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

NCT03965286 | Unknown

• 1 other identifier: DAAs on eGFR
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.evaluation of glomerular filtration rate(eGFR)changes during HCV treatment with direct antiviral drugs according to 2018 guideline.
2. 2.TO estimate the frequency of renal impairment by direct antiviral drugs By detection of any changes in e GFR.
3. 3.Assessment The Renal safety during HCV treatment with direct antiviral drugs according to 2018 guideline.
4. 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.

Conditions

Antiviral Drug

Outcome Measures

Primary Outcomes (1)

• glomerular filtration rate(eGFR) changes during HCV treatment

  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)

  3 month

Secondary Outcomes (1)

• Effect of direct anti Viral drugs on kidney function

  3 month

Study Arms (1)

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

Interventions

DAAs DRUG

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

Also known as: ledipasvir/sofosbuvir/daclatasvir

Patients with chronic HCV will be on direct antiviral drugs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Brown PR, Sadiq O, Weick A, Lenhart A, Elbatta M, Fernandez C, Kutait A, Pompa R, Jafri SM. Acute Kidney Injury in Patients Undergoing Chronic Hepatitis C Virus Treatment With Ledipasvir/Sofosbuvir. Hepatol Commun. 2018 Sep 24;2(10):1172-1178. doi: 10.1002/hep4.1243. eCollection 2018 Oct.

  PMID: 30288472 BACKGROUND

• Soeiro CASP, Goncalves CAM, Marques MSC, Mendez MJV, Tavares APRA, Horta AMLMFCA, Sarmento-Castro RMDR. Glomerular filtration rate change during chronic hepatitis C treatment with Sofosbuvir/Ledipasvir in HCV/HIV Coinfected patients treated with Tenofovir and a boosted protease inhibitor: an observational prospective study. BMC Infect Dis. 2018 Aug 3;18(1):364. doi: 10.1186/s12879-018-3278-3.

  PMID: 30075765 BACKGROUND

• Shah H, Bilodeau M, Burak KW, Cooper C, Klein M, Ramji A, Smyth D, Feld JJ; Canadian Association for the Study of the Liver. The management of chronic hepatitis C: 2018 guideline update from the Canadian Association for the Study of the Liver. CMAJ. 2018 Jun 4;190(22):E677-E687. doi: 10.1503/cmaj.170453. No abstract available.

  PMID: 29866893 BACKGROUND

MeSH Terms

Interventions

ledipasvir

Study Officials

• Enas Alkareemy, MD

  Assuit university hospital

  STUDY DIRECTOR

Central Study Contacts

Moamen Mohey

CONTACT

01091094556; momen_mohey880@yahoo.com

Samir Kmal

CONTACT

samirkamal@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 29, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: May 29, 2019

Record last verified: 2019-05