Clinical trial · Interventional
Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy
Phase IV; Different Extend Treatment Duration (6 Months vs 12 Months After Chemotherapy) to Prevent HBV Relapse With Tenofovir for Prophylaxis in Patients With Malignant Tumor Combined With HBV Carrier Receiving Chemotherapy
NCT02081469CI-TRIAL-00043164completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the effectiveness and safety of tenofovir for different treatment duration in preventing HBV relapse in patients with malignancies after receiving chemotherapy and off-treatment of chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B, Chronic | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TDF | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm A:TDF for extend 24 weeks
- description
- Arm A:Continue TDF 300mg daily for extend 24 weeks after completion of chemotherapy
- interventionNames
- Other: TDF
- type
- OTHER
- label
- Arm B: TDF for extend 48 weeks
- description
- Arm B: Continue TDF 300mg daily for extend 48 weeks after completion of chemotherapy.
- interventionNames
- Other: TDF
Primary outcomes (1)
- measure
- To compare the HBV relapse rate during the follow-up period in HBV carriers with malignant tumor receiving tenofovir for 24 and 48 weeks after the end of chemotherapy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female 18 to 70 years of age 2. Patients with histologically proven malignant tumor planned to receive chemotherapy after enrollment 3. Hepatitis B virus (HBV) carriers who fulfill one of the following criteria: seropositive of HBsAg, or HBsAg negative, but Anti-HBc positive with HBV DNA detectable defined as HBV DNA \> 20 IU/mL (by Roche Taqman real time assay). 4. Patients with ALT ≤ 2 x ULN (upper limit of normal) 5. Normal Cr mg/dL or eGFR \> 80 mL/min 6. Life expectancy \> 1 year 7. Willing and able to provide written informed consent Exclusion Criteria: 1. Females who are pregnant/nursing or with intention to be pregnant within the study period 2. Documented hepatitis C virus (HCV) co-infection 3. Patients with other current major systemic disease such as active infection, significant cardiac disease, poor control diabetes mellitus, osteopenia or osteoporosis that the investigators consider to be significant risk 4. Current use of any hepatitis B prophylaxis medication 5. Decompensated liver cirrhosis 6. Current or previous use of any chemotherapy 7. Use of any investigational product medicine within 1 month prior to the initiation of study treatment
References
Publications (1)
- DERIVEDHsu CW, Chen SC, Wang PN, Wang HM, Chen YC, Yeh CT. Preventing viral relapse with prophylactic tenofovir in hepatitis B carriers receiving chemotherapy: a phase IV randomized study in Taiwan. Hepatol Int. 2024 Apr;18(2):449-460. doi: 10.1007/s12072-023-10635-5. Epub 2024 Feb 20. PMID 38376651