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NCT Number: NCT02081469

Prophylaxis of CHB Patients With Malignant Tumor Receiving Chemotherapy

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.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chang Gung Memorial Hospital

Taipei, 105, Taiwan

About this study

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 The subjects could be stopped or withdrawn from this study earlier if HBV relapses or need to receive another course of chemotherapy respectively.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TDF

Other

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

Other names: viread

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Gilead Sciences

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2014
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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