- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081469
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 105
- Chang Gung memorial hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
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).
- 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
- Current use of any hepatitis B prophylaxis medication
- Decompensated liver cirrhosis
- Current or previous use of any chemotherapy
- Use of any investigational product medicine within 1 month prior to the initiation of study treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Arm A:TDF for extend 24 weeks
Arm A:Continue TDF 300mg daily for extend 24 weeks after completion of chemotherapy
|
To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients
Other Names:
|
OTHER: Arm B: TDF for extend 48 weeks
Arm B: Continue TDF 300mg daily for extend 48 weeks after completion of chemotherapy.
|
To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 24 to 48 weeks
|
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. * HBV relapse is defined as: acute liver flare, i.e. ALT ≥ 2 x ULN and HBV DNA > 2000 IU/mL. |
24 to 48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To estimate the efficacy of TDF during chemotherapy with after chemotherapy and post-chemotherapy,as measure by the HBV reactivation, clinical relapse and adverse events in all patients.
Time Frame: The efficacy of TDF duration 24 wks versus 48 wks extended
|
AST, ALT, Bil(T), Cr (eGFR or MDRD), phosphate, urine analysis, HBsAgQT and HBV DNA were measured at baseline, every 2 cycle of chemotherapy, the end of chemotherapy, the end of TDF and the end of complete follow-up (after the end of TDF for 6 months).
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The efficacy of TDF duration 24 wks versus 48 wks extended
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chao-Wei Hsu, MD, Chang Gung medical Foundation, Linkou Branch
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IN-US-174-0207
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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