Phase 2
N=27
A Study of IL-7 to Restore Absolute Lymphocyte Counts in Sepsis Patients
Severe Sepsis With Septic Shock
Bottom Line
View on ClinicalTrials.gov: NCT02640807 ↗Enrolled (actual)
27
Serious AEs
59.3%
Results posted
Jul 2020
Primary outcome: Primary: Immune Reconstitution of Lymphocytopenic Sepsis Patients — 8; 7; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Interleukin-7 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Revimmune
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immune Reconstitution of Lymphocytopenic Sepsis Patients |
8; 7; 8 | — |
| SECONDARY CYT107 Effect on Absolute Lymphocyte Count |
6; 6; 4 | — |
| SECONDARY CYT107 Immunogenicity |
0; 0; 0 | — |
Summary
A multicenter, randomized, double-blinded, placebo-controlled study of two dosing frequencies of recombinant Interleukin-7 (CYT107) treatment to restore absolute lymphocyte counts in sepsis patients; IRIS-7B (Immune Reconstitution of Immunosuppressed Sepsis patients).
A parallel study will be performed in France to allow a common statistical analysis of the primary end points and analysis for the enrolled patient population.
Eligibility Criteria
Inclusion Criteria
- Patients of age ≥ 18 yrs and older but 3-5 days as defined by an APACHE II score of ≥ 35 at time of consideration for study eligibility
- Patients with a history of or who currently have evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosis, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.
- Patients who have received solid organ transplant or bone marrow transplant
- Patients with active or a history of acute or chronic lymphocytic leukemia
- AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
- History of splenectomy
- Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia
- Pregnant or lactating women
- Participation in another investigational interventional study within the last 6 months prior to study entry, with the exception of studies aimed at testing sedation products belonging to standard of care such as Propofol, Dexmedetomidine, Midazolam.
- Patients receiving immunosuppressive drugs, e.g., TNF-alpha inhibitors, for rheumatoid arthritis, inflammatory bowel disease or any other reason, or systemic corticosteroids other than hydrocortisone at a dose of 300 mg/day
- Patients receiving concurrent immunotherapy or biologic agents including: growth factors, cytokines and interleukins, (other than the study medication); for example IL-2,growth factors, interferons, HIV vaccines, immunosuppressive drugs, hydroxyurea, immunoglobulins, adoptive cell therapy
- Prisoners
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Data sourced from ClinicalTrials.gov (NCT02640807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.