Chronic Hepatitis C in Chronic Hemodialysis Recipients - An Observational Study

NCT03461250 | Unknown

• 1 other identifier: AsociacionPEH
• Study Type: observational
• Target: 293
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational study of cases of chronic hepatitis C and negative HCV controls in adults receiving chronic hemodialysis at the National Renal Health Center (NRHC) -EsSalud in Lima - Peru.The NRHC provides specialized health care, including hemodialysis, to people with advanced kidney disease from all the districts of Lima. Study population: By December 2017, there were 293 adults receiving chronic hemodialysis at the NRHC-EsSalud. All adult patients receiving chronic hemodialysis at the NRHC-EsSalud will be invited to participate. Primary objective: Characterize HCV disease in patients receiving chronic hemodialysis at the NRHC-EsSalud. Secondary objective: Identify factors associated with an increased risk of HCV infection. Inclusion criteria: Age \> 18 years Receive chronic hemodialysis (for at least 6 consecutive months) at the NRHC. Exclusion criteria: • Inability to provide informed consent. To comply with the primary objective of the study, samples from volunteers with HCV serology confirmed in Roe Clinic Laboratory (cases) will be subjected to additional tests: HCV viral load followed by determination of the HCV genotype by using the Abbott m2000 real-time PCR system capable of identifying genotypes 1 (1a and 1b), 2, 3, 4 , 5 and 6, using fluorescent probes of oligonucleotides specific for each genotype . In addition to these lab tests, volunteers will have a Fibroscan test performed at a local provider, with the Fibroscan Model 402 with E and XL probes. The information will be collected in a Case Report Form (CRF), which will be filled out by study staff. The source of clinical information will be primarily the clinical history of the NRHC - EsSalud. The source of information on the results of the auxiliary tests will be obtained from the results issued by Roe Clinic Laboratory and by the image center of the Delgado Clínic. Protection of Human Subjects: The protocol and informed consent will be reviewed and approved by the Ethics Committee of the NRHC. No study procedure will be carried out if the volunteer has not given his or her written consent. All reasonable precautions will be taken to protect the privacy of the volunteer's information, whose data will be identified only through a code. Researchers will keep the study folders in a locked cabinet in a safe place

Conditions

HCV Infection

Keywords

HCV infection; hemodialysis; HCV genotype; Liver Fibrosis stage

Outcome Measures

Primary Outcomes (1)

• Characterize HCV disease in patients with chronic hemodialysis at the NRHC-EsSalud

  Determine risk factors HCV infection with CRF and clinical charts review, level of viral load and HCV genotype and liver stage fibrosis by Fibroscan.

  6 months

Study Arms (2)

HCV serology negative in HD

Risk factors

Diagnostic Test: HCV serology

HCV serology positive in HD

Risk factors HCV viral load HCV genotype Liver elastography by Fibroscan

Diagnostic Test: HCV serology

Interventions

HCV serology DIAGNOSTIC_TEST

Apply CRF to identify risk factors for HCV infection. In patients with positive HCV serology measure the level of viral load and HCV genotype by PCR Abbott-real time and determine the stage of liver fibrosis by elastography (Fibroscan)

Also known as: HCV viral load, HCV genotype, Liver fibrosis stage by Fibroscan

HCV serology negative in HD; HCV serology positive in HD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on chronic hemodialysis for at least 6 consecutive months at the NRHC. EsSalud. Lima. Peru.

You may qualify if:

• Age: \> 18 years
• Receive chronic hemodialysis (for at least 6 consecutive months) at the NRHC. EsSalud

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• Asociacion para el Estudio del Higado: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (8)

• Ly KN, Xing J, Klevens RM, Jiles RB, Ward JW, Holmberg SD. The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012 Feb 21;156(4):271-8. doi: 10.7326/0003-4819-156-4-201202210-00004.

  PMID: 22351712 BACKGROUND

• Marcellin P. Hepatitis C: the clinical spectrum of the disease. J Hepatol. 1999;31 Suppl 1:9-16. doi: 10.1016/s0168-8278(99)80368-7.

  PMID: 10622554 BACKGROUND

• Cacoub P, Comarmond C, Domont F, Savey L, Desbois AC, Saadoun D. Extrahepatic manifestations of chronic hepatitis C virus infection. Ther Adv Infect Dis. 2016 Feb;3(1):3-14. doi: 10.1177/2049936115585942.

  PMID: 26862398 BACKGROUND

• Sanchez JL, Sjogren MH, Callahan JD, Watts DM, Lucas C, Abdel-Hamid M, Constantine NT, Hyams KC, Hinostroza S, Figueroa-Barrios R, Cuthie JC. Hepatitis C in Peru: risk factors for infection, potential iatrogenic transmission, and genotype distribution. Am J Trop Med Hyg. 2000 Nov-Dec;63(5-6):242-8.

  PMID: 11421371 BACKGROUND

• Mendez Chacon P, Vidalon A, Vildosola H. [Risk factors for hepatitis C in hemodialysis and its impact on the waiting list for kidney transplantation]. Rev Gastroenterol Peru. 2005 Jan-Mar;25(1):12-8. Spanish.

  PMID: 15818418 BACKGROUND

• Fabrizi F, Messa P. Therapy of hepatitis C by direct-acting anti-virals: the end of HCV in dialysis population? Expert Rev Clin Pharmacol. 2015;8(6):785-93. doi: 10.1586/17512433.2015.1086266. Epub 2015 Sep 12.

  PMID: 26365524 BACKGROUND

• National Kidney Foundation. K/DOQI clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Am J Kidney Dis. 2002 Feb;39(2 Suppl 1):S1-266. No abstract available.

  PMID: 11904577 BACKGROUND

• Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. doi: 10.1111/j.1523-1755.2005.00365.x.

  PMID: 15882252 BACKGROUND

Related Links

• HCV epidemiology

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• P.Martin Padilla, MD

  Asociacion para el Estudio del Higado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rocio Ramos, MD

CONTACT

51 942941392; secretariaapeh@gmail.com

Rocio Galloso, MD

CONTACT

51 999961942; secretariaapeh@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 12, 2018
• Study Start: April 1, 2018
• Primary Completion: June 30, 2018
• Study Completion: August 30, 2018
• Last Updated: April 3, 2018

Record last verified: 2018-03