Hepatitis C, ChronicNCT01945008
Observational Study in HCV Chronic Infection
An observational study of Hepatitis C, Chronic, run by Istituto Superiore di Sanità at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 7,600 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- All HCV infected patients who will consecutively come to the participating clinical centers in a given time span (enrollment periods)
Who cannot join
- Younger than 18 years
- Patients treated at the moment of the enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Hepatitis C, Chronic
- Keywords
- HCV, observational study, HCV direct-acting antiviral agents
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis-C infected patients | Patients with Hepatitis-C infection untreated at the enrolment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age distribution at recruitment
Age distribution will be expressed in years and reported as median
Measured: ten years
Sex distribution at recruitment
The sex distribution (males and females) will be reported as frequencies (percent)
Measured: ten years
BMI distribution at recruitment
The BMI (kg/m^2) will be expressed in the following cathegories: Underweight, Normal, Overweight, Obese and will be reported as frequencies (percent)
Measured: ten years
Genotype distribution at recruitment
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)
Measured: ten years
Liver disease stage at recruitment
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)
Measured: ten years
Sustained virological response (SVR) in treated patients
Rates of SVR for each expected combination of DAAs used; identification of factors influencing HCV treatment response in the real life.
Measured: ten years
Changes in the severity of liver disease
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)
Measured: ten years
Incidence of Hepatocellular carcinoma (HCC)
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)
Measured: ten years
Incidence and recurrence of decompensated cirrhosis
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)
Measured: ten years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startApr 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Superiore di Sanità
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefano Vella, Istituto Superiore di Sanità
- Investigators
- Loreta Kondili, MD, Principal investigator, Istituto Superiore di Sanità
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945008
- Sponsor's protocol ID
- PITER 01
- Status last verified
- Apr 2020
- First submitted
- 13 Sep 2013
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicentric Observational Study in HCV Chronic Infected Patients.
- ClinicalTrials.gov ID
- NCT01945008
- Acronym / sponsor ID
- PITER 01
- Conditions
- Hepatitis C, Chronic
- Keywords
- HCV, observational study, HCV direct-acting antiviral agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,600 participants (actual)
- Lead sponsor
- Istituto Superiore di SanitàUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis-C infected patients | – | –Patients with Hepatitis-C infection untreated at the enrolment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- All HCV infected patients who will consecutively come to the participating clinical centers in a given time span (enrollment periods)
Key exclusion criteria (2 listed)
- Younger than 18 years
- Patients treated at the moment of the enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age distribution at recruitment
Time frame: ten years
Age distribution will be expressed in years and reported as median
Sex distribution at recruitment
Time frame: ten years
The sex distribution (males and females) will be reported as frequencies (percent)
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)
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)
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)
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.
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreta Kondili, MD principal investigator
Istituto Superiore di Sanità
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Istituto Superiore di Sanità at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age distribution at recruitment (time frame: ten years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.