Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

Hepatitis B, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02081469
• Other study ID #: IN-US-174-0207
• Status: Completed
• Phase: Phase 4
• Start date: March 17, 2014
• Est. completion date: August 5, 2019

Study information

• Verified date: January 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 5, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Neoplasms
• Tumor

Intervention

Other:
• TDF
To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	Gilead Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 to 48 weeks
Secondary	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).	The efficacy of TDF duration 24 wks versus 48 wks extended