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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06150014
Other study ID # TQA3605-Ib/IIa-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 7, 2023
Est. completion date December 2024

Study information

Verified date November 2023
Source Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Contact Qing Mao, Doctorc
Phone 13594180020
Email qingmao@yahoo.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, double-blind Phase Ib/IIa multicenter trial. All eligible subjects will receive TQA3605 tablets or placebo in combination with nucleoside (acid) analogues. A total of 64 subjects will be enrolled.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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; - A history of malignant tumors within the past 5 years; - Interstitial lung disease, acute lung disease, etc.; - Uncontrolled systemic diseases such as high blood pressure and diabetes; - Have used any investigational drug or participated in a clinical trial within one month prior to the administration of study drug; - Those who received live attenuated vaccine within 28 days before the start of study treatment, inactivated vaccine within 7 days, or planned vaccination during the study period; - The investigator determines that there is any medical or psychiatric condition that puts the subject at risk, interferes with participation in the study, or interferes with the interpretation of the study results; - Female subjects that were pregnant, lactating or had a positive pregnancy result during the screening period or during the trial; Male and female patients with reproductive potential who were unwilling to use effective contraceptive methods during the study period; - Subjects who have any medical condition that may affect the absorption of oral drugs; - Within 12 weeks prior to screening, treated chronic hepatitis B patients who had stopped taking nucleoside (acid) analogues for more than 14 consecutive days; - Those considered unsuitable for enrollment by the investigators.

Study Design


Intervention

Drug:
Placebo
TQA3605 placebo tablets were orally administered under fast condition (at least 2 hours before or after meals) with warm water for a total of 24 weeks.
TQA3605 tablets
TQA3605 inhibits viral replication.
Entecavir dispersible tablets
Entecavir inhibits viral replication and indicated for chronic hepatitis B treatment.
Tenofovir disoproxil fumarate tablet
Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor.
Tenofovir alafenamide fumarate tablet
Tenofovir alafenamide fumarate inhibits hepatitis B virus replication.

Locations

Country Name City State
China The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University Chongqing Chongqing
China The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shannxi

Sponsors (1)

Lead Sponsor Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of adverse events (AEs) The incidence of adverse events (AEs) during treatment Up to 28 weeks
Primary Severity of adverse events (AEs) The severity of adverse events (AEs) during treatment Up to 28 weeks
Primary Incidence of serious adverse events (SAEs) The incidence of serious adverse events (SAEs) during treatment Up to 28 weeks
Primary Severity of serious adverse events (SAEs) The severity of serious adverse events (SAEs) during treatment Up to 28 weeks
Secondary Incidence of abnormal laboratory test values The incidence of abnormal laboratory values during treatment, e.g. triglycerides. Up to 28 weeks
Secondary Severity of abnormal laboratory test values The severity of abnormal laboratory values during treatment, e.g. triglycerides. Up to 28 weeks
Secondary Deoxyribonucleic acid level of hepatitis B virus Changes in hepatitis B virus deoxyribonucleic acid (HBV DNA) levels from baseline At week 12 and week 24 or when subjects withdrawal from the study
Secondary Hepatitis B surface antigen Changes in serum hepatitis B surface antigen (HBsAg) from baseline At week 12 and week 24 or when subjects withdrawal from the study
Secondary Hepatitis B e antigen Changes in serum hepatitis B e antigen (HBeAg) from baseline At week 12 and week 24 or when subjects withdrawal from the study
Secondary Serologic clearance and/or serologic conversion of HBsAg Proportion of subjects with HBsAg serologic clearance and/or serologic conversion At week 12 and week 24 or when subjects withdrawal from the study
Secondary Serologic clearance and/or serologic conversion of HBeAg Proportion of subjects with HBeAg serologic clearance and/or serologic conversion At week 12 and week 24 or when subjects withdrawal from the study
Secondary Virological breakthrough rate The proportion of subjects who achieved a virological breakthrough (defined as a confirmed increase of HBV DNA levels >1.0 log10 IU/ml from the minimum during treatment). At week 12 and week 24 or when subjects withdrawal from the study
Secondary Peak time (Tmax) Time to reach peak blood concentration after a single dose pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Peak concentration The highest plasma drug concentration that can be achieved after medication pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Area under blood concentration-time curve (AUC) The amount of drug absorbed into the human circulation after a single dose can be estimated using the area under the blood concentration-time curve pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Apparent volume of distribution (Vd/F) When a drug reaches homeostasis in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution. pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Plasma clearance The amount of plasma that the kidneys completely clear in unit time (per minute). pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Elimination half-life The time it takes for the plasma concentration to drop by half. pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Steady state peak time The time required to reach peak steady-state concentration after administration pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Steady state maximum concentration The highest blood concentration that occurs after stabilization pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
Secondary Steady state minimal concentration The lowest blood concentration that occurs after stabilization pre-dose, 30 minutes, 1 , 2 , 4 , 6 , 12, 24 hours after administration on Day 1; pre-dose on Day 8 and Day 9; pre-dose, 30 minutes, 1, 2, 4, 6, 12, 24 hours after administration on Day 10.
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