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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT01311232
Eligibility Criteria:
Inclusion Criteria
1. Patients diagnosed with diffuse large B-cell lymphoma (DLBCL) or follicular B-cell lymphoma (FL).
2. Patients who had received at least two cycles of rituximab-CHOP or rituximab-CVP as a primary treatment
3. Patients with a history of previous exposure to HBV
* HBV surface antigen (HBs Ag) positive Or
* HBV core antibody (IgG anti-HBc antibody) positive
4. Patients with documented HBV reactivation (definite or presumptive) occurring during treatment (at least two cycles of R-CHOP or R-CVP) or within 12 months after the last dose of rituximab
* Definitive HBV reactivation
\- Elevation of serum HBV DNA level \>1 log IU/mL from baseline or absolute increase of HBV DNA by 6 log10 IU/mL in HBsAg positive patients
* Presumptive HBV reactivation - Increase of ALT (≥3x baseline value or absolute value of ≥100 U/L) and positive conversion of HBs Ag in previously HBsAg-negative patients
Exclusion Criteria:
1. Patients who had received chemotherapy other than R-CHOP or R-CVP after diagnosis
2. patients diagnosed with HIV, HCV or HDV co-infection
3. Patients who had undergone allogenic stem cell transplantation before hepatitis B virus reactivation was documented
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
90 Years
Study:
NCT01311232
Study Brief:
Protocol Section:
NCT01311232