multi-center trial of the efficacy and safety of G-1 in patients with sepsis or septic shock

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080225183

Enrollment

Registered

2020-04-30

Start date

2020-10-01

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(including sheptic shock)

Interventions

investigational material(s) Generic name etc : G-1 INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : blood purification

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.sepsis and Septic shock (based on J-SSCG 2016) 2.APACHE II score 17-34 3.informed consent was obtained from the patient or the legal representative

Exclusion criteria

Exclusion criteria: 1.patients who are expected to die within 3 days 2.patients who have not undergone surgical treatment for resectable infected lesions 3.patients who have not passed a year following an organ transplant 4.patients who are expected uncontrollable bleeding by using G-1 5.unidentified patients 6.pregnant, or nursing women

Design outcomes

Primary

Measure	Time frame
efficacy delta SOFA score safety 28 day mortality	—

Secondary

Measure	Time frame
efficacy 6 organ SOFA score, Blood cytokine etc safety Adverse event clinical examination device failure	—

Countries

Japan

Outcome results

None listed

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