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Observational Study in HCV Chronic Infection

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ClinicalTrials.gov Identifier: NCT01945008
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : April 15, 2020
Information provided by (Responsible Party):
Stefano Vella, Istituto Superiore di Sanità

Brief Summary:

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.

Condition or disease
Hepatitis C, Chronic

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 7600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Multicentric Observational Study in HCV Chronic Infected Patients.
Study Start Date : April 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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

Primary Outcome Measures :
  1. Age distribution at recruitment [ Time Frame: ten years ]
    Age distribution will be expressed in years and reported as median

  2. Sex distribution at recruitment [ Time Frame: ten years ]
    The sex distribution (males and females) will be reported as frequencies (percent)

  3. BMI distribution at recruitment [ Time Frame: 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)

  4. Genotype distribution at recruitment [ Time Frame: 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)

  5. Liver disease stage at recruitment [ Time Frame: 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)

  6. Sustained virological response (SVR) in treated patients [ Time Frame: ten years ]
    Rates of SVR for each expected combination of DAAs used; identification of factors influencing HCV treatment response in the real life.

  7. Changes in the severity of liver disease [ Time Frame: 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)

  8. Incidence of Hepatocellular carcinoma (HCC) [ Time Frame: 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)

  9. Incidence and recurrence of decompensated cirrhosis [ Time Frame: 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)

Biospecimen Retention:   Samples With DNA
Blood samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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)

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

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): NCT01945008

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Istituto Superiore di Sanità
Rome, Italy, 00161
Sponsors and Collaborators
Istituto Superiore di Sanità
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Principal Investigator: Loreta Kondili, MD Istituto Superiore di Sanità
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Responsible Party: Stefano Vella, Director of the Department of Therapeutic Research and Medicines Evaluation, Istituto Superiore di Sanità
ClinicalTrials.gov Identifier: NCT01945008    
Other Study ID Numbers: PITER 01
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Keywords provided by Stefano Vella, Istituto Superiore di Sanità:
observational study
HCV direct-acting antiviral agents
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic