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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

NCTNCT01612676 (opens ClinicalTrials.gov in a new tab)Other id000025Other id2012-001254-26
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
31 participants (actual)
Sponsor
Ferring Pharmaceuticals · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

Belgium, Denmark

Start
Jun 2012
Primary completion
Nov 2013
Completion
Nov 2013
First posted
6 Jun 2012 (estimated)
Last update posted
23 Mar 2017
Conditions
Septic Shock

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201220132014
  1. Ph 2

    Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

    NCT01612676

    Jun 2012 to Nov 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this trial is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.

Interventions

  • FE 202158Drug

Arms1

  • Experimental

    Drug

    FE 202158

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine

    Time frame · Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

    Registry description

    Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (\>60 mmHg) without norepinephrine is presented.

  2. Cumulative Dose of FE 202158

    Time frame · Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

    Registry description

    Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.

  3. Infusion Rate of FE 202158

    Time frame · Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

    Registry description

    Infusion rate of FE 202158 was presented from Day 1 up to Day 7.

  4. Cumulative Dose of Norepinephrine

    Time frame · Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

    Registry description

    Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.

  5. Infusion Rate of Norepinephrine

    Time frame · Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

    Registry description

    Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.

  6. Time to Septic Shock Resolution

    Time frame · Day 1 up to Day 28

    Registry description

    The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration. Time to all but one patient out of septic shock is presented.

Secondary outcomes(7)

  1. Urinary Output

    Time frame · Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

    Registry description

    The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.

  2. Fluid Balance

    Time frame · Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

    Registry description

    The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.

  3. Summary of Investigator Reported Outcomes

    Time frame · Day 1 up to Day 2

    Registry description

    Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.

  4. Morbidity Assessment

    Time frame · Day 1 up to Day 28

    Registry description

    Percentage of all the "Days alive and out/free of" intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero.

  5. Graded Morbidity

    Time frame · Day 1 up to Day 28

    Registry description

    Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.

  6. Mortality

    Time frame · Day 1 up to Day 28

    Registry description

    Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.

  7. Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram

    Time frame · Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion

    Registry description

    Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine

GroupValue (Percentage of patients)
Infusion Regimen 1: 3.75 ng/kg/Min20.0
Infusion Regimen 2: 5.0 ng/kg/Min42.9
Infusion Regimen 3: 7.5 ng/kg/Min60.0
Infusion Regimen 4: Modified 3.75 ng/kg/Min7.7
Primary outcomeMean· Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

Cumulative Dose of FE 202158

GroupValue (ng/kg)
Infusion Regimen 1: 3.75 ng/kg/Min2451
Infusion Regimen 2: 5.0 ng/kg/Min3276.3
Infusion Regimen 3: 7.5 ng/kg/Min2946
Infusion Regimen 4: Modified 3.75 ng/kg/Min2377
Primary outcomeMean· Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

Infusion Rate of FE 202158

GroupValue (ng/kg/min)Spread
Infusion Regimen 1: 3.75 ng/kg/Min3.251.29
Infusion Regimen 2: 5.0 ng/kg/Min4.132.09
Infusion Regimen 3: 7.5 ng/kg/Min3.082.56
Infusion Regimen 4: Modified 3.75 ng/kg/Min2.431.41
Secondary and other outcome results(5)
Secondary outcomeMean· Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

Urinary Output

GroupValue (mL/kg)
Infusion Regimen 1: 3.75 ng/kg/Min24.9
Infusion Regimen 2: 5.0 ng/kg/Min21.8
Infusion Regimen 3: 7.5 ng/kg/Min36.0
Infusion Regimen 4: Modified 3.75 ng/kg/Min24.1
Secondary outcomeMean· Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.

Fluid Balance

GroupValue (mL/kg)
Infusion Regimen 1: 3.75 ng/kg/Min50
Infusion Regimen 2: 5.0 ng/kg/Min72
Infusion Regimen 3: 7.5 ng/kg/Min62
Infusion Regimen 4: Modified 3.75 ng/kg/Min61
Secondary outcomeMean· Day 1 up to Day 2

Summary of Investigator Reported Outcomes

GroupValue (Score on scale)Spread
Infusion Regimen 1: 3.75 ng/kg/Min4.43.78
Infusion Regimen 2: 5.0 ng/kg/Min3.572.51
Infusion Regimen 3: 7.5 ng/kg/Min9.01.22
Infusion Regimen 4: Modified 3.75 ng/kg/Min7.852.54
Secondary outcomeNumber· Day 1 up to Day 28

Morbidity Assessment

GroupValue (percentage of days within 28 days)
Infusion Regimen 1: 3.75 ng/kg/Min51.6
Infusion Regimen 2: 5.0 ng/kg/Min31.4
Infusion Regimen 3: 7.5 ng/kg/Min61.2
Infusion Regimen 4: Modified 3.75 ng/kg/Min58.8
Secondary outcomeNumber· Day 1 up to Day 28

Graded Morbidity

GroupValue (patients)
Infusion Regimen 1: 3.75 ng/kg/Min2
Infusion Regimen 2: 5.0 ng/kg/Min0
Infusion Regimen 3: 7.5 ng/kg/Min2
Infusion Regimen 4: Modified 3.75 ng/kg/Min6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Infusion Regimen 1: 3.75 ng/kg/MinFE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.–1 / 54 / 5
Infusion Regimen 2: 5.0 ng/kg/MinFE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.–4 / 77 / 7
Infusion Regimen 3: 7.5 ng/kg/MinFE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.–2 / 54 / 5
Infusion Regimen 4: Modified 3.75 ng/kg/MinFE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.–3 / 1312 / 13
TotalSummation of adverse events in all treatment arms–10 / 3027 / 30

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

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Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Signed informed consent form by the patient or a legal representative according to local regulations' * Man or women 18 years of age or older * Body weight below 115 kg for male patients and 100 kg for female patients * Proven or suspected infection * Septic shock, i.e. vasodilatory hypotension requiring vasopressor support * Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication Exclusion Criteria: * Present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina) * Known or suspected endocarditis * 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 * Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C * Pregnancy or breastfeeding * Any cause of hypotension other than early septic shock * Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion * Proven or suspected acute mesenteric ischemia, as judged by the investigator * Known episode of septic shock within 1 month prior to screening * Death anticipated within 24 hours, or due to the underlying disease within 3 months * Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker * Brain injury within current hospitalisation * Present hospitalisation with burn injury * Symptomatic peripheral vascular disease including Raynaud's syndrome * Previously included in this trial * Intake of an Investigational Medicinal Product (IMP) 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 interventional clinical trial * Considered by the investigator to be unsuitable to participate in the trial for any other reason

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