Back to resultsEffect of Some Drugs on Liver Fibrosis
Primary Purpose
Liver Fibroses
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Candesartan
Ramipril
Sponsored by
About this trial
This is an interventional treatment trial for Liver Fibroses
Eligibility Criteria
Inclusion Criteria:
- chronic hepatitis C
Exclusion Criteria:
- Acute hepatitis
- Thalassemia
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Control group
Candesartan
Ramipril
Arm Description
No intervention
Candesartan 8 mg/day
Ramipril 1.25 mg/day
Outcomes
Primary Outcome Measures
Change in Fibroscan or APRI score
Change in Fibroscan or APRI score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03770936
Brief Title
Effect of Some Drugs on Liver Fibrosis
Official Title
Clinical Study Evaluating the Efficacy of Renin Angiotensin System Inhibitors on the Extent of Liver Fibrosis in Patients With Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
November 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sherief Abd-Elsalam
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Effect of Some Drugs on Liver Fibrosis
Detailed Description
The study aimed at evaluating the effect of Some Drugs on Liver Fibrosis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibroses
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Candesartan
Arm Type
Active Comparator
Arm Description
Candesartan 8 mg/day
Arm Title
Ramipril
Arm Type
Active Comparator
Arm Description
Ramipril 1.25 mg/day
Intervention Type
Drug
Intervention Name(s)
Candesartan
Other Intervention Name(s)
Cansartan
Intervention Description
Candesartan 8 mg/day
Intervention Type
Drug
Intervention Name(s)
Ramipril
Intervention Description
ramipril 1.25 mg/day
Primary Outcome Measure Information:
Title
Change in Fibroscan or APRI score
Description
Change in Fibroscan or APRI score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic hepatitis C
Exclusion Criteria:
Acute hepatitis
Thalassemia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, Ph D
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gamal El-azab, Prof
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Mostafa, Prof
Organizational Affiliation
Cardiology Department- Tanta University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gamal Badra, Prof
Organizational Affiliation
National Hepatology Institute - Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Abeer El-Motwally, Msc
Organizational Affiliation
Clinical pharmacy Department-Tanta University
Official's Role
Study Chair
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abeer Abd-Almohsen, Msc
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34925649
Citation
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.
Results Reference
derived
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Effect of Some Drugs on Liver Fibrosis
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