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An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation

An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation - An open-label study of the effects of intraoperative double filtration plasmapheresis and adoptive immunotherapy with liver allograft derived lymphocytes combination therapy for hepatitis C recurrence after living donor liver transplantation

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008754
Enrollment
6
Registered
2012-08-23
Start date
2012-04-01
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

chronic hepatitis C

Interventions

1)DFPP therapy Transplant recipients receive DFPP therapy 3 days before and during living donor liver transplantation (for 4 hours and 10 hours, respectively) to remove hepatitis C virus. 2)Adoptive

Sponsors

Hiroshima University Hospital, Department of surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The subjects must be satisfactory the following conditions. 1)Patients must consent to adoptive immunotherapy with liver allograft derived lymphocytes 2)Patients must have HCV liver cirrhosis for which liver transplantation is best indicated. 3)Patients must be equal to or more than 20 years old. 4)Written informed consent must be obtained from patients.

Exclusion criteria

Exclusion criteria: The following patients must be excluded. 1)Recipients with fluminant hepatitis 2)ABO blood type incompatible recipients 3)Recipients of re-transplantation 4)Recipients of deceased donor liver transplantation 5)Patients with the past history of severe shock reactions to any therapy using extracorporeal circulation. 6)Patients who have un-controlable heart disease 7)Patients who are participated in other clinical study within 3 months. 8)Patients who are during pregnancy, lactation expectant, and desiring future fertility. 9)Patients who are judged inappropriate for the clinical trial by doctors. 10)Patients with the past history of severe allergic reactions to nafamostat mesilate.

Design outcomes

Primary

MeasureTime frame
Evaluation of antivirus activity (recurrence rate of HCV RNA) of DFPP and adoptive immunotherapy combination therapy

Secondary

MeasureTime frame
1.Evaluation of virus reduction effect by DFPP and adoptive immunotherapy combination therapy 2.Adverse effects of DFPP and adoptive immunotherapy combination therapy

Countries

Japan

Contacts

Public ContactTakashi Onoe

Hiroshima University Hiroshima University Hospital, Department of surgery

tonoemd@gmail.com082-257-5222

Outcome results

None listed

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