Septic ShockPhase 2NCT01612676

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

A Phase 2 study testing FE 202158 in people with Septic Shock, run by Ferring Pharmaceuticals at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Septic Shock
What is being tested?: FE 202158
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 4 sitesin 2 countries
Study dates: Jun 2012to Nov 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 19Show fewer

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

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Belgium3 sites

Erasme Hospital Free University of Brussels
Brussels
Saint-Luc University Hospital
Brussels
University Hospital Brussels
Brussels

Other trials in Belgium

Denmark1 site

Hvidovre Hospital
Hvidovre

Other trials in Denmark

About this study

Official title: An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.

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.

Conditions: Septic Shock
Being tested: FE 202158
Medical subject headings: Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FE 202158Drug

Study groups in NCT01612676
Study group	Role	What they receive
Drug	Experimental	FE 202158 Receives: Drug: FE 202158

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine
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.
Measured: 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
Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.
Measured: 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
Infusion rate of FE 202158 was presented from Day 1 up to Day 7.
Measured: 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 Norepinephrine
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.
Measured: 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 Norepinephrine
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.
Measured: 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.
Time to Septic Shock Resolution
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.
Measured: Day 1 up to Day 28

Secondary outcomes (7)

Urinary Output
The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.
Measured: 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
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.
Measured: 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.
Summary of Investigator Reported Outcomes
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.
Measured: Day 1 up to Day 2
Morbidity Assessment
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.
Measured: Day 1 up to Day 28
Graded Morbidity
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.
Measured: Day 1 up to Day 28
Mortality
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.
Measured: Day 1 up to Day 28
Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram
Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).
Measured: Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Nov 2013

First posted6 Jun 2012 (estimated)
Study startJun 2012
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Septic ShockStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01612676
Sponsor's protocol ID: 000025
Other IDs: 2012-001254-26
Status last verified: Feb 2017
First submitted: 11 May 2012
Last updated: 23 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Septic Shock trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.
ClinicalTrials.gov ID: NCT01612676
Acronym / sponsor ID: 000025
Conditions: Septic Shock
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jun 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 6 Jun 2012 (estimated)
Results: Posted 16 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Drug	Experimental	Drug: FE 202158FE 202158

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FE 202158	Drug	Drug

Primary outcome

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.
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.
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.
Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.
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.
Infusion rate of FE 202158 was presented from Day 1 up to Day 7.
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.
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.
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.
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.
Time to Septic Shock Resolution
Time frame: Day 1 up to Day 28
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.

7 secondary outcomes

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.
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.
Summary of Investigator Reported Outcomes
Time frame: Day 1 up to Day 2
Morbidity Assessment
Time frame: Day 1 up to Day 28
Graded Morbidity
Time frame: Day 1 up to Day 28
Mortality
Time frame: Day 1 up to Day 28
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

Results and safety

Results posted to the registry on 16 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infusion Regimen 1: 3.75 ng/kg/Min	6	4
Infusion Regimen 2: 5.0 ng/kg/Min	7	3
Infusion Regimen 3: 7.5 ng/kg/Min	5	4
Infusion Regimen 4: Modified 3.75 ng/kg/Min	13	10

Primary outcome: 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.. Number (60% Confidence Interval). Unit: Percentage of patients

Measure	Infusion Regimen 1: 3.75 ng/kg/Min n = 5	Infusion Regimen 2: 5.0 ng/kg/Min n = 7	Infusion Regimen 3: 7.5 ng/kg/Min n = 5	Infusion Regimen 4: Modified 3.75 ng/kg/Min n = 13
Day 1 (Post 1 h)	20.0 (4.4 to 49.0)	42.9 (22.8 to 65.0)	60.0 (32.7 to 83.1)	7.7 (1.7 to 21.3)
Day 1 (Post 3 h)	20.0 (4.4 to 49.0)	14.3 (3.1 to 37.1)	60.0 (32.7 to 83.1)	53.8 (38.7 to 68.4)
Day 1 (Post 6 h)	25.0 (5.4 to 58.2)	14.3 (3.1 to 37.1)	80.0 (51.0 to 95.6)	76.9 (61.6 to 88.0)
Day 1 (Post 12 h)	60.0 (32.7 to 83.1)	28.6 (12.0 to 51.7)	80.0 (51.0 to 95.6)	53.8 (38.7 to 68.4)
Day 1 (Post 18 h)	60.0 (32.7 to 83.1)	42.9 (22.8 to 65.0)	80.0 (51.0 to 95.6)	66.7 (50.3 to 80.2)
Day 1 (Post 24 h)	80.0 (51.0 to 95.6)	42.9 (22.8 to 65.0)	80.0 (51.0 to 95.6)	61.5 (46.1 to 75.2)
Day 2 (Post 36 h)	80.0 (51.0 to 95.6)	66.7 (41.5 to 86.0)	80.0 (51.0 to 95.6)	61.5 (46.1 to 75.2)
Day 2 (Post 48 h)	80.0 (51.0 to 95.6)	50.0 (26.9 to 73.1)	80.0 (51.0 to 95.6)	76.9 (61.6 to 88.0)

Population analysed: Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.

Primary outcome: Cumulative Dose of FE 202158

Measure	Infusion Regimen 1: 3.75 ng/kg/Min n = 5	Infusion Regimen 2: 5.0 ng/kg/Min n = 7	Infusion Regimen 3: 7.5 ng/kg/Min n = 5	Infusion Regimen 4: Modified 3.75 ng/kg/Min n = 13
Day 1 (Post 12 h)	2451 (2226.3 to 2675.8)	3276.3 (2941.3 to 3611.3)	2946 (2426.2 to 3465.8)	2377 (2220.2 to 2533.7)
Day 1 (Post 24 h)	4217.4 (3736.5 to 4698.3)	5502.2 (4698.7 to 6305.7)	4927.3 (4064.8 to 5789.8)	3818.8 (3429.6 to 4208.0)
Day 2 (Post 36 h)	4463.9 (3877.0 to 5050.7)	7535.9 (6206.2 to 8865.7)	5842 (4554.6 to 7129.4)	4619.2 (4005.0 to 5233.4)
Day 2 (Post 48 h)	4523.9 (3900.8 to 5146.9)	9185 (7405.2 to 10963.9)	6716 (4674.3 to 8757.6)	5225 (4401.7 to 6048.3)
Day 3 (Post 72 h)	4523.9 (3900.8 to 5146.9)	11511.4 (9096.1 to 13926.7)	7902 (4758.8 to 11045.1)	5860.1 (4763.9 to 6956.4)
Day 4 (Post 96 h)	4523.9 (3900.8 to 5146.9)	12204.6 (9365.7 to 15043.4)	7999.8 (4765.3 to 11234.3)	6298.6 (4939.5 to 7657.7)
Day 5 (Post 120 h)	4523.9 (3900.8 to 5146.9)	12865.3 (9561.7 to 16168.9)	7999.8 (4765.3 to 11234.3)	6621.8 (5033.5 to 8210.1)
Day 6 (Post 144 h)	4523.9 (3900.8 to 5146.9)	13543.7 (9724.0 to 17363.3)	7999.8 (4765.3 to 11234.3)	6696.5 (5052.9 to 8340.1)

Population analysed: Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.

Primary outcome: Infusion Rate of FE 202158

Measure	Infusion Regimen 1: 3.75 ng/kg/Min n = 5	Infusion Regimen 2: 5.0 ng/kg/Min n = 7	Infusion Regimen 3: 7.5 ng/kg/Min n = 5	Infusion Regimen 4: Modified 3.75 ng/kg/Min n = 13
Day 1 (Post 12 h)	3.25 (1.29)	4.13 (2.09)	3.08 (2.56)	2.43 (1.41)
Day 1 (Post 24 h)	0.94 (1.88)	3.39 (2.37)	1.59 (2.19)	1.39 (1.65)
Day 2 (Post 36 h)	0.23 (0.47)	2.66 (2.27)	2.08 (2.77)	1.25 (1.76)
Day 2 (Post 48 h)	0.00 (0.00)	2.51 (2.29)	1.79 (3.57)	0.69 (1.28)
Day 3 (Post 72 h)	0.00 (0.00)	0.82 (2.02)	0.61 (1.22)	0.39 (1.08)
Day 4 (Post 96 h)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.33 (1.08)
Day 5 (Post 120 h)	0.00 (0.00)	0.99 (2.21)	0.00 (0.00)	0.00 (0.00)
Day 6 (Post 144 h)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)

Population analysed: Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed.

Primary outcome: Cumulative Dose of Norepinephrine

Measure	Infusion Regimen 1: 3.75 ng/kg/Min n = 5	Infusion Regimen 2: 5.0 ng/kg/Min n = 7	Infusion Regimen 3: 7.5 ng/kg/Min n = 4	Infusion Regimen 4: Modified 3.75 ng/kg/Min n = 13
Day 1 (Post 12 h)	358.1 (91.8 to 624.3)	172.1 (96.5 to 247.8)	118.0 (12.7 to 223.3)	73.1 (47.2 to 99.0)
Day 1 (Post 24 h)	720.8 (131.8 to 1309.7)	338.0 (171.5 to 504.6)	357.5 (17.8 to 697.2)	149.5 (90.4 to 208.6)
Day 2 (Post 36 h)	720.8 (131.8 to 1309.7)	406.2 (214.7 to 597.6)	778.2 (26.9 to 1529.5)	197.8 (111.4 to 284.2)
Day 2 (Post 48 h)	720.8 (131.8 to 1309.7)	495.5 (296.4 to 694.5)	778.4 (27.2 to 1529.7)	232.8 (120.6 to 345.1)
Day 3 (Post 72 h)	720.8 (131.8 to 1309.7)	669.0 (390.8 to 947.2)	778.4 (27.2 to 1529.7)	279.1 (129.5 to 428.7)
Day 4 (Post 96 h)	720.8 (131.8 to 1309.7)	829.6 (438.1 to 1221.1)	778.4 (27.2 to 1529.7)	303.1 (133.6 to 472.6)
Day 5 (Post 120 h)	720.8 (131.8 to 1309.7)	1039.5 (473.7 to 1605.2)	778.4 (27.2 to 1529.7)	307.8 (134.4 to 481.2)
Day 6 (Post 144 h)	720.8 (131.8 to 1309.7)	1152.0 (489.2 to 1814.7)	778.4 (27.2 to 1529.7)	307.8 (134.4 to 481.2)

Population analysed: Full analysis set (FAS) was the primary dataset of interest. FAS comprised of all patients who were dosed. One patient in the 7.5 ng/kg/min group started the vasopressor support without prior administration of norepinephrine, and MAP was adequately controlled as needed.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from start of study up to the end of trial on Day 28, or end of follow-up period as applicable.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infusion Regimen 1: 3.75 ng/kg/Min	1 of 5 (20%)	4 of 5 (80%)	Not reported
Infusion Regimen 2: 5.0 ng/kg/Min	4 of 7 (57.1%)	7 of 7 (100%)	Not reported
Infusion Regimen 3: 7.5 ng/kg/Min	2 of 5 (40%)	4 of 5 (80%)	Not reported
Infusion Regimen 4: Modified 3.75 ng/kg/Min	3 of 13 (23.1%)	12 of 13 (92.3%)	Not reported
Total	10 of 30 (33.3%)	27 of 30 (90%)	Not reported

Limitations and caveats (from the sponsor): There were no limitations or caveats in this trial

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Development Support study director

Ferring Pharmaceuticals

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FE 202158 in people with Septic Shock, run by Ferring Pharmaceuticals at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Belgium, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01612676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.