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Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

Primary Purpose

Hepatitis B, Chronic, Tumor

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
TDF
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hepatitis B, Chronic focused on measuring Chronic hepatitis B, HBV, Chemotherapy, Reactivation, Prophylaxis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arm A:TDF for extend 24 weeks

Arm B: TDF for extend 48 weeks

Arm Description

Arm A:Continue TDF 300mg daily for extend 24 weeks after completion of chemotherapy

Arm B: Continue TDF 300mg daily for extend 48 weeks after completion of chemotherapy.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
March 4, 2014
Last Updated
January 30, 2020
Sponsor
Chang Gung Memorial Hospital
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02081469
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 17, 2014 (Actual)
Primary Completion Date
August 5, 2019 (Actual)
Study Completion Date
August 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
Collaborators
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic, Tumor
Keywords
Chronic hepatitis B, HBV, Chemotherapy, Reactivation, Prophylaxis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Tenofovir 300mg QD. Two arm: 6 month and 12 month.
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A:TDF for extend 24 weeks
Arm Type
Other
Arm Description
Arm A:Continue TDF 300mg daily for extend 24 weeks after completion of chemotherapy
Arm Title
Arm B: TDF for extend 48 weeks
Arm Type
Other
Arm Description
Arm B: Continue TDF 300mg daily for extend 48 weeks after completion of chemotherapy.
Intervention Type
Other
Intervention Name(s)
TDF
Other Intervention Name(s)
viread
Intervention Description
To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
24 to 48 weeks
Secondary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
The efficacy of TDF duration 24 wks versus 48 wks extended

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chao-Wei Hsu, MD
Organizational Affiliation
Chang Gung Medical Foundation, Linkou Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taipei
ZIP/Postal Code
105
Country
Taiwan

12. IPD Sharing Statement

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Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

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