UMIN ID: UMIN000055500
Registered date:01/10/2024
The Usefulness of iTACT-HBcrAg Monitoring in Detecting HBV Reactivation Among HBV-resolved Patients with Hematological Tumors: a prospective multicenter observational study
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Hematological Tumors where the doctor considers there to be a high risk of HBV reactivation |
| Date of first enrollment | 2024/10/01 |
| Target sample size | 375 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Success rate of iTACT-HBcrAg monitoring |
|---|---|
| Secondary Outcome | 1) HBV reactivation rate 2) Incidence rate of HBV reactivation-related liver damage/hepatitis 3) Specificity of iTACT-HBcrAg 4) Rate of HBs antibody positivity 5) Success rate of iTACT-HBsAg monitoring (ancillary study) 6) Specificity of iTACT-HBsAg (ancillary study) |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) The pre-enrollment HBV-DNA level is 1.3 Log IU/mL or higher (if measured at the enrolling facility within 4 weeks prior to enrollment). 2) The diagnosis of previous HBV reactivation occurred within 12 months prior to enrollment. 3) There is a history of nucleotide analogue administration, and it has been within 6 months since its discontinuation. 4) Nucleotide analogue therapy is being administered at the time of enrollment. 5) It is clearly impossible to plan for a 1.5-year follow-up at the enrolling facility after enrollment. |
Related Information
| Primary Sponsor | Kumamoto University Hospital |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiro Tatetsu |
| Address | 1-1-1 Honjo Chuo ku, Kumamoto, Kumamoto, Japan Japan 860-8556 |
| Telephone | 096-363-5156 |
| tatetsu@kumamoto-u.ac.jp | |
| Affiliation | Kumamoto University Hospital Department of Hematology, Rheumatology and Infectious Diseases |
| scientific contact | |
| Name | Yasuhito Tanaka |
| Address | 1-1-1 Honjo Chuo ku, Kumamoto, Kumamoto, Japan Japan |
| Telephone | 096-373-5150 |
| ytanaka@kumamoto-u.ac.jp | |
| Affiliation | Kumamoto University Hospital Department of Gastroenterology and Hepatology |