Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04539119
Status:
UNKNOWN
Last Update Posted:
2020-09-04
First Post:
2020-08-28
Brief Title:
Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Comparative Study of the Efficacy and Safety of Entecavir and Tenofovir Versus Entecavir Alone in the Treatment of Hepatitis B DNA-positive Patients With Lymphomas
Status:
UNKNOWN
Status Verified Date:
2020-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center open-label randomized controlled trial aimed to evaluate the efficacy and safety of entecavir and tenofovir versus entecavir alone in the antiviral treatment of HBV DNA positive B-cell lymphoma patients
This study plans to enroll about 120 participants in total Recruitment will last for 2 years
The study visit will take place on the first day of each cycle of therapy until the end of the treatment
Participants who meet the inclusionexclusion criteria were randomly assigned to receive entecavir and tenofovir or entecavir alone after signing the informed consent HBV DNA will be measured before each cycle of chemotherapy or immunotherapy When the copy count of HBV DNA drops below 1103L entecavir single agent will be given orally until one year after the cycle of therapy
Treatment response will be evaluated routinely after chemotherapy or immunotherapy
Within 2 years after the last participant is enrolled participants survival information will collected by telephone andor clinical visit every 3 months after the last visit ie date and cause of death subsequent cancer treatment etc if there is no withdrawal of the informed consent form
This study plans to enroll about 120 participants in total Recruitment will last for 2 years
The study visit will take place on the first day of each cycle of therapy until the end of the treatment
Participants who meet the inclusionexclusion criteria were randomly assigned to receive entecavir and tenofovir or entecavir alone after signing the informed consent HBV DNA will be measured before each cycle of chemotherapy or immunotherapy When the copy count of HBV DNA drops below 1103L entecavir single agent will be given orally until one year after the cycle of therapy
Treatment response will be evaluated routinely after chemotherapy or immunotherapy
Within 2 years after the last participant is enrolled participants survival information will collected by telephone andor clinical visit every 3 months after the last visit ie date and cause of death subsequent cancer treatment etc if there is no withdrawal of the informed consent form
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None