- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246595
Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction (SCIENS)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Aachen, Germany
- Study Site
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Augsburg, Germany
- Study Site
-
Bad Saarow, Germany
- Study Site
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Berlin, Germany
- Study Site
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Greifswald, Germany
- Study Site
-
Göttingen, Germany
- Study Site
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Hamburg, Germany
- Study Site
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Jena, Germany
- Study Site
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Kiel, Germany
- Study Site
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Leipzig, Germany
- Study Site
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Oldenburg, Germany
- Study Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria at screening:
- Male or female patients >= 18 years old
- Written informed consent
- 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
- Suspected or confirmed abdominal or pulmonary infection at screening
- Broad spectrum i.v. antimicrobial therapy to treat abdominal or pulmonary infection
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:
- respiratory
- renal
- hematologic
- metabolic
- cardiovascular (occurred within the last three hours)
- Reasonable likelihood that administration of study drug can be started within 3.5 hours after start of screening process
Key Exclusion Criteria at screening:
- Sepsis of other primary cause than pulmonary or abdominal source
- Weight > 130 kg at screening
- Any other disease and condition that is likely to interfere with evaluation of study product, outcome assessment or satisfactory conduct of the study
Patients receiving the following concomitant medication within 14 days prior to screening:
- Calcineurin inhibitors (e.g., ciclosporine, tacrolimus)
- Proliferation inhibitors (e.g., everolimus, sirolimus)
- Anti-metabolites (e.g., mycophenolate, mycophenolic acid, azathioprine)
- High dose corticosteroids (e.g., > 50mg prednisolon per day or equivalent)
- Patients receiving high dose immunoglobulins within 3 months prior to screening
- Patients with following abnormal laboratory result: Neutrocytopenia with neutrophil count < 1,000/mm3 unless likely due to sepsis
General criteria:
- Pregnant (in women of childbearing potential an urine pregnancy test has to be performed) or breast-feeding women
- 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
- Participation in any interventional clinical trial within the last three months
- Prior participation in this clinical trial
- Patient is chronically bed-bound prior to the onset of sepsis
- Known intravenous drug abuse
- 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
- No commitment to full aggressive life support (e.g., do not resuscitate order)
Inclusion Criteria at randomisation:
- At least one of the sepsis related organ dysfunction detected at screening is still present
- Current treatment with broad spectrum i.v. antibiotics has been started or is ongoing
Exclusion Criteria at randomisation:
- Time frame between detection of a non cardiovascular organ dysfunction and start of randomization procedure is more than 15 hours
- Time frame between detection of a cardiovascular organ dysfunction and start of randomization is more than six hours
- Organ dysfunctions are unlikely to be persistent for next three hours
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CaCP29
dose escalating i.v.
administration of CaCP29 (verum)
|
Other Names:
|
Placebo Comparator: Placebo
dose escalation mimicing i.v.
placebo treatment:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
|
Safety variables will be summarized using descriptive statistics based on adverse event collection
Time Frame: 28 days
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28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-drug antibodies (ADA)
Time Frame: 28 days or hospital discharge
|
The development of ADA will be described by:
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28 days or hospital discharge
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All-cause mortality rate
Time Frame: 28 days
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28 days
|
|
Morbidity
Time Frame: daily
|
|
daily
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Fluid balance
Time Frame: 28 days or ICU discharge
|
|
28 days or ICU discharge
|
Change in routine laboratory parameters as compared to baseline
Time Frame: Days 1, 2, 3, 4, 5, 8, 13, 28
|
Days 1, 2, 3, 4, 5, 8, 13, 28
|
|
Change in ECG as compared to baseline
Time Frame: Days 2, 4, 8, 28
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Days 2, 4, 8, 28
|
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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
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Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Day 28
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael Bauer, Prof. Dr., University Hospital Jena
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IFX-1-P2.1
- 2013-001037-40 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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