- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770936
Effect of Some Drugs on Liver Fibrosis
December 7, 2018 updated by: Sherief Abd-Elsalam
Clinical Study Evaluating the Efficacy of Renin Angiotensin System Inhibitors on the Extent of Liver Fibrosis in Patients With Chronic Hepatitis C
Effect of Some Drugs on Liver Fibrosis
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study aimed at evaluating the effect of Some Drugs on Liver Fibrosis
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tanta, Egypt, 35111
- Recruiting
- Sherief Abd-Elsalam
-
Contact:
- Abeer Abd-Almohsen, Msc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- chronic hepatitis C
Exclusion Criteria:
- Acute hepatitis
- Thalassemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
No intervention
|
|
Active Comparator: Candesartan
Candesartan 8 mg/day
|
Candesartan 8 mg/day
Other Names:
|
Active Comparator: Ramipril
Ramipril 1.25 mg/day
|
ramipril 1.25 mg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fibroscan or APRI score
Time Frame: 6 months
|
Change in Fibroscan or APRI score
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gamal El-azab, Prof, Clinical pharmacy Department- Tanta University
- Study Director: Tarek Mostafa, Prof, Cardiology Department- Tanta University
- Study Chair: Gamal Badra, Prof, National Hepatology Institute - Egypt
- Study Chair: Abeer El-Motwally, Msc, Clinical pharmacy Department-Tanta University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Anticipated)
October 1, 2026
Study Completion (Anticipated)
November 1, 2027
Study Registration Dates
First Submitted
December 7, 2018
First Submitted That Met QC Criteria
December 7, 2018
First Posted (Actual)
December 10, 2018
Study Record Updates
Last Update Posted (Actual)
December 10, 2018
Last Update Submitted That Met QC Criteria
December 7, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Liver Diseases
- Fibrosis
- Liver Cirrhosis
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Enzyme Inhibitors
- Protease Inhibitors
- Angiotensin II Type 1 Receptor Blockers
- Angiotensin Receptor Antagonists
- Angiotensin-Converting Enzyme Inhibitors
- Candesartan
- Ramipril
Other Study ID Numbers
- liver fibrosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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