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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03680183
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Tian-Tian Cheng, Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Hepatitis B Drug: Entecavir 1Mg Oral Tablet

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

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 Name: 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 Name: Bicyclol Tablets




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of adverse reaction caused by TKIs [ Time Frame: one year after recruit ]
    the adverse reaction of TKIs before and after anti-HBV treatment


Biospecimen Retention:   Samples Without DNA
5ml of whole blood is collected before and after the anti-HBV treatment to measure the plasma concentration of TKIs


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680183


Contacts
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Contact: Wenying Shu, PhD 86-20-66673666 ext 2006 790840799@qq.com

Locations
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China, Guangdong
Affiliated Cancer Hospital & Institute of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510182
Contact: Wenying Shu, PhD    86-20-66673666 ext 2006    790840799@qq.com   
Contact: Tiantian Cheng, MD    86-20-66673677    gyzlgcp@163.com   
Sponsors and Collaborators
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Investigators
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Study Director: Shuzhong Cui, MD Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Additional Information:

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Responsible Party: Tian-Tian Cheng, Secretary of GCP, Affiliated Cancer Hospital & Institute of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT03680183    
Other Study ID Numbers: PTKI-HBV-01
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Tian-Tian Cheng, Affiliated Cancer Hospital & Institute of Guangzhou Medical University:
Tyrosine kinase inhibitors
pharmacokinetics
Hepatitis B
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents