Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease

Sponsor
Efferon JSC
Study ID
NCT07383597
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Efferon LPS — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Feb 3, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Sep 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Baseline therapy
    These patients will receive standard therapy for Crohn disease or ulcerative colitis
  • Experimental: Baseline therapy + Efferon LPS
    These patients will receive standard therapy for Crohn disease or ulcerative colitis and Efferon LPS hemoadsorption.

Primary Outcome Measure

Change in the Crohn's Disease Activity Index (CDAI) score [ Time Frame: 1-90 days ]

Central Contacts

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