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Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital

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ClinicalTrials.gov Identifier: NCT03965286
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Moamen mohey AbdElhamid, Assiut University

Brief Summary:
  1. evaluation of glomerular filtration rate(eGFR)changes during HCV treatment with direct antiviral drugs according to 2018 guideline.
  2. TO estimate the frequency of renal impairment by direct antiviral drugs By detection of any changes in e GFR.
  3. Assessment The Renal safety during HCV treatment with direct antiviral drugs according to 2018 guideline.
  4. To clarify the importance of laboratory and other modalities in detection and estimation of frequency of renal impairment by direct antiviral drugs according to 2018 guideline.

Condition or disease Intervention/treatment
Antiviral Drug Drug: DAAs

Detailed Description:

Hepatitis C virus (HCV) has an estimated global prevalence of 2%-3% with 130-170 million people infected with HCV.(1) HCVcauses chronic inflammation of the liver leading to chronic hepatitis, which can advance to liver cirrhosis and hepatocellular carcinoma and significant extrahepatic complications.(2) Additionally, HCV has been shown to have a significant negative effect on apatient's overall quality of life, including decreased work hours and productivity and increased healthcare costs.(3) Cirrhosis and hepatocellular carcinoma related to HCV infection represent the most common indications for liver transplantation duo to poor treatment options.(4) Until recently, interferon-based treatments were thebackbone of HCV treatment options.(5) Unfortunately,therapy was only modestly effective and associatedwith significant side effects.(6) Therefore, research has focused on HCV eradication using oral antiviral therapy.

Recent clinical studies have demonstrated efficacy using the nucleotide analogue inhibitor sofosbuvir(Sovaldi; Gilead Sciences, Inc., Foster City, CA) as the backbone in treatment of non transplant and post transplant recurrent HCV.(7) Both the ION-1 and ION-2 trials demonstrated nearly 99% efficacy in the treatment ofnontransplant, noncirrhotic HCV patientsusing sofosbuvir in a fixed-dose combination with theNS5A inhibitor ledipasvir (Harvoni, Gilead Sciences,Inc.), both with and without ribavirin.(8,9) The side effect profile of ledipasvir/sofosbuvir (LDV/SOF) hasbeen relatively mild and the drug has been well tolerated in trials, especially compared with previous interferon-based regimens.

The ION trials report that LDV/SOF therapy was primarily complicated by headaches or fatigue inapproximately 10% of patients. Less frequently, patients experienced rashes, nausea, diarrhea, and insomnia.Serious side effects, such as nephrotoxicity, were not demonstrated by the ION-1 and ION-2 trials; however, these trials were conducted in a controlled clinical setting with rigorous exclusion criteria. Such trials are not always entirely reflective of the general patient population. Early data suggest possible risk of renal impairment during treatment with the use of direct antiviral drugs(10) this study is about renal safety and changes in eGFR in patients with chronic HCV undergoing direct acting antiviral therapy according to 2018 guideline.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Direct AntiViral Drugs of Chronic HCV on eGFR in Assuit Universiry Hospital
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Group/Cohort Intervention/treatment
Patients with chronic HCV will be on direct antiviral drugs
is defined as the presence of detectable viral replication for at least six months diagnosed by quantitative HCV RNA polymerase chain reaction (PCR)
Drug: DAAs
Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 12 weeks Daily simeprevir (150 mg) plus sofosbuvir (400 mg) 12 weeks Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) 12 weeks Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with dasabuvir (600 mg) 12weeks
Other Name: ledipasvir/sofosbuvir/daclatasvir




Primary Outcome Measures :
  1. glomerular filtration rate(eGFR) changes during HCV treatment [ Time Frame: 3 month ]
    the frequency of renal impairment by evaluation of glomerular filtration rate(eGFR) changes during HCV treatment with direct antiviral drugs before and after the treatment using different equation for eGFR such as (MDRD, CKD_EPI,Cockroft)


Secondary Outcome Measures :
  1. Effect of direct anti Viral drugs on kidney function [ Time Frame: 3 month ]
    the frequency of renal impairment by direct antiviral drugs by measurement of serum BUN and creatinine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
chronic hepatitis C virus patients will be on direct antiviral therapy attending to the outpatient clinics and inpatient of gastroenterology units of Internal medicine department .
Criteria

Inclusion Criteria:

  • chronic hepatitis C virus patients will be on direct antiviral therapy .

Exclusion Criteria:

  • patients with DM ,HTN ,CKD,Autoimmune Diseases Patients with kidney injury other than DAAs Patients with sever heart failure or malignancy

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): NCT03965286


Contacts
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Contact: Moamen Mohey 01091094556 momen_mohey880@yahoo.com
Contact: Samir Kmal samirkamal@aun.edu.eg

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Enas Alkareemy, MD Assuit university hospital
Publications:
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Responsible Party: Moamen mohey AbdElhamid, Resident doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03965286    
Other Study ID Numbers: DAAs on eGFR
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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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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Sofosbuvir
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents