NCT07203118

Brief Summary

UsingTAF as the control, the nvestigators aim to further explore the efficacy and safety of different dosages of HTS in the treatment of patients with chronic hepatitis B; ultimately, the nvestigators determine the optimal recommended dosage of HTS to provide a basis for Phase III confirmatory clinical research.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,444

participants targeted

Target at P75+ for phase_2

Timeline
47mo left

Started Jul 2025

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress18%
Jul 2025Feb 2030

Study Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2030

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2 years

First QC Date

September 15, 2025

Last Update Submit

September 23, 2025

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related adverse events of the Optimal Dosing Regimen as assessed by CTCAE v5.0

    through study completion, an average of 1 year

Study Arms (4)

HTS 20mg

EXPERIMENTAL
Drug: HTS 20mg

HTS 30mg

EXPERIMENTAL
Drug: HTS 30mg

HTS 40mg

EXPERIMENTAL
Drug: HTS 40mg

TAF 25mg

EXPERIMENTAL
Drug: TAF 25mg

Interventions

HTS 20mgDRUG

Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

HTS 20mg
HTS 30mgDRUG

Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

HTS 30mg
HTS 40mgDRUG

Once daily, administered concomitantly with one TAF placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

HTS 40mg
TAF 25mgDRUG

Once daily, administered concomitantly with one HTS placebo tablet per dose, taken once daily with or within 30 minutes after a meal.

TAF 25mg

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ）Age between 18 to 65 years old (inclusive), regardless of gender. 2) Meets diagnostic criteria for chronic hepatitis B (documented HBsAg positivity or HBV DNA positivity for more than 6 months, or confirmed by liver biopsy histopathology).
  • )No prior treatment with any nucleos(t)ide analogue oral antiviral therapy; or, previous treatment with any nucleos(t)ide analogue must have ended at least 6 months prior to baseline.
  • \) Any interferon therapy (both pegylated and non-pegylated) must be completed at least 1 year prior to baseline visit.
  • \) Willing to use effective non-pharmacological contraception during the trial period.

You may not qualify if:

  • Hypersensitive to the study drug, its metabolites or any excipient in its formula;
  • With previous or present clinical hepatic decompensation (e.g., ascites, hepatic encephalopathy or varicose vein haemorrhage)
  • Complicated with liver diseases, including chronic alcoholic hepatitis, drug-induced hepatitis, etc.
  • Complicated with HCV, HIV or HDV infections
  • Documented resistance to the antiviral drug (Tenofovir).
  • Any cardiovascular, hematologic,pulmonary or nervous diseases deemed serious by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Hospital of Jilin University

Jilin, changchun, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2025

First Posted

October 2, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

February 28, 2030

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)