Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

NCT ID: NCT02081469

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-17
• Study Completion Date: 2019-08-05

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 The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively.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

Conditions

Hepatitis B, Chronic; Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Arm A:TDF for extend 24 weeks

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

Group Type: OTHER

TDF

Intervention Type: OTHER

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

Arm B: TDF for extend 48 weeks

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

Group Type: OTHER

TDF

Intervention Type: OTHER

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

Interventions

TDF

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

Intervention Type: OTHER

Other Intervention Names

viread

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chao-Wei Hsu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chao-Wei Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Medical Foundation (Linkou Branch)

Locations

Chang Gung Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Hsu CW, Chen SC, Wang PN, Wang HM, Chen YC, Yeh CT. Preventing viral relapse with prophylactic tenofovir in hepatitis B carriers receiving chemotherapy: a phase IV randomized study in Taiwan. Hepatol Int. 2024 Apr;18(2):449-460. doi: 10.1007/s12072-023-10635-5. Epub 2024 Feb 20.

Reference Type: DERIVED

PMID: 38376651 (View on PubMed)

Other Identifiers

IN-US-174-0207

Identifier Type: -

Identifier Source: org_study_id