NCT07145268

Brief Summary

This study aims to investigate the possible safety and efficacy of Zinc sulphate as antifibrotic agent in chronic HBV patient receiving antiviral therapy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
4mo left

Started Sep 2025

Shorter than P25 for phase_2

Status
not yet 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 Progress68%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

August 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 20, 2025

Last Update Submit

August 20, 2025

Conditions

Liver FibrosesHBV (Hepatitis B Virus)

Outcome Measures

Primary Outcomes (1)

  • Change in fibrosis scores.

    6 months

Secondary Outcomes (1)

  • Change in serum biomarkers

    6 months

Study Arms (2)

(control group)

PLACEBO COMPARATOR

22 patients will continue their standard antiviral therapy (Entecavir 0.5 mg) for 6 months.

Drug: Entecavir (ETV)

(zinc group)

ACTIVE COMPARATOR

22 patients will receive Zinc suIphate 220 mg orally once daily (equivalent to 50 mg elemental zinc), in addition to their standard antiviral therapy (Entecavir 0.5 mg), for 6 months.

Drug: Zinc (zinc sulphate)

Interventions

Entecavir (ETV)DRUG

Standard antiviral therapy with Entecavir 0.5 mg orally once daily for 6 months."(control group)

(control group)
Zinc (zinc sulphate)DRUG

Zinc sulfate 220 mg orally once daily (50 mg elemental zinc) in addition to Entecavir 0.5 mg, for 6 months."

(zinc group)

Eligibility Criteria

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

You may qualify if:

  • Patients with fibrosis stage (F2\&F3) post chronic HBV infection receiving standard antiviral therapy.
  • Age \> 18 and \< 65 years.

You may not qualify if:

  • Patients with prior history of liver transplantation.
  • Patients with prior history of hepatocellular carcinoma.
  • Patients coinfected with HIV or HCV.
  • Patients with any malignancies.
  • Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver CirrhosisHepatitis B

Interventions

entecavirZincZinc Sulfate

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsZinc Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical pharmacist

Study Record Dates

First Submitted

August 20, 2025

First Posted

August 28, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 28, 2025

Record last verified: 2025-08