Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy (NCT02081469) | Clinical Trial Compass
CompletedPhase 4
Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy
Taiwan100 participantsStarted 2014-03-17
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female 18 to 70 years of age
. Patients with histologically proven malignant tumor planned to receive chemotherapy after enrollment
. Hepatitis B virus (HBV) carriers who fulfill one of the following criteria:
. Patients with ALT ≤ 2 x ULN (upper limit of normal)
. Normal Cr mg/dL or eGFR \> 80 mL/min
. Life expectancy \> 1 year
. Willing and able to provide written informed consent
Exclusion criteria
. Females who are pregnant/nursing or with intention to be pregnant within the study period
. Documented hepatitis C virus (HCV) co-infection
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.