CompletedPhase 2

A Phase 2 Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

Belgium, France148 participantsStarted 2020-11-30

Plain-language summary

A Phase 2, Multi-Center, Randomized, Placebo-Controlled, Dose-Finding Study Evaluating Efficacy, Safety and Tolerability of Different Doses and Regimens of Allocetra-OTS for the Treatment of Organ Failure in Adult Sepsis Patients

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. Male or female ≥18 years and ≤90 years of age.
✓. Meets Sepsis 3 criteria with a SOFA score ≥5 above pre-admission status
✓. Sepsis due to infection in at least one of the below organs:
✓.1. Community-Acquired Pneumonia (CAP). 3.2. Urinary tract infection 3.3. Acute cholecystitis diagnosed by Tokyo criteria 3.4. Acute cholangitis diagnosed by Tokyo criteria 3.5. Other intra-abdominal infections (IAI) 3.6. Skin or soft tissue infection
✓. Adequate source control

Exclusion criteria

✕. Sepsis due to infection other than lung infection, UTI, IAI, skin/soft tissue infection or sepsis patients where site of infection is unclear or unknown.
✕. On chronic dialysis.
✕. Patients with acute pancreatitis
✕. Moribund patients
✕. Weight \<50 kg or \>120 kg or BMI \>40 kg/m\^2.
✕. SOFA score ≥14 at screening.
✕. Patients with nosocomial infection.
✕. A known malignancy.

What they're measuring

Efficacy: Change from baseline in SOFA score

Timeframe: 28 days

Safety: Number and severity of AEs and SAEs

Timeframe: 28 days

Trial details

NCT IDNCT04612413

SponsorEnlivex Therapeutics Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-12

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