Hepatitis C, ChronicNCT03149289
Hepatitis C Virus Infection in Patients With Hemoglobinopathies
An observational study of Hepatitis C, Chronic and Hemoglobinopathies, run by Società Italiana Talassemie ed Emoglobinopatie.
Trial summary
Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection. Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Hemoglobinopathies
- What is being tested?
- Antiviral drugs
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 1 Feb 2017
- 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 with hemoglobinopathies with cronic hepatitis C
Who may be able to join
- Patients with hemoglobinopathies, chronic hepatitis due to HCV and the presence of fibrosis (defined as Fibroscan® stiffness ≥10 kPa) or a bioptic evaluation of cirrhosis (same ISHAK fibrosis score) determined within 6 months previously. Patients with extrahepatic manifestations of chronic hepatitis C virus infection (cryoglobulinemia with organ damage, B-lymphoproliferative disorders) were also included.
Who cannot join
- Patients with active cancer, including hepatocellular carcinoma, and pregnant or lactating females were excluded from the study
About this study
Official title: Treatment of Hepatitis C Virus Infection With Direct-acting Antiviral Drugs in Patients With Hemoglobinopathies
Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection. Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver complications. EASL and AASLD guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. However, data regarding the use of direct-acting antiviral drugs (DAAs) in this patient population are very few This large, observational study evaluated the safety and efficacy of standard therapy with DAAs in a large Italian cohort of with hemoglobinopathies, chronic HCV infection and advanced liver fibrosis.
Read the detailed description
Many patients with hemoglobinopathies have been infected with hepatitis C virus (HCV) through blood transfusion, mostly before screening of blood donors was introduced in 1992. The reported prevalence of anti-HCV-positive thalassemia patients varies between 4.4% in Turkey and 85.4% in Italy. HCV infection is associated with decompensated cirrhosis, hepatocellular carcinoma and other liver complications, especially if left untreated. Prevalence of cirrhosis in thalassemia patients up to 32% have been reported.
Thalassemia patients with cirrhosis have an increased risk of death. Progression of liver fibrosis is strongly related to the presence of chronic HCV infection and extent of iron overload. Thalassemia patients with elevated serum aminotransferase levels for >6 months should be tested for HCV infection and, in the event of HCV infection, HCV genotyping is recommended in order to plan antiviral therapy and the likelihood of response. Noninvasive transient elastography (FibroScan®) can be used to determine the presence of fibrosis in thalassemia patients with HCV infection.
Effective chelation therapy and treatment of HCV infection are needed in order to prevent liver complications and decrease morbidity and mortality. For many years, pegylated interferon (peg-IFN) plus ribavirin was the standard of care for the treatment of chronic HCV infection and decompensated cirrhosis. Studies of peg-IFN plus ribavirin have demonstrated sustained virological response (SVR) rates of 25-64% in patients with thalassemia and HCV infection. However, peg-IFN and ribavirin are both associated with anemia. Ribavirin-associated hemolysis leads to an increased requirement for blood transfusions, which in turn can lead to worsening of iron overload. Therefore, European Association for the Study of the Liver (EASL) 2015 guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. The aim of this study was to evaluate the safety and efficacy of DAA standard regimens in patients with hemoglobinopathies and chronic HCV liver disease treated in Italy.
Antiviral treatments were administered according to Italian Medicines Agency (AIFA) guidelines.
- Conditions
- Hepatitis C, Chronic, Hemoglobinopathies
- Being tested
- Antiviral drugs
- Medical subject headings
- Hepatitis C, Chronic, Hemoglobinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiviral drugsDrug
Also called Direct-acting antiviral drugs'
sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir
| Study group | Role | What they receive |
|---|---|---|
| HCV RNA positive | hemoglobinopathies with hepatites C treated with antiviral drugs Receives: Drug: Antiviral drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of participants with undetectable serum HCV RNA is being assessed at the end of treatment
The quantification of hepatitis virus particles in serum is assessed and expressed in IU/mL (IU, international units ) through quantitation of virus ribonucleic acid by real time polymerase chain reaction (PCR).
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Mar 2015
- Primary completion1 Mar 2016
- Study completion1 Feb 2017
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
- Retrospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Società Italiana Talassemie ed Emoglobinopatie
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cagliari, University of Turin, Italy, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ente Ospedaliero Ospedali Galliera, University of Campania Luigi Vanvitelli, Cardarelli Hospital, Reggio Calabria, University of Palermo
- Responsible party
- Sponsor
- Investigators
- Vito Di Marco, MD, Study director, University of Palermo, Palermo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149289
- Sponsor's protocol ID
- HCV-SITE
- Status last verified
- Jan 2017
- First submitted
- 14 Apr 2017
- Last updated
- 11 May 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Hepatitis C Virus Infection With Direct-acting Antiviral Drugs in Patients With Hemoglobinopathies
- ClinicalTrials.gov ID
- NCT03149289
- Acronym / sponsor ID
- HCV-SITE
- Conditions
- Hepatitis C, Chronic, Hemoglobinopathies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Società Italiana Talassemie ed EmoglobinopatieUniversity, hospital or other
- Collaborators
- University of Cagliari, University of Turin, Italy, Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ente Ospedaliero Ospedali Galliera, University of Campania Luigi Vanvitelli, Cardarelli Hospital, Reggio Calabria, University of Palermo
- Study start
- 1 Mar 2015
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 11 May 2017 (actual)
- 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.
Progression of liver fibrosis in patients with hemoglobinopathies is strongly related to the severity of iron overload and the presence of chronic hepatitis C virus (HCV) infection. Effective iron chelation therapy and HCV infection eradication are efficacy to prevent liver complications. EASL and AASLD guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. However, data regarding the use of direct-acting antiviral drugs (DAAs) in this patient population are very few This large, observational study evaluated the safety and efficacy of standard therapy with DAAs in a large Italian cohort of with hemoglobinopathies, chronic HCV infection and advanced liver fibrosis.
Detailed description
Many patients with hemoglobinopathies have been infected with hepatitis C virus (HCV) through blood transfusion, mostly before screening of blood donors was introduced in 1992. The reported prevalence of anti-HCV-positive thalassemia patients varies between 4.4% in Turkey and 85.4% in Italy. HCV infection is associated with decompensated cirrhosis, hepatocellular carcinoma and other liver complications, especially if left untreated. Prevalence of cirrhosis in thalassemia patients up to 32% have been reported.
Thalassemia patients with cirrhosis have an increased risk of death. Progression of liver fibrosis is strongly related to the presence of chronic HCV infection and extent of iron overload. Thalassemia patients with elevated serum aminotransferase levels for >6 months should be tested for HCV infection and, in the event of HCV infection, HCV genotyping is recommended in order to plan antiviral therapy and the likelihood of response. Noninvasive transient elastography (FibroScan®) can be used to determine the presence of fibrosis in thalassemia patients with HCV infection.
Effective chelation therapy and treatment of HCV infection are needed in order to prevent liver complications and decrease morbidity and mortality. For many years, pegylated interferon (peg-IFN) plus ribavirin was the standard of care for the treatment of chronic HCV infection and decompensated cirrhosis. Studies of peg-IFN plus ribavirin have demonstrated sustained virological response (SVR) rates of 25-64% in patients with thalassemia and HCV infection. However, peg-IFN and ribavirin are both associated with anemia. Ribavirin-associated hemolysis leads to an increased requirement for blood transfusions, which in turn can lead to worsening of iron overload. Therefore, European Association for the Study of the Liver (EASL) 2015 guidelines recommend interferon-free regimens for the treatment of HCV infection in patients with hemoglobinopathies. The aim of this study was to evaluate the safety and efficacy of DAA standard regimens in patients with hemoglobinopathies and chronic HCV liver disease treated in Italy.
Antiviral treatments were administered according to Italian Medicines Agency (AIFA) guidelines.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV RNA positive | – | Drug: Antiviral drugshemoglobinopathies with hepatites C treated with antiviral drugs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with hemoglobinopathies with cronic hepatitis C
Key inclusion criteria (1 listed)
- Patients with hemoglobinopathies, chronic hepatitis due to HCV and the presence of fibrosis (defined as Fibroscan® stiffness ≥10 kPa) or a bioptic evaluation of cirrhosis (same ISHAK fibrosis score) determined within 6 months previously. Patients with extrahepatic manifestations of chronic hepatitis C virus infection (cryoglobulinemia with organ damage, B-lymphoproliferative disorders) were also included.
Key exclusion criteria (1 listed)
- Patients with active cancer, including hepatocellular carcinoma, and pregnant or lactating females were excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antiviral drugsAlso: Direct-acting antiviral drugs'sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir | Drug | HCV RNA positive |
Primary outcome
Change in the number of participants with undetectable serum HCV RNA is being assessed at the end of treatment
Time frame: baseline and 12 weeks
The quantification of hepatitis virus particles in serum is assessed and expressed in IU/mL (IU, international units ) through quantitation of virus ribonucleic acid by real time polymerase chain reaction (PCR).
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 11 May 2017.
- Individual participant dataSharing planned: No
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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.
Vito Di Marco, MD study director
University of Palermo, Palermo, Italy
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Hemoglobinopathies, run by Società Italiana Talassemie ed Emoglobinopatie.
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 1 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 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in the number of participants with undetectable serum HCV RNA is being assessed at the end of treatment (time frame: baseline and 12 weeks). 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 11 May 2017.