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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

NCT06150014 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2024-11-14

No results posted yet for this study

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

Conditions

Interventions

DRUG

Placebo

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

DRUG

TQA3605 tablets

TQA3605 inhibits viral replication.

DRUG

Entecavir dispersible tablets

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

DRUG

Tenofovir disoproxil fumarate tablet

Tenofovir disoproxil fumarate is a Nucleotide reverse transcriptase inhibitor.

DRUG

Tenofovir alafenamide fumarate tablet

Tenofovir alafenamide fumarate inhibits hepatitis B virus replication.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-07
Primary Completion
2025-12-31
Completion
2026-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06150014 on ClinicalTrials.gov