Zinc Sulphate in Treatment Fibrosis in HBV Patient Receiving Antiviral Therapy

ConditionsLiver Fibroses HBV (Hepatitis B Virus)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorTanta University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with fibrosis stage (F2&F3) post chronic HBV infection receiving standard antiviral therapy.

Age > 18 and < 65 years.

Disqualifiers

Patients with prior history of liver transplantation.

Patients with prior history of hepatocellular carcinoma.

Patients coinfected with HIV or HCV.

Patients with any malignancies.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

44 Participants

are divided into 2 treatment groups

Group A: (control group)Placebo comparator 1 intervention

Group B: (zinc group)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Change in fibrosis scores.

Time frame

6 months

Secondary outcomes

Change in serum biomarkers

The secondary outcome is decrease in serum levels of the measured biological markers which are (fibronectin \& HA)

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: