Clinical trial · Observational
Clinical Pharmacokinetics of TKIs in Chinese Patients of Hepatitis B (HBV)
Clinical Pharmacokinetics of Tyrosine Kinase Inhibitors in Chinese Patients of Hepatitis B
NCT03680183CI-TRIAL-00035075unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir 1Mg Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pre-exposure
- description
- Entecavir 1Mg Oral Tablet
- interventionNames
- Drug: Entecavir 1Mg Oral Tablet
- label
- Post-exposure
- description
- Entecavir 1Mg Oral Tablet
- interventionNames
- Drug: Entecavir 1Mg Oral Tablet
Primary outcomes (1)
- measure
- Average plasma concentration of the drugs (TKIs)
- timeFrame
- one year after recruit
- description
- compare the concentration of TKIs prior to and after anti-HBV treatment
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.