A phase 1/2 study of ONO-4538

Phase 1/2 Study of ONO-4538 in Japanese Participants with Sepsis or Septic Shock

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223545

Enrollment

Registered

2017-05-30

Start date

2017-05-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis or septick shock

Interventions

investigational material(s) Generic name etc : ONO-4538 INN of investigational material : nivolumab Therapeutic category code : 419 Other agents activating cellular function Dosage and Administration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Phamacokinetics, Safety, Tolerability, Pharmacodynamics	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026