Back to resultsEffect of Sofosbuvir-daclatasuvir on Angiogenesis
Primary Purpose
HCV Coinfection
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sofosbuvir-daclatasvir
Sponsored by
About this trial
This is an interventional treatment trial for HCV Coinfection
Eligibility Criteria
Inclusion Criteria:
- Chronic HCV patients
Exclusion Criteria:
- HCC.
- HIV or HBV.
- Malignancy.
- Pregnancy.
Sites / Locations
- Sherief Abd-ElsalamRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sofosbuvir-daclatasvir
Arm Description
Sofosbuvir-daclatasvir for 3 months
Outcomes
Primary Outcome Measures
Number of patients with change in VEGF, TGFB1
Number of patients with change in VEGF, TGFB1
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03646396
Brief Title
Effect of Sofosbuvir-daclatasuvir on Angiogenesis
Official Title
Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (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
The study aimed at study of the Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Coinfection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Drug "sof-Dakla"
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sofosbuvir-daclatasvir
Arm Type
Experimental
Arm Description
Sofosbuvir-daclatasvir for 3 months
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir-daclatasvir
Other Intervention Name(s)
sof-dakla
Intervention Description
Sofosbuvir-daclatasvir for 3 months
Primary Outcome Measure Information:
Title
Number of patients with change in VEGF, TGFB1
Description
Number of patients with change in VEGF, TGFB1
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic HCV patients
Exclusion Criteria:
HCC.
HIV or HBV.
Malignancy.
Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, MD
Phone
00201147773440
Email
sheriefabdelsalam@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman h abd El-Razek, Msc
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek M Mostafa, Ph D
Organizational Affiliation
Clinical pharmacy Department- Tanta University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nashwa Shebl, Ph D
Organizational Affiliation
Hematology and Gastroenterology - Menoufia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sherief Abd-Elsalam
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-elsalam, lecturer
Phone
00201000040794
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effect of Sofosbuvir-daclatasuvir on Angiogenesis
We'll reach out to this number within 24 hrs