NCT05465434

Brief Summary

This study aims to evaluate the possible antifibrotic effect of zinc sulphate in chronic HCV patient receiving direct acting anti-viral therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

July 13, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

July 13, 2022

Last Update Submit

October 14, 2023

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (6)

  • Abdominal Ultrasonography

    Assessment the change in the degree of liver fibrosis post treatment and compare their results before and post treatment

    3 months

  • Serum fibronectin level

    Fibronectin (FN), which is produced by hepatic stellate cells (HSCs), participates in cell adhesion and proliferation, and has an important role in fibrotic progression, excessive FN deposition occurs prior to collagen deposition

    3 months

  • Serum transforming growth factor - beta 1 (TGF- β1) level

    Transforming growth factor (TGF)-β is a good noninvasive marker for the assessment of liver fibrosis in patients with chronic HCV and also considered as a master profibrogenic cytokine and a promising target to treat fibrosis (15)

    3 months

  • Fibrosis-4 (FIB-4) Score

    The Fibrosis 4 score is a non-invasive scoring system based on several laboratory tests (AST/ALT/Platelets) that help to non-invasively estimate the amount of scarring in the liver. This score has been studied in liver disease due to Hepatitis C and Non-alcoholic steatohepatitis (NASH) FIB-4 = (Age (years)XAST Level (U/L))/(Platelet Count (〖10〗\^9/L) X √(ALT (U/L))) FIB-4\>3.25 confirms the presence of advanced fibrosis (F4) FIB-4\<1.45 exclude the presence of advanced fibrosis (F3-F4) Values between 1.45 and 3.25 did not fully discriminate fibrosis and would need an additional method to predict liver fibrosis

    3 months

  • AST to Platelet Ratio Index (APRI) score

    The APRI model was developed as a simple, easily calculated method to predict significant, severe fibrosis (or cirrhosis) and has been tested in persons with HCV mono-infection and those with HCV and HIV Co-infection APRI = (AST Level /AST (Upper Limit of Normal))/(Platelet Count (〖10〗\^9/L) )X100 If the score is less than or equal to 0.5, the liver is either completely free of fibrosis (F0), or has a tiny bit of scarring (F1 or F2 by METAVIR Score). If the score is 1.5 or greater, the liver has scarring and likely some cirrhosis (F3 or F4 by METAVIR Score)

    3 months

  • Serum hyaluronic acid level

    Hyaluronic acid is a chief component of the extracellular matrix (ECM) of connective tissues and The most important organ involved in the synthesis of hyaluronic acid is the liver

    3 months

Study Arms (2)

Group 2

ACTIVE COMPARATOR

25 patients will receive 50mg Zinc Sulphate plus the standard direct acting anti-viral therapy for 3 months.

Drug: Zinc Supplement

Group 1

NO INTERVENTION

25 patients will receive their standard direct acting anti-viral therapy for 3 months

Interventions

Zinc SupplementDRUG

Zinc sulphate 50 mg

Group 2

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with fibrosis stage (F1\&F2) post chronic HCV infection.
  • 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 HBV.
  • Patients with any malignancies.
  • Pregnant and lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Liver Institute

Shibīn al Kawm, Egypt

Location

Related Publications (1)

  • El-Haggar SM, Attalla DS, Elhelbawy M, El-Afify DR. A randomized clinical study to evaluate the possible antifibrotic effect of zinc sulfate in chronic HCV patient receiving direct-acting anti-viral therapy. Inflammopharmacology. 2025 Jan;33(1):329-339. doi: 10.1007/s10787-024-01628-3. Epub 2025 Jan 9.

    PMID: 39789197DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 19, 2022

Study Start

August 1, 2022

Primary Completion

January 1, 2023

Study Completion

August 30, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)