Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Observational Study in HCV Chronic Infection

14 april 2020 bijgewerkt door: Stefano Vella, Istituto Superiore di Sanità

Prospective Multicentric Observational Study in HCV Chronic Infected Patients.

HCV infection is the most frequent cause of liver chronic disease, cirrhosis and hepatocellular carcinoma in western countries.

To date, the standard antiviral treatment, including pegylated interferon (PEG-IFN) plus ribavirin (RBV), has relatively low effectiveness in patients infected with genotype 1 and 4, and is associated with important adverse side effects, that lead to treatment interruption in approximately 30% of cases.

The recent association of first generation HCV- specific direct-acting antiviral agents (DAAs) (telaprevir and boceprevir) to standard treatment has resulted in higher SVR rates, also in patients infected with genotype-1 HCV and in non responders to PEG-IFN plus RBV. While several new DAAs are in development, the ultimate goal is represented by IFN-free regimens, that will provide a great advantage in terms of patients adherence to therapy and quality of life.

In this context, prospective observational studies are needed to evaluate the real and long-term impact of the new DAAs in the clinical practice, in terms of efficacy, safety, costs and impact on patients quality of life.

Italy is the European country with the greatest number of HCV infected people (average, 3% of population), with higher prevalence in the center and in the south of the country, especially in older individuals, and the highest mortality caused by hepatocellular carcinoma. Genotype 1 is the most frequent one (in more than 50% of infected people). DAAs were approved at the end of 2012. For these reasons, Italy represents an interesting context for collecting data on long-term efficacy, safety and tolerability of new anti-HCV treatments.

The PITER cohort study, developed in the frame of Italian Platform for the study of the therapy of viral hepatitis a prospective observational study, is based on a large cohort of HCV infected patients from more than 100 clinical centers distributed on the whole national area.

The main aims of the PITER longitudinal cohort study are: 1) to produce of an ongoing and continuously updated picture of the changing epidemiology of HCV infection in the country; 2) to evaluate in a real-life setting the expected impact of DAAs on the natural course of infection and on long-term morbidity and mortality.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

Collected data will include clinical, laboratory and anatomopathological information and will be recorded in electronic CRF, at the enrollment and follow-up visits.

Special attention will be devoted to specific patient categories (with HIV, HBV, HDV and HEV coinfections, comorbidities, disease patients who presents signs of liver disease progression). Subjects starting an antiviral regimen will be followed according to specific guidelines.

A sub-study on quality of life/adherence to treatment/treatment satisfaction will be also conducted on all treated patients of the cohort.

Studietype

Observationeel

Inschrijving (Werkelijk)

7600

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
      • Rome, Italië, 00161
        • Istituto Superiore di Sanità

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Patient characteristics: :

  • any clinical and histopathologic stage of HCV infection
  • infected by any HCV genotypes
  • Untreated at the time of the enrolment (previously treated subjects are eligible)
  • With/without HBV co-infection
  • With/without HIV co-infection (in any clinical stage of HIV infection, with or without antiretroviral treatment)

Beschrijving

Inclusion Criteria:

- All HCV infected patients who will consecutively come to the participating clinical centers in a given time span (enrollment periods)

Exclusion Criteria:

  • Younger than 18 years
  • Patients treated at the moment of the enrollment

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Cohorten en interventies

Groep / Cohort
Hepatitis-C infected patients
Patients with Hepatitis-C infection untreated at the enrolment

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Age distribution at recruitment
Tijdsspanne: ten years
Age distribution will be expressed in years and reported as median
ten years
Sex distribution at recruitment
Tijdsspanne: ten years
The sex distribution (males and females) will be reported as frequencies (percent)
ten years
BMI distribution at recruitment
Tijdsspanne: ten years
The BMI (kg/m^2) will be expressed in the following cathegories: Underweight, Normal, Overweight, Obese and will be reported as frequencies (percent)
ten years
Genotype distribution at recruitment
Tijdsspanne: ten years
Genotype distribution will be expressed in the following categories: 1 non subtyped, 1a, 1b, 2, 3, 4-5, and will be reported as frequencies (percent)
ten years
Liver disease stage at recruitment
Tijdsspanne: ten years
The liver disease stage distribution will be expressed in the following chategories: F0-F3, F4-cirrhosis, decompensated cirrhosis, HCC, liver transplant, and will be reported as frequencies (percent)
ten years
Sustained virological response (SVR) in treated patients
Tijdsspanne: ten years
Rates of SVR for each expected combination of DAAs used; identification of factors influencing HCV treatment response in the real life.
ten years
Changes in the severity of liver disease
Tijdsspanne: ten years

Changes in liver function will be evaluated in terms of Child Pugh (C-P) score increase or decrease by 1 or more points, whatever occurred first after the end of treatment.

This outcome will be expressed as proportions (percent)
ten years
Incidence of Hepatocellular carcinoma (HCC)
Tijdsspanne: ten years

Incidence of HCC will be evaluated on the basis of the first diagnosis reported after the end of treatment, excluding prevalent HCC cases occurred before treatment.

Cumulative incidence will be expressed as proportions (percent)
ten years
Incidence and recurrence of decompensated cirrhosis
Tijdsspanne: ten years

Liver decompensating event is defined as the presence or appearance of ascites and/or portal hypertensive gastrointestinal bleeding and/or hepatic encephalopathy.

Incidence of a decompensating event will be evaluated on the basis of the first occurrence after the end of treatment, excluding cases occurred before treatment.

Recurrence of decompensation will be evaluated on the basis of the first events in patients with previous history of decompensated cirrhosis.

Cumulative incidence or recurrence will be expressed as proportions (percent)
ten years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istituto Superiore di Sanità

Onderzoekers

  • Hoofdonderzoeker: Loreta Kondili, MD, Istituto Superiore di Sanità

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2014

Primaire voltooiing (Werkelijk)

1 november 2015

Studie voltooiing (Werkelijk)

1 november 2015

Studieregistratiedata

Eerst ingediend

13 september 2013

Eerst ingediend dat voldeed aan de QC-criteria

13 september 2013

Eerst geplaatst (Schatting)

18 september 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 april 2020

Laatste update ingediend die voldeed aan QC-criteria

14 april 2020

Laatst geverifieerd

1 april 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PITER 01

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Hepatitis C, chronisch

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Papua New Guinea

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren