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

Phase 2Active Not RecruitingNCT06150014

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.88 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Chronic Hepatitis b

Interventions

PlaceboDRUG

TQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm.

TQA3605 tabletsDRUG

TQA3605 inhibits viral replication.

Entecavir dispersible tabletsDRUG

Entecavir inhibits viral replication and indicated for chronic hepatitis B treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

The incidence of adverse events (AEs)

The incidence of adverse events (AEs) during treatment

Time frame: Up to 48 weeks

Severity of adverse events (AEs)

The severity of adverse events (AEs) during treatment

Time frame: Up to 48 weeks

Incidence of serious adverse events (SAEs)

The incidence of serious adverse events (SAEs) during treatment

Time frame: Up to 48 weeks

Severity of serious adverse events (SAEs)

The severity of serious adverse events (SAEs) during treatment

Time frame: Up to 48 weeks

Secondary Outcomes

Incidence of abnormal laboratory test values

The incidence of abnormal laboratory values during treatment, e.g. triglycerides.

Time frame: Up to 48 weeks

Severity of abnormal laboratory test values

The severity of abnormal laboratory values during treatment, e.g. triglycerides.

Time frame: Up to 48 weeks

Deoxyribonucleic acid level of hepatitis B virus

Changes in hepatitis B virus deoxyribonucleic acid (HBV DNA) levels from baseline

Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study

Hepatitis B surface antigen

Changes in serum hepatitis B surface antigen (HBsAg) from baseline

Data from ClinicalTrials.gov

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Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor.

Tenofovir alafenamide fumarate tabletDRUG

Tenofovir alafenamide fumarate inhibits hepatitis B virus replication.

Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study

Hepatitis B e antigen

Changes in serum hepatitis B e antigen (HBeAg) from baseline

Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study

Serologic clearance and/or serologic conversion of HBsAg

Proportion of subjects with HBsAg serologic clearance and/or serologic conversion

Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study

Serologic clearance and/or serologic conversion of HBeAg

Proportion of subjects with HBeAg serologic clearance and/or serologic conversion

Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study

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).

Time frame: At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study

Peak time (Tmax)

Time to reach peak blood concentration after a single dose

Time frame: 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.

Peak concentration

The highest plasma drug concentration that can be achieved after medication

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

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.

Plasma clearance

The amount of plasma that the kidneys completely clear in unit time (per minute).

Elimination half-life

The time it takes for the plasma concentration to drop by half.

Steady state peak time

The time required to reach peak steady-state concentration after administration

Steady state maximum concentration

The highest blood concentration that occurs after stabilization

Steady state minimal concentration

The lowest blood concentration that occurs after stabilization