Studying Complement Inhibition in Early, Newly Developing Septic Organ Dysfunction

Phase 2

Completed

• Conditions: Septic Shock; Severe Sepsis
• Interventions: Biological: CaCP29; Biological: Placebo

• Registration Number: NCT02246595
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-22
• Study First Posted: 2014-09-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-22
• Last Update Posted: 2016-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CaCP29	CaCP29	dose escalating i.v. administration of CaCP29 (verum)
Placebo	Placebo	dose escalation mimicing i.v. placebo treatment:

Primary Outcome Measures

Name	Time	Method
Safety variables will be summarized using descriptive statistics based on adverse event collection	28 days
Plasma Concentration of CaCP29	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
Assess the pharmacodynamic (PD) effects of CaCP29 on the change from baseline in plasma concentrations of C5a	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

Secondary Outcome Measures

Name	Time	Method
Change in routine laboratory parameters as compared to baseline	Days 1, 2, 3, 4, 5, 8, 13, 28
Change in vital signs as compared to baseline	Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, Day 28
Anti-drug antibodies (ADA)	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
All-cause mortality rate	28 days
Change in ECG as compared to baseline	Days 2, 4, 8, 28
Morbidity	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
Fluid balance	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)

Trial Locations

Locations (1)

Study Site; 🇩🇪 Oldenburg, Germany