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Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction (SCIENS)

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ClinicalTrials.gov Identifier: NCT02246595
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
InflaRx GmbH

Brief Summary:
The trial enrolls patients with early severe sepsis or septic shock displaying at least one newly developed organ dysfunction and showing clinical evidence of pulmonary or abdominal infection. The primary goal of the trial is to assess the pharmacokinetics and pharmacodynamics of the new monoclonal antibody CaCP29 and to characterize safety and tolerability as well as evaluate parameters of efficacy.

Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Biological: CaCP29 Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Placebo-controlled, Double-blind, Dose Controlled Trial in Patients Suffering From Early, Newly Developing Abdominal or Pulmonary Derived Septic Organ Dysfunction to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and to Estimate Efficacy of the New Humanized Monoclonal i.v. Administered Antibody CaCP29
Study Start Date : April 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
Active Comparator: CaCP29
dose escalating i.v. administration of CaCP29 (verum)
Biological: CaCP29
Other Name: IFX-1

Placebo Comparator: Placebo
dose escalation mimicing i.v. placebo treatment:
Biological: Placebo



Primary Outcome Measures :
  1. Plasma Concentration of CaCP29 [ Time Frame: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28 ]

    Pharmacokinetic measures include

    • Plasma concentration over time
    • Maximum observed concentration per infusion
    • Concentration measured immediately before next dosing
    • Area under the curve of plasma concentration per infusion
    • Mean concentration per infusion
    • Terminal phase half-life

  2. Assess the pharmacodynamic (PD) effects of CaCP29 on the change from baseline in plasma concentrations of C5a [ Time Frame: 0h, 2h, 6h, 12h, 14h (only cohort 1), 24h, 26h (only cohort 2 and 3), 48h, 72h, 74h (only cohort 3), days 5, 8, 13, 28 ]
  3. Safety variables will be summarized using descriptive statistics based on adverse event collection [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Anti-drug antibodies (ADA) [ Time Frame: 28 days or hospital discharge ]

    The development of ADA will be described by:

    • Number of patients with detection of anti-drug antibody (ADA)
    • Number of patients with detection of ADA at each time point measured

  2. All-cause mortality rate [ Time Frame: 28 days ]
  3. Morbidity [ Time Frame: daily ]
    • Mean SOFA until Day 10
    • Modified mean SOFA until day 10 (calculated by omitting the Central Nervous System sub-score and calculating the renal subscore without taking urine output into consideration)
    • Mean SOFA Sub-scores until Day 10
    • Days on ICU until Day 28
    • Number of patients ventilated until Day 14
    • Ventilator-free days until Day 14
    • Numbers of patients with renal replacement therapy (RRT) until Day 14
    • RRT-free days until Day 14
    • Numbers of patients with administration of vasopressor until Day 14
    • Vasopressor-free days until Day 14
    • Days without antimicrobial therapy (AMT) until Day 14

  4. Fluid balance [ Time Frame: 28 days or ICU discharge ]
    • Mean daily total fluid intake until Day 28 (maximal until ICU discharge)
    • Mean daily total fluid output until Day 28 (maximal until ICU discharge)
    • Mean daily fluid balance until Day 28 (maximal until ICU discharge)

  5. Change in routine laboratory parameters as compared to baseline [ Time Frame: Days 1, 2, 3, 4, 5, 8, 13, 28 ]
  6. Change in ECG as compared to baseline [ Time Frame: Days 2, 4, 8, 28 ]
  7. Change in vital signs as compared to baseline [ Time Frame: Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Day 28 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria at screening:

  1. Male or female patients >= 18 years old
  2. Written informed consent
  3. Occurrence of at least two criteria of a systemic inflammatory response syndrome (SIRS) not explained by other reasons. These criteria should be present within 12 hours prior to screening
  4. Suspected or confirmed abdominal or pulmonary infection at screening
  5. Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection
  6. At least one of the following acute organ dysfunctions due to sepsis. Each organ dysfunction must have occurred within 12 hours prior to screening, cannot mainly be explained by other disease processes than sepsis and is judged by the investigator as being caused or directly related to an abdominal or pulmonary infectious focus:

    1. respiratory
    2. renal
    3. hematologic
    4. metabolic
    5. cardiovascular (occurred within the last three hours)
  7. Reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process

Key Exclusion Criteria at screening:

  1. Sepsis of other primary cause than pulmonary or abdominal source
  2. Weight > 130 kg at screening
  3. Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
  4. Patients receiving the following concomitant medication within 14 days prior to screening:

    1. Calcineurin inhibitors (e.g., ciclosporine, tacrolimus)
    2. Proliferation inhibitors (e.g., everolimus, sirolimus)
    3. Anti-metabolites (e.g., mycophenolate, mycophenolic acid, azathioprine)
    4. High dose corticosteroids (e.g., > 50mg prednisolon per day or equivalent)
  5. Patients receiving high dose immunoglobulins within 3 months prior to screening
  6. Patients with following abnormal laboratory result: Neutrocytopenia with neutrophil count < 1,000/mm3 unless likely due to sepsis
  7. General criteria:

    1. Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
    2. Women with childbearing potential (defined as within two years of their last menstruation) not willing to practice appropriate contraceptive measures (e.g., implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy, abstinence) while participating in the trial
    3. Participation in any interventional clinical trial within the last three months
    4. Prior participation in this clinical trial
    5. Patient is chronically bed-bound prior to the onset of sepsis
    6. Known intravenous drug abuse
    7. Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
    8. No commitment to full aggressive life support (e.g., do not resuscitate order)

Inclusion Criteria at randomisation:

  1. At least one of the sepsis related organ dysfunction detected at screening is still present
  2. Current treatment with broad spectrum i.v. antibiotics has been started or is ongoing

Exclusion Criteria at randomisation:

  1. Time frame between detection of a non cardiovascular organ dysfunction and start of randomization procedure is more than 15 hours
  2. Time frame between detection of a cardiovascular organ dysfunction and start of randomization is more than six hours
  3. Organ dysfunctions are unlikely to be persistent for next three hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246595


Locations
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Germany
Study Site
Aachen, Germany
Study Site
Augsburg, Germany
Study Site
Bad Saarow, Germany
Study Site
Berlin, Germany
Study Site
Greifswald, Germany
Study Site
Göttingen, Germany
Study Site
Hamburg, Germany
Study Site
Jena, Germany
Study Site
Kiel, Germany
Study Site
Leipzig, Germany
Study Site
Oldenburg, Germany
Sponsors and Collaborators
InflaRx GmbH
Investigators
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Principal Investigator: Michael Bauer, Prof. Dr. University Hospital Jena

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Responsible Party: InflaRx GmbH
ClinicalTrials.gov Identifier: NCT02246595     History of Changes
Other Study ID Numbers: IFX-1-P2.1
2013-001037-40 ( EudraCT Number )
First Posted: September 23, 2014    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016
Keywords provided by InflaRx GmbH:
Sepsis
Severe Sepsis
Septic Shock
Systemic Inflammatory Response Syndrome
Organ Dysfunction
Additional relevant MeSH terms:
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Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Cisplatin
Antineoplastic Agents