Open uncontrolled investigation to evaluate the efficacy and safety of the granulocytes/ monocytes apheresis with the Adacolumn for the treatment of severe alcoholic hepatitis

Open uncontrolled investigation to evaluate the efficacy and safety of the granulocytes/ monocytes apheresis with the Adacolumn for the treatment of severe alcoholic hepatitis - Study for the treatment of severe alcoholic hepatitis with granulocytes/ monocytes apheresis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008642

Enrollment

Registered

2012-08-20

Start date

2010-10-20

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 alcoholic hepatitis

Interventions

SAH patients receive GMA with Adacolumn, at 2 sessions per week for 2 weeks and more until WBC improves. Laboratory examinations (WBC, PT, TB, etc.) and serum cytokines (IL-8, TNF-a, IL-6, ICAM-1) ar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: This study includes patients -with SAH diagnosed according to Japanese SAH diagnostic criteria -with elevated neutrophil count (WBC>= 10000/mcL) -with adequate peripheral blood access -hospitalized, -and obtained written informed consent from all patients or their family.

Exclusion criteria

Exclusion criteria: Patients with granulocyte <=2000/mcL. Patients with severe infection. Patients with severe heart disease. Patients with hypotension (systolic pressure <=80mmHg). Patients with pregnancy or planning to become pregnant. Patients with malignant disease. Patients with severe cirrhosis. Patients with impossible to be quiet during GMA session even with the use of sedatives.

Design outcomes

Primary

Measure	Time frame
Survival rate at 90-days	—

Secondary

Measure	Time frame
The improvement rate of laboratory tests such as WBC, serum total bilirubin or prothrombin time, radiographic exam and pro-inflammatory cytokines/ chemokines. The safety will be also assessed.	—

Countries

Japan

Contacts

Public ContactYoshiyuki Yamagishi

Keio UniversityKeio University School of Medicine, Division of Gastroenterology & Hepatology, Department of Internal Medicine

yyama@a8.keio.jp03-3353-1211

Outcome results

None listed

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