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Effect of Sofosbuvir-daclatasuvir on Angiogenesis

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ClinicalTrials.gov Identifier: NCT03646396
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Sherief Abd-Elsalam, Tanta University

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
HCV Coinfection Drug: Sofosbuvir-daclatasvir Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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 : August 1, 2018
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sofosbuvir-daclatasvir
Sofosbuvir-daclatasvir for 3 months
Drug: Sofosbuvir-daclatasvir
Sofosbuvir-daclatasvir for 3 months
Other Name: sof-dakla




Primary Outcome Measures :
  1. Number of patients with change in VEGF, TGFB1 [ Time Frame: 6 months ]
    Number of patients with change in VEGF, TGFB1



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic HCV patients

Exclusion Criteria:

  • HCC.
  • HIV or HBV.
  • Malignancy.
  • Pregnancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646396


Contacts
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Contact: Sherief Abd-Elsalam, MD 00201147773440 sheriefabdelsalam@yahoo.com

Locations
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Egypt
Sherief Abd-Elsalam Recruiting
Tanta, Egypt
Contact: Sherief Abd-elsalam, lecturer    00201000040794    Sherif_tropical@yahoo.com   
Sponsors and Collaborators
Sherief Abd-Elsalam
Investigators
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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

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Responsible Party: Sherief Abd-Elsalam, PhDTropical Medicine, Tanta University
ClinicalTrials.gov Identifier: NCT03646396     History of Changes
Other Study ID Numbers: sofosbuvir angiogenesis
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Coinfection
Infection
Virus Diseases
Parasitic Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents