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

NCT01612676 | Completed Phase 2 Results DMC

• 2 other identifiers: 0000252012-001254-26
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Day 1 up to Day 28

Secondary Outcomes (7)

• Urinary Output

  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

  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

  Day 1 up to Day 2

• Morbidity Assessment

  Day 1 up to Day 28

• Graded Morbidity

  Day 1 up to Day 28

Study Arms (1)

Drug

EXPERIMENTAL

FE 202158

Drug: FE 202158

Interventions

FE 202158 DRUG

Drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (4)

Erasme Hospital Free University of Brussels

Brussels, Belgium

Location

Saint-Luc University Hospital

Brussels, Belgium

Location

University Hospital Brussels

Brussels, Belgium

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

vasopressin, Phe(2)-Ile(3)-Hgn(4)-Orn(iPr)(8)-

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Limitations and Caveats

There were no limitations or caveats in this trial

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: June 6, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 23, 2017
• Results First Posted: January 16, 2017

Record last verified: 2017-02

Locations

DK (1); BE (3)