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

NCT ID: NCT03680183

Last Updated: 2018-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer Hepatitis B

Keywords

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Tyrosine kinase inhibitors pharmacokinetics Hepatitis B

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-exposure

Entecavir 1Mg Oral Tablet

Entecavir 1Mg Oral Tablet

Intervention Type DRUG

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)

Post-exposure

Entecavir 1Mg Oral Tablet

Entecavir 1Mg Oral Tablet

Intervention Type DRUG

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)

Interventions

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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)

Intervention Type DRUG

Other Intervention Names

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Bicyclol Tablets

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Tian-Tian Cheng

Secretary of GCP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shuzhong Cui, MD

Role: STUDY_DIRECTOR

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Locations

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Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wenying Shu, PhD

Role: CONTACT

Phone: 86-20-66673666

Email: [email protected]

Facility Contacts

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Wenying Shu, PhD

Role: primary

Tiantian Cheng, MD

Role: backup

Other Identifiers

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PTKI-HBV-01

Identifier Type: -

Identifier Source: org_study_id