A phase 1/2 study of ONO-4538

Phase 1

• Conditions: Sepsis or septick shock

• Registration Number: JPRN-jRCT2080223545
• Lead Sponsor: ONO PHARMACEUTICAL CO.,LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Documented or suspected infection
2. Severe sepsis or septic shock for at least 24 hours
3. Sepsis-induced immunosuppression
4. In Intensive Care Unit (ICU) with no plans to discharge in next 24 hours

Exclusion Criteria

1. Previous episode of severe sepsis or septic shock with ICU admission during the current hospitalization
2. Autoimmune disease
3. Organ or bone marrow transplant
4. Known history of malignancy and has an anticipated survival of < 3 months
5. Human immunodeficiency virus (HIV) infection and not on therapy prior to this episode of sepsis; hepatitis C virus(HCV) infection; Chronic hepatitis B virus (HBV) infection and not on treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified