Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT02081469
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02081469
Study Brief:
Protocol Section:
NCT02081469