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Effects of the V1a Agonist FE 202158 in Patients With Septic Shock

2017年8月24日 更新者：Ferring Pharmaceuticals

Infusion Proof-of-concept Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of FE 202158 in Patients With Vasodilatory Hypotension in Early Septic Shock

The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This was a multi-centre, double-blind, randomized, placebo-controlled, parallel group trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of FE 202158 (using three ascending doses) in patients with vasodilatory hypotension in early septic shock, when given as continuous infusion for up to 7 days.

The trial comprised of three treatment arms where FE 202158 was administered in 1.25 ng, 2.5 ng and 3.75 ng dose, respectively. A placebo arm was also included in the trial where patients received isotonic saline.

Efficacy of FE 202158 was determined by evaluating its ability to maintain mean arterial pressure (MAP) >60 mmHg and its modulating effect on inflammatory markers. Effects of FE 202158 on other variables like vital signs, morbidity, mortality and pulmonary function were also determined.

研究の種類

介入

入学 (実際)

53

段階

  • フェーズ2

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

  • アメリカ
    • Delaware
      • Newark、Delaware、アメリカ
        • Christiana Care Health System
    • Massachusetts
      • Springfield、Massachusetts、アメリカ
        • Baystate Medical Center
    • Minnesota
      • Duluth、Minnesota、アメリカ
        • Division of Education and Research SMDC Health System
    • New Jersey
      • Camden、New Jersey、アメリカ
        • Cooper University Hospital
    • New York
      • New York、New York、アメリカ
        • Mount Sinai School of Medicine
    • Texas
      • Houston、Texas、アメリカ
        • Baylor College of Medicine
  • カナダ
      • Vancouver、カナダ
        • Royal Columbian Hospital
      • Vancouver、カナダ
        • St. Paul´s Hospital
  • デンマーク
      • Bispebjerg、デンマーク
        • Bispebjerg Hospital
      • Copenhagen、デンマーク
        • Rigshospitalet
      • Hillerød、デンマーク
        • Hillerød Hospital
      • Hvidovre、デンマーク
        • Hvidovre Hospital
  • ベルギー
      • Brussels、ベルギー
        • Clinique Universitaire St-Luc
      • Brussels、ベルギー
        • Erasme Hospital (Free University of Brussels)
      • Brussels、ベルギー
        • University Hospital Vrije Universiteit
      • Dinant、ベルギー
        • Service des Soins Intensits

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年歳以上 (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:

  • Signed informed consent form by the patient or a legal representative according to local regulations
  • Man or woman 18 years of age or older
  • Proven or suspected infection
  • Low blood pressure
  • Signs of decreased circulation in the tissues
  • Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from the day of informed consent to one week after the end of infusion of study medication.

Exclusion Criteria:

  • Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible.
  • Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test.
  • Known or suspected cardiac failure
  • Pregnancy or breastfeeding
  • Any cause of hypotension other than early septic shock
  • Use of vasopressin or terlipressin for blood pressure support during the current hospital admission
  • Proven or suspected acute mesenteric ischemia, as judged by the investigator
  • Known episode of septic shock within 1 month prior to randomisation
  • Underlying chronic heart disease
  • Traumatic brain injury
  • Present hospitalisation with burn injury
  • Symptomatic peripheral vascular disease including Raynaud's syndrome
  • Previously randomized in this trial
  • Intake of an investigational drug within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
  • Known participation in another clinical trial
  • Considered by the investigator to be unsuitable to participate in the trial for any other reason

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
実験的：FE 202158 1.25

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
薬：FE 202158 1.25
FE 202158 at dose 1.25 ng/kg/min infused.
実験的：FE 202158 2.5

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
薬：FE 202158 2.5
FE 202158 at dose 2.5 ng/kg/min infused.
実験的：FE 202158 3.75

Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.

FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
薬：FE 202158 3.75
FE 202158 at dose 3.75 ng/kg/min infused.
プラセボコンパレーター：PLCBO
Patients in the arm received an intravenous infusion for up to 7 days of placebo.
他の：Placebo
Isotonic saline infused.

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
Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)
時間枠：Day 1 up to Day 7

Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE
時間枠：Day 1 up to Day 7

Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Cumulative Dose of Open Label NE.
時間枠：Day 1 up to Day 7

Cumulative Dose of Open Label NE over 7 days.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Infusion Rates of Open Label NE.
時間枠：Day 1 up to Day 7

Mean open label NE infusion rate within each predefined time period.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7

二次結果の測定

結果測定
メジャーの説明
時間枠
Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration
時間枠：Day 1 up to Day 7

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
PK Parameter in Patients : Time to Steady State
時間枠：Day 1 up to Day 7

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
PK Parameter in Patients : Clearance
時間枠：Day 1 up to Day 7

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
PK Parameter in Patients : Steady State Volume of Distribution
時間枠：Day 1 up to Day 7

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
PK Parameter in Patients : Initial Elimination Half-life
時間枠：Day 1 up to Day 7

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
PK Parameter in Patients : Terminal Elimination Half-life
時間枠：Day 1 up to Day 7

PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Change From Baseline in C-reactive Protein (CRP)
時間枠：Day 1 up to Day 7

The change from Baseline in CRP levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha
時間枠：At Day 1, Day 2, Day 4, and Day 7

The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 1, Day 2, Day 4, and Day 7
Change From Baseline in Interleukin-6 (IL-6)
時間枠：At Day 1, Day 2, Day 4, and Day 7

The change from Baseline in IL-6 levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 1, Day 2, Day 4, and Day 7
Change From Baseline in Interleukin-10 (IL-10)
時間枠：At Day 1, Day 2, Day 4, and Day 7

The change from Baseline in IL-10 levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 1, Day 2, Day 4, and Day 7
Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist
時間枠：At Day 1, Day 2, Day 4, and Day 7

The change from Baseline in IL-1R levels were analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 1, Day 2, Day 4, and Day 7
Change From Baseline in Heart Rate
時間枠：Day 1 up to Day 7

The change from Baseline in heart rate was analysed and presented as per the planned time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Change From Baseline in Fluid Balance
時間枠：Day 1 up to Day 7

The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
SOFA Score
時間枠：Day 1 up to Day 7, Day 14 and Day 29

The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst).

Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7, Day 14 and Day 29
Pulmonary Function : Change From Baseline in PaO2/FiO2
時間枠：Day 1 up to Day 7

Change from Baseline in PaO2/FiO2 was observed at each time-point.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Pulmonary Function : Change From Baseline in Tidal Volume
時間枠：Day 1 up to Day 7

Change from Baseline in tidal volume was observed at each time-point.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Change From Baseline in Arterial Blood Gas (Lactate)
時間枠：Day 1 up to Day 7

Change from Baseline in arterial blood gas (lactate) was observed at each time-point.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7
Days Alive and Free of Any Organ Dysfunction at Day 7
時間枠：At Day 7

Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7).

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 7
Percentage of Patients Alive and Free of All Vasopressors
時間枠：At Day 7, Day 14 and Day 28

Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 7, Day 14 and Day 28
Percentage of Days Alive and Free of Dialysis
時間枠：At Day 7, Day 14 and Day 28

Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 7, Day 14 and Day 28
Percentage of Days Alive and Free of Ventilation
時間枠：At Day 7

Percentage of days alive and free of ventilation was assessed on Days 7, 14, and 28.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 7
Mortality
時間枠：At Day 1, 7, 14, and 28

Mortality was assessed as percentage of patients dead at pre-specified time points.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
At Day 1, 7, 14, and 28
Incidence of Abnormal Changes in ECG
時間枠：Day 1 up to Day 7

The number of patients having abnormal changes in ECG variables during the trial period was presented.

The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Day 1 up to Day 7

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

Ferring Pharmaceuticals

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。

一般刊行物

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11月1日

一次修了 (実際)

2011年8月1日

研究の完了 (実際)

2011年9月1日

試験登録日

最初に提出

2009年9月30日

QC基準を満たした最初の提出物

2009年10月22日

最初の投稿 (見積もり)

2009年10月23日

学習記録の更新

投稿された最後の更新 (実際)

2017年9月25日

QC基準を満たした最後の更新が送信されました

2017年8月24日

最終確認日

2017年8月1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

  • FE 202158 CS02
  • EudraCT: 2009-010798-19

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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