Clinical trial NCT02081469: Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Tumor
Keywords: Chronic hepatitis B
HBV
Chemotherapy
Reactivation
Prophylaxis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2014-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Tenofovir 300mg QD. Two arm: 6 month and 12 month.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: This study aims to evaluate the effectiveness and safety of tenofovir in preventing HBV relapse in HBV carriers with malignant tumor following chemotherapy. Approximately 100 patients who are planned to receive chemotherapy for malignant tumor will be invited to participate in this trail. A 1 or less 1-week tenofovir prophylaxis treatment should be administered by all subjects prior to the chemotherapy and eligible subjects will be randomly assigned to extend 24-week prophylaxis group A or 48-week prophylaxis group B in a 1:1 ratio at the end of the chemotherapy. The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively. The relapse episode will be followed until 24 weeks after the end of prophylaxis therapy. Data collection will take place at screening, every cyclic visit of chemotherapy, at the end of chemotherapy, and the following prophylaxis period, then every 4 weeks during the follow-up period. Patients in both groups will be treated with tenofovir or other antiviral agent according to investigator judgement when HBV relapse after discontinuation of tenofovir therapy.

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

Primary outcomes:
measure: 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.
timeFrame: 24 to 48 weeks
Secondary outcomes:
measure: 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.
timeFrame: The efficacy of TDF duration 24 wks versus 48 wks extended
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Medical Foundation (Linkou Branch)
name: Chao-Wei Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: