- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03646396
Effect of Sofosbuvir-daclatasuvir on Angiogenesis
August 23, 2018 updated by: Sherief Abd-Elsalam
Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection
The study aimed at study of the Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection
Study Overview
Detailed Description
The study primary aim was at evaluation of the Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
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
- Recruiting
- Sherief Abd-Elsalam
-
-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic HCV patients
Exclusion Criteria:
- HCC.
- HIV or HBV.
- Malignancy.
- Pregnancy.
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sofosbuvir-daclatasvir
Sofosbuvir-daclatasvir for 3 months
|
Sofosbuvir-daclatasvir for 3 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with change in VEGF, TGFB1
Time Frame: 6 months
|
Number of patients with change in VEGF, TGFB1
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eman h abd El-Razek, Msc, Clinical pharmacy Department- Tanta University
- Principal Investigator: Tarek M Mostafa, Ph D, Clinical pharmacy Department- Tanta University
- Principal Investigator: Nashwa Shebl, Ph D, Hematology and Gastroenterology - Menoufia University
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)
August 1, 2018
Primary Completion (Anticipated)
August 1, 2025
Study Completion (Anticipated)
December 1, 2025
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
August 23, 2018
First Posted (Actual)
August 24, 2018
Study Record Updates
Last Update Posted (Actual)
August 24, 2018
Last Update Submitted That Met QC Criteria
August 23, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sofosbuvir angiogenesis
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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