Hepatitis E Virus Infection in Hematopoietic Stem Cell Transplantation Recipients : A single center prospective trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

TCTR

Registry ID

TCTR20260608005

Enrollment

Registered

2026-06-08

Start date

2026-06-18

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Hepatitis E virus (HEV) infection in hematopoietic stem cell transplantation (HSCT) recipients Hepatitis E virus (HEV) Hematopoietic stem cell transplantation (HSCT) Chronic hepatitis E

Interventions

Prospective screening for hepatitis E virus infection using anti HEV IgG at baseline and HEV RNA plus anti HEV IgM testing at Days 30 and 90 after hematopoietic stem cell transplantation. No therapeut

Screening

Hepatitis E virus screening

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age 18 years or more. 2.Undergoing autologous or allogeneic hematopoietic stem cell transplantation (HSCT) during the study period 3.Able and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.History of solid organ transplantation 2.Known active chronic liver disease before HSCT with evidence of active disease including chronic hepatitis B with detectable HBV DNA, hepatitis C with detectable HCV RNA, active autoimmune hepatitis, active primary biliary cholangitis, active primary sclerosing cholangitis, or decompensated cirrhosis 3.Known active cytomegalovirus CMV, Epstein Barr virus EBV, adenovirus, or herpes simplex virus HSV hepatitis at enrollment 4.Sinusoidal obstruction syndrome or veno occlusive disease diagnosed before or at enrollment 5.Receipt of intravenous immunoglobulin IVIG within 3 months before enrollment 6. Inability or unwillingness to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Baseline anti HEV IgG seroprevalence Before HSCT Proportion of participants with positive anti HEV IgG at baseline,Incidence of HEV infection Within 90 days after HSCT Proportion of participants with HEV RNA positivity and or anti HEV IgM positivity	—

Secondary

Measure	Time frame
Chronic HEV infection Day 90 Proportion of participants with persistent HEV RNA positivity for at least 3 months,Anti HEV IgG loss Day 90 Proportion of baseline anti HEV IgG positive participants who become anti HEV IgG negative,HEV related mortality Within 90 days after HSCT Number and proportion of deaths attributable to HEV infection,Risk factors for HEV infection Baseline to Day 90 after HSCT Association between demographic clinical and transplant related factors and HEV RNA positivity using logistic regression	—

Measure

Time frame

Chronic HEV infection Day 90 Proportion of participants with persistent HEV RNA positivity for at least 3 months,Anti HEV IgG loss Day 90 Proportion of baseline anti HEV IgG positive participants who become anti HEV IgG negative,HEV related mortality Within 90 days after HSCT Number and proportion of deaths attributable to HEV infection,Risk factors for HEV infection Baseline to Day 90 after HSCT Association between demographic clinical and transplant related factors and HEV RNA positivity using logistic regression

—

Countries

Thailand

Contacts

Public ContactPeampost Sinsakolwat

Faculty of Medicine, Chiang Mai University

peampost.s@cmu.ac.th0838679395

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026