NCT02081469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

March 17, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

February 5, 2020

Status Verified

January 1, 2020

Enrollment Period

5.4 years

First QC Date

March 4, 2014

Last Update Submit

January 30, 2020

Conditions

Hepatitis B, ChronicTumor

Keywords

Chronic hepatitis BHBVChemotherapyReactivationProphylaxis

Outcome Measures

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.

    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 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.

    The efficacy of TDF duration 24 wks versus 48 wks extended

Study Arms (2)

Arm A:TDF for extend 24 weeks

OTHER

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

Other: TDF

Arm B: TDF for extend 48 weeks

OTHER

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

Other: TDF

Interventions

TDFOTHER

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

Also known as: viread
Arm A:TDF for extend 24 weeksArm B: TDF for extend 48 weeks

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 38376651DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicNeoplasms

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Chao-Wei Hsu, MD

    Chang Gung Medical Foundation (Linkou Branch)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Tenofovir 300mg QD. Two arm: 6 month and 12 month.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 7, 2014

Study Start

March 17, 2014

Primary Completion

August 5, 2019

Study Completion

August 5, 2019

Last Updated

February 5, 2020

Record last verified: 2020-01

Locations

TW(1)