had a stroke with 0 being no symptoms at all to 6 being death.
Thus, a higher score indicates greater severity.
|
mRS values were obtained on Day 7 or Day of Discharge, Day 30 and Day 90.
|
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：William Culp, MD、University of Arkansas
- 主任研究者：Sanjeeva Onteddu, MD、University of Arkansas
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 (実際)
2017年2月1日
一次修了 (実際)
2018年7月9日
研究の完了 (実際)
2018年7月9日
試験登録日
最初に提出
2016年11月10日
QC基準を満たした最初の提出物
2016年11月14日
最初の投稿 (見積もり)
2016年11月15日
学習記録の更新
投稿された最後の更新 (実際)
2021年9月24日
QC基準を満たした最後の更新が送信されました
2021年8月30日
最終確認日
2021年8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。
0.05 mL/kg DDFPeの臨床試験
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dong zhangまだ募集していません呼吸器 | 酸素化 | トレンデレンブルク | 肺 | 深腹膜
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Dr Cipto Mangunkusumo General Hospital積極的、募集していない
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Haisco Pharmaceutical Group Co., Ltd.完了
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Centre hospitalier de l'Université de Montréal...完了