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A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic Hepatitis B

NCT06150014•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

A randomized, double-blind Phase Ib/IIa multicenter trial design was used. All eligible subjects received TQA3605 tablets/placebo plus nucleoside (acid) analogues. A total of 88 subjects were required

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects voluntarily participate in this study and sign informed consent;
•Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
•Patients diagnosed with chronic hepatitis B (CHB) who have been serum HBsAg positive for more than 6 months and HBeAg positive or negative ;
•The liver fibrosis ultrasound transient imaging elastic technology (Fibroscan/FibroTouch) showed that the liver hardness (LSM) was less than 12.4 Kpa;
•Patients with chronic hepatitis B after treatment;
•Treatment-naïve patients of chronic hepatitis B patients;

Exclusion Criteria

•Complicated with other infected disease such as hepatitis A virus (HAV), hepatitis C virus (HCV), Hepatitis D virus (HDV), hepatitis E virus (HEV), human immunodeficiency virus (HIV), syphilis (syphilis antibody positive and need treatment determined by the investigator);
•Abdominal ultrasound or other imaging or histology showed suspected cirrhosis or other liver disease before or during screening;
•Patients have a history of hepatocellular carcinoma (HCC) before or at the time of screening, or may be at risk for HCC;
•Active autoimmune disease diagnosed with immunodeficiency or undergoing systemic therapy which was continuing within 2 weeks before first dosing;
•Currently being treated with nephrotoxic drugs or drugs that alter renal excretion;
•Abnormal thyroid function;
•Renal diseases such as chronic kidney disease and renal insufficiency or creatinine clearance (CLCr) \<60 ml/min during the screening period;
•Hematologic and biochemical abnormalities;
•History of allergy to the investigational drug or its excipients;
•Recipients of solid organs or bone marrow transplants;
+10 more criteria

Locations (3)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shannxi, China

Key Dates

Start Date

December 7, 2023

Primary Completion Date

December 1, 2025

Completion Date

September 1, 2026

Last Updated

November 14, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis b

Interventions

Placebo

DRUG

TQA3605 tablets

DRUG

Entecavir dispersible tablets

DRUG

Tenofovir disoproxil fumarate tablet

DRUG

Tenofovir alafenamide fumarate tablet

DRUG

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

NCT06671093

Chronic Hep BChronic Hepatitis b+2 more

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RECRUITINGPHASE1

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

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Chronic Hepatitis b

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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: November 14, 2024Data 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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A Clinical Study of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment Naive and Treated Patients With Chronic Hepatitis B

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

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