NCT03646396

Brief Summary

The study aimed at study of the Effect of Daclatasvir Plus Sofosbuvir on Angiogenesis in Egyptian Patients With Chronic HCV Infection

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

7 years

First QC Date

August 23, 2018

Last Update Submit

August 23, 2018

Conditions

HCV Coinfection

Outcome Measures

Primary Outcomes (1)

  • Number of patients with change in VEGF, TGFB1

    Number of patients with change in VEGF, TGFB1

    6 months

Study Arms (1)

Sofosbuvir-daclatasvir

EXPERIMENTAL

Sofosbuvir-daclatasvir for 3 months

Drug: Sofosbuvir-daclatasvir

Interventions

Sofosbuvir-daclatasvirDRUG

Sofosbuvir-daclatasvir for 3 months

Also known as: sof-dakla
Sofosbuvir-daclatasvir

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic HCV patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherief Abd-Elsalam

Tanta, Egypt

RECRUITING

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Drug "sof-Dakla"
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhDTropical Medicine

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

EG(1)