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Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients | Clinical Trials | Clareo Health

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Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

A Phase II Clinical Trial to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

NCT04189276•Tasly Tianjin Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

A multi-center, randomized, open-label, group controlled study to evaluate the safety and efficacy of T101 combined with nucleoside (acid) analogues in chronic hepatitis B patients.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\. Patients between the ages of 18 and 60 years, male or female;
•2\. Body weight is no less than 45kg for female and no less than 50kg for male;
•3\. Meets the diagnosis and treatment standards of chronic hepatitis B in China's 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B;
•4\. Currently, should have taken nucleoside (acid) analogues for 1 year or more;
•5\. HBV DNA\<100 IU/ml; HBsAg is positive and no more than 3000 IU/ml；HBeAg is negative；
•6\. Be able to understand and sign informed consent.

Exclusion Criteria

•Patients with any of the following items will not be enrolled in this study:
•1\. Pregnant or lactating women; male or female who have planned to have children from the start of the study to sixth month after the end of the study.
•2\. Have received interferon treatment within 6 months prior to the screening;
•3\. Have taken strong immunomodulators (such as adrenocortical hormone, thymosin alpha 1, thymosin 5, etc.) within 6 months before the screening, and the course of treatment was more than 2 weeks;
•4\. Have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) within 6 months before screening, and the course of treatment was more than 2 weeks;
•5\. Currently or previously diagnosed or suspected with cirrhosis or liver cancer; or AFP \> 50ng/ml;
•6\. Liver diseases caused by other causes: including alcoholic hepatitis, drug hepatitis, autoimmune liver disease;
•7\. Currently be infected of HAV, HCV, HDV, HEV, HIV and syphilis;
•8\. Have mental diseases, including but not limited to depression, anxiety, mania, schizophrenia;
•9\. Uncontrolled epilepsy;
+10 more criteria

Locations (3)

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Beijing Ditan Hospital Capital Medical University

Beijing, Beijing Municipality, China

Tianjin Second People's Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

December 10, 2019

Primary Completion Date

June 30, 2021

Completion Date

December 1, 2021

Last Updated

February 8, 2021

Enrollment

100

ACTUAL participants

Conditions

Hepatitis B Virus (HBV)

Interventions

ETV/TDF+T101 No.1

BIOLOGICAL

ETV/TDF+T101 No.2

BIOLOGICAL

ETV or TDF

BIOLOGICAL

ETV/TDF+Peg-IFNα-2b

BIOLOGICAL

Rapid HIV, Hep C, and Syphilis Screening in a Rural Street Medicine Clinic

NCT07317687

HIV TestingHEPATITIS C (HCV)+2 more

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NCT07274345

Chronic Hepatitis B - Antiviral Drug Resistance - Hepatitis B Virus (HBV) Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Therapeutic Hepatitis B Adenovirus Injection (T101) Combined With Nucleoside (Acid) Analogues in Chronic Hepatitis B Patients

Inclusion Criteria

Exclusion Criteria

Rapid HIV, Hep C, and Syphilis Screening in a Rural Street Medicine Clinic

Prevalence and Risk Factors of Antiviral Resistance in Egyptian HBV Patients

Sonoelastography: Ultrasound Method to Measure Liver Fibrosis