Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease
NCT07383597 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-02-11
Summary
The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in patients with ulcerative colitis and Crohn disease.
Participants will be assigned to two groups for comparison: a control group receiving baseline therapy and a treatment group receiving baseline therapy in combination with Efferon® LPS hemoadsorption.
Conditions
- Crohn Disease
- Ulcerative Colitis
- Inflammatory Bowel Diseases
Interventions
- DEVICE
-
Efferon LPS
Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Hemoadsorption was administered in 3-4 sessions of at least 2 hours each via peripheral vascular access, with intervals of no more than 5 days between sessions.
Sponsors & Collaborators
-
Efferon JSC
lead INDUSTRY
Principal Investigators
-
Igor Bakulin, PhD, MD · North-Western State Medical University named after I.I.Mechnikov
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-01
- Primary Completion
- 2027-09-01
- Completion
- 2028-03-01
Countries
- Russia
Study Locations
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