Efficacy and safety of the GCH-01 for severe sepsis and septic shock

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1080221013

Enrollment

Registered

2010-02-23

Start date

2010-02-23

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

severe sepsis and septic shock

Interventions

investigational material(s) Generic name etc : GCH-01 INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : continuous hemod

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) sepsis (2) blood lactate concentration>36mg/dL (4.0mmol/L)

Exclusion criteria

Exclusion criteria: (1) unidentified patients (2) pregnant women, nursing mother, patients may be or in doubt of pregnancy (3) patients are expected to die within 3 days from enrollment (4) patients with the anamnesis of the anaphylactoid reactions which are attributable to previous hemodialyzer/ hemofilter use (5) patients who have not passed 24 hours following an episode of uncontrollable bleeding

Design outcomes

Primary

Measure	Time frame
28 days survival rate after initiation	—

Secondary

Measure	Time frame
(1) serum BUN, Cre (2) accumulated UF volume	—

Outcome results

None listed

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