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Effect of Sofosbuvir-daclatasuvir on Angiogenesis

Sponsor
Sherief Abd-Elsalam (Other)
Overall Status
Recruiting
CT.gov ID
NCT03646396
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
88
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Drug "sof-Dakla"Drug "sof-Dakla"
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sofosbuvir-daclatasvir

Sofosbuvir-daclatasvir for 3 months

Drug: Sofosbuvir-daclatasvir
Sofosbuvir-daclatasvir for 3 months
Other Names:
  • sof-dakla

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with change in VEGF, TGFB1 [6 months]

      Number of patients with change in VEGF, TGFB1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chronic HCV patients
    Exclusion Criteria:

    • HCC.

    • HIV or HBV.

    • Malignancy.

    • Pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sherief Abd-Elsalam Tanta Egypt

    Sponsors and Collaborators

    • Sherief Abd-Elsalam

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
    ClinicalTrials.gov Identifier:
    NCT03646396
    Other Study ID Numbers:
    • sofosbuvir angiogenesis
    First Posted:
    Aug 24, 2018
    Last Update Posted:
    Aug 24, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Coinfection
    Sofosbuvir

    Study Results

    No Results Posted as of Aug 24, 2018