NCT03770936

Brief Summary

Effect of Some Drugs on Liver Fibrosis

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for phase_3

Timeline
18mo left

Started Oct 2018

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
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 Progress84%
Oct 2018Nov 2027

Study Start

First participant enrolled

October 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

December 10, 2018

Status Verified

December 1, 2018

Enrollment Period

8 years

First QC Date

December 7, 2018

Last Update Submit

December 7, 2018

Conditions

Liver Fibroses

Outcome Measures

Primary Outcomes (1)

  • Change in Fibroscan or APRI score

    Change in Fibroscan or APRI score

    6 months

Study Arms (3)

Control group

NO INTERVENTION

No intervention

Candesartan

ACTIVE COMPARATOR

Candesartan 8 mg/day

Drug: Candesartan

Ramipril

ACTIVE COMPARATOR

Ramipril 1.25 mg/day

Drug: Ramipril

Interventions

CandesartanDRUG

Candesartan 8 mg/day

Also known as: Cansartan
Candesartan
RamiprilDRUG

ramipril 1.25 mg/day

Ramipril

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic hepatitis C

You may not qualify if:

  • Acute hepatitis
  • Thalassemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, 35111, Egypt

RECRUITING

Related Publications (1)

  • Mostafa TM, El-Azab GA, Badra GA, Abdelwahed AS, Elsayed AA. Effect of Candesartan and Ramipril on Liver Fibrosis in Patients with Chronic Hepatitis C Viral Infection: A Randomized Controlled Prospective Study. Curr Ther Res Clin Exp. 2021 Nov 12;95:100654. doi: 10.1016/j.curtheres.2021.100654. eCollection 2021.

    PMID: 34925649DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

candesartanRamipril

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gamal El-azab, Prof

    Clinical pharmacy Department- Tanta University

    PRINCIPAL INVESTIGATOR

  • Tarek Mostafa, Prof

    Cardiology Department- Tanta University

    STUDY DIRECTOR

  • Gamal Badra, Prof

    National Hepatology Institute - Egypt

    STUDY CHAIR

  • Abeer El-Motwally, Msc

    Clinical pharmacy Department-Tanta University

    STUDY CHAIR

Central Study Contacts

Sherief Abd-Elsalam, Ph D

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ass. Prof. Tropical Medicine

Study Record Dates

First Submitted

December 7, 2018

First Posted

December 10, 2018

Study Start

October 1, 2018

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

December 10, 2018

Record last verified: 2018-12

Locations

EG(1)