Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)

September 26, 2018 updated by: Tian-Tian Cheng, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B

The study will explore the characteristics in clinical pharmacokinetics of gefitinib, erlotinib,afatinib,osimertinib, crizotinib, apatinib, icotinib in Chinese patients of Non-small-cell lung cancer and hepatitis B. The study is self-controlled. The plasma concentration of tyrosine kinase inhibitors will be analyzed before and after system treatment of HBV.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Tyrosine kinase inhibitors (TKIs) are first line treatment for non-small-cell lung cancer patients with mutations in targeted genes. TKIs are metabolized in liver into inactive metabolites before eliminating from body. Liver function might plays a significant role in inter-individual differences of pharmacokinetics of TKIs. Hepatitis B is a disease of high prevalence in south China. The liver function will be compromised if the infection of hepatitis B virus has not been controlled. This study aims to compare the pharmacokinetics of TKIs before and after controlling HBV with standard treatment in Chinese patients of non-small-cell lung cancer.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wenying Shu, PhD
  • Phone Number: 2006 86-20-66673666
  • Email: 790840799@qq.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510182
        • Recruiting
        • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chinese patients diagnosed of non-small-cell lung cancer. Controlled group are HBV negative and HBV group are diagnosed of chronic hepatitis B. All subjects should be able to make their own decision and sign informed concerned.

Description

Inclusion Criteria:

  • pathological confirmed non-small-cell lung cancer
  • with epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genetic mutation required by different TKIs
  • liver function, ALT and/or AST <= 2*upper limit of normal (ULN)
  • diagnosed of chronic hepatitis B
  • Hepatitis B negative as controlled group
  • receiving one type of TKIs
  • Age between 18-70

Exclusion Criteria:

  • diagnosed of acute/ active hepatitis B
  • diagnosed of AIDS
  • unable to make decision because of metastasis to central nervous system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-exposure
Entecavir 1Mg Oral Tablet
Drug: Entecavir 1Mg Oral Tablet
The anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST)
Other Names:
  • Bicyclol Tablets
Post-exposure
Entecavir 1Mg Oral Tablet
Drug: Entecavir 1Mg Oral Tablet
The anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST)
Other Names:
  • Bicyclol Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average plasma concentration of the drugs (TKIs)
Time Frame: one year after recruit
compare the concentration of TKIs prior to and after anti-HBV treatment
one year after recruit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse reaction caused by TKIs
Time Frame: one year after recruit
the adverse reaction of TKIs before and after anti-HBV treatment
one year after recruit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Investigators

  • Study Director: Shuzhong Cui, MD, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

September 13, 2018

First Submitted That Met QC Criteria

September 19, 2018

First Posted (Actual)

September 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTKI-HBV-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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