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
1 other identifier
interventional
88
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2023
Typical duration for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2023
CompletedFirst Posted
Study publicly available on registry
November 29, 2023
CompletedStudy Start
First participant enrolled
December 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedNovember 14, 2024
November 1, 2024
2 years
November 20, 2023
November 13, 2024
Conditions
Outcome Measures
Primary Outcomes (4)
The incidence of adverse events (AEs)
The incidence of adverse events (AEs) during treatment
Up to 48 weeks
Severity of adverse events (AEs)
The severity of adverse events (AEs) during treatment
Up to 48 weeks
Incidence of serious adverse events (SAEs)
The incidence of serious adverse events (SAEs) during treatment
Up to 48 weeks
Severity of serious adverse events (SAEs)
The severity of serious adverse events (SAEs) during treatment
Up to 48 weeks
Secondary Outcomes (17)
Incidence of abnormal laboratory test values
Up to 48 weeks
Severity of abnormal laboratory test values
Up to 48 weeks
Deoxyribonucleic acid level of hepatitis B virus
At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Hepatitis B surface antigen
At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
Hepatitis B e antigen
At week 12, week 24, week 36 and week 48 or when subjects withdrawal from the study
- +12 more secondary outcomes
Study Arms (8)
Placebo +Nucleoside (acid) analogs (NAs) combination therapy 24 weeks
PLACEBO COMPARATORPlacebo and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks.
50 mg of TQA3605 tablets +NAs combination therapy 24 weeks
ACTIVE COMPARATOR50 mg of TQA3605 tablets and Nucleoside (acid) analogues, taken orally once daily, continue for 24 weeks.
100 mg of TQA3605 tablets +NAs combination therapy 48 weeks
ACTIVE COMPARATORTQA3605 is taken orally 100mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks.
200 mg of TQA3605 tablets +NAs combination therapy 48 weeks
ACTIVE COMPARATORTQA3605 is taken orally 200mg once daily; Nucleoside (acid) analogues were used once daily for 48 weeks.
Placebo +Nucleoside (acid) analogs (NAs) combination therapy
PLACEBO COMPARATORPlacebo taken orally once daily, continue for 12 weeks. Placebo was then combined with nucleoside (acid) analogues (once daily) for 36 weeks
100 mg of TQA3605 tablets +NAs combination therapy
ACTIVE COMPARATORTQA3605 was taken orally 100mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks.
200 mg of TQA3605 tablets +NAs combination therapy
ACTIVE COMPARATORTQA3605 was taken orally 200mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks.
300 mg of TQA3605 tablets+NAs combination therapy
ACTIVE COMPARATORTQA3605 was taken orally 300mg once a day for 12 weeks. It was then combined with nucleoside (acid) analogues (once daily) for 36 weeks.
Interventions
TQA3605 placebo tablets were orally administered on an empty stomach (at least 2 hours before or after meals) with warm.
TQA3605 inhibits viral replication.
Entecavir inhibits viral replication and indicated for chronic hepatitis B treatment.
Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor.
Tenofovir alafenamide fumarate inhibits hepatitis B virus replication.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, 710061, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2023
First Posted
November 29, 2023
Study Start
December 7, 2023
Primary Completion
December 1, 2025
Study Completion (Estimated)
September 1, 2026
Last Updated
November 14, 2024
Record last verified: 2024-11