The Renal Safety in Patients With Chronic HCV Undergoing Sofosbuvir Containing Antiviral Therapy

NCT04169464 | Unknown Phase 4

• 1 other identifier: ID22218
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the occurrence of AKI during antiviral therapy, when compared with baseline values in Egyptian patients. In addition, the study aims to evaluate the change in insulin resistance value after treating patients from HCV.

Conditions

Egyptian Patients, HCV Treatment, Kidney Function

Keywords

HCV; DAAs; Egyptian patients; creatinine; insulin resistence; GFR

Outcome Measures

Primary Outcomes (1)

• occurance of AKI during therapy

  investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (eGFR) when compared with baseline eGFR in Egyptian patients.

  3 months

Study Arms (1)

group I

OTHER

A group of HCV infected patients treated with DAA therapy including Sofospovir

Drug: Sofosbuvir Oral Product

Interventions

Sofosbuvir Oral Product DRUG

to investigate the drug effect on renal function and insulin resistance

group I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥ 18 years Chronic infection with HCV GT 4 No prior HCV treatment experience

You may not qualify if:

• Co-infection with HBV or HIV, clinical evidence of ischemic heart disease, the presence of diabetic ketoacidosis, Patients admitted to the intensive care unit (ICU), or expected to undergo surgery during the study period, and Child Pough score C.

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Thabet Thabet hospital

Cairo, 11311, Egypt

Location

Study Officials

• Dalia Zaafar, Phd

  Lecturer of pharmacology and toxicology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pharmacology and Toxicology

Study Record Dates

• First Submitted: November 17, 2019
• First Posted: November 19, 2019
• Study Start: April 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)