<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03014986</url>
  </required_header>
  <id_info>
    <org_study_id>(4)8414107</org_study_id>
    <nct_id>NCT03014986</nct_id>
  </id_info>
  <brief_title>Current Treatment of HCV Infection After HSCT</brief_title>
  <official_title>Current Treatment of HCV Infection After HSCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Society for Blood and Marrow Transplantation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Society for Blood and Marrow Transplantation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The availability of novel therapies with DAAs might prompt clinicians caring for HSCT&#xD;
      recipients with HCV infection to prescribe the treatment more frequently and possibly earlier&#xD;
      after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most&#xD;
      appropriate one is not straightforward. It depends not only on its efficacy, toxicity and&#xD;
      rate of pharmacological interactions, but also on availability (both through healthcare&#xD;
      system and in expanded access programs), and cost.&#xD;
&#xD;
      This observational prospective study will focus on treatment strategies in HSCT recipients&#xD;
      with HCV infection. The main focus will be the therapeutic approach, the combination of drugs&#xD;
      chosen, the length of treatment and the outcome. The main reasons for treating or not&#xD;
      treating HSCT recipients with HCV infection will be also explored. Compared to previous&#xD;
      cohorts, this study might provide additional data in the area of non-invasive assessment of&#xD;
      fibrosis, HCV-RNA levels and genotyping.&#xD;
&#xD;
      In order to get as much data as possible on HCV treatment, patients with chronic HCV&#xD;
      infection transplanted during the last 10 years will be included.&#xD;
&#xD;
      Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016&#xD;
      will be reported.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      According to previous EBMT studies, approximately 6% of HSCT recipients were HCV-positive&#xD;
      (Locasciulli et al. Transplantation 1999). Despite the fact that HSCT recipients with chronic&#xD;
      HCV infection are prone to HCV-morbidity (end stage liver disease, hepatocellular carcinoma,&#xD;
      the need for liver transplant), only about half (44% and 61%) of long term survivors of HSCT&#xD;
      were offered specific treatment (Ljungman et al. BMT 2012; Peffault de Latour et al. BMT&#xD;
      2005). The median time from HSCT to treatment was long and the efficacy was far from&#xD;
      satisfactory (approximately 50%) (Ljungman et al. BMT 2012). Since 2011 novel oral directly&#xD;
      acting antiviral agents (DAA) have been developed and marketed. DAAs offer the advantage of&#xD;
      higher efficacy, shorter duration and reduced treatment toxicity; together with the&#xD;
      possibility of exclusively oral, interferon- or interferon/ribavirin-free regimens.&#xD;
&#xD;
      Short description of the study:&#xD;
&#xD;
      The availability of novel therapies with DAAs might prompt clinicians caring for HSCT&#xD;
      recipients with HCV infection to prescribe the treatment more frequently and possibly earlier&#xD;
      after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most&#xD;
      appropriate one is not straightforward. It depends not only on its efficacy, toxicity and&#xD;
      rate of pharmacological interactions, but also on availability (both through healthcare&#xD;
      system and in expanded access programs), and cost.&#xD;
&#xD;
      This observational prospective study will focus on treatment strategies in HSCT recipients&#xD;
      with HCV infection. The main focus will be the therapeutic approach, the combination of drugs&#xD;
      chosen, the length of treatment and the outcome. The main reasons for treating or not&#xD;
      treating HSCT recipients with HCV infection will be also explored. Compared to previous&#xD;
      cohorts, this study might provide additional data in the area of non-invasive assessment of&#xD;
      fibrosis, HCV-RNA levels and genotyping.&#xD;
&#xD;
      In order to get as much data as possible on HCV treatment, patients with chronic HCV&#xD;
      infection transplanted during the last 10 years will be included.&#xD;
&#xD;
      Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016&#xD;
      will be reported.&#xD;
&#xD;
      Research design:&#xD;
&#xD;
      Over the period of 24 months, all HCV-RNA positive patients who received autologous or&#xD;
      allogeneic transplant from any time to May 2017 and are followed at transplant centres will&#xD;
      be enrolled.&#xD;
&#xD;
      Data regarding the patients who are receiving (or has recently received) HCV treatment (group&#xD;
      1) will be collected in Form 1 (FORM 1 - HCV TREATMENT) and 6 months after the end of&#xD;
      treatment in Form 4 (FORM 4 - POST HCV TREATMENT FOLLOW UP FORM)&#xD;
&#xD;
      Data regarding the baseline characteristics of HCV-RNA positive patients who are not being&#xD;
      treated (group 2) will be collected in Form 2 (FORM 2 - HCV-RNA positive patients - BASELINE)&#xD;
      and then at the end of the recruitment period (December 2017 +/- 3 months) in Form 3 (FORM 3&#xD;
      - HCV-RNA positive patients - FOLLOW UP FORM).&#xD;
&#xD;
      If patients from group 2 start treatment, their data thereafter should be reported in Form 1&#xD;
      and then Form 4.&#xD;
&#xD;
      Including: Duration of the study Recruitment period (visits date for HCV-RNA+ patients)&#xD;
      starts December 2015 till November 2017. All the patients will be followed for a minimum&#xD;
      additional period of 6 months from the end of recruitment period.&#xD;
&#xD;
      Patients, in whom HCV treatment started before December 2015, will be also included if&#xD;
      followed during the study period with the aim of establishing the efficacy of the recent&#xD;
      HCV-treatment (HCV-RNA testing to establish SVR at 12 and 24 weeks after EOT).&#xD;
&#xD;
      Study Population:&#xD;
&#xD;
      All HCV-RNA positive patients transplanted from anytime until May 2017, followed from&#xD;
      December 2015 to November 2017.&#xD;
&#xD;
      Data Collection &amp; Statistical Analysis Plan:&#xD;
&#xD;
      All data collection will be performed by the IDWP Data Office (Leiden) according to EBMT&#xD;
      guidelines.&#xD;
&#xD;
      Data from Med A + Med B with the following:&#xD;
&#xD;
      At the first visit occurring between January 2016 and December 2017:&#xD;
&#xD;
        -  Date of diagnosis of HCV&#xD;
&#xD;
        -  Quantitative HCV-RNA&#xD;
&#xD;
        -  Genotype of HCV, IL28B polymorphism in case of G1 and G4&#xD;
&#xD;
        -  Fibrosis according to elastography and/or biopsy (grade and date) and/or serological&#xD;
           assays&#xD;
&#xD;
        -  Previous anti-HCV treatment (date, type, duration, side-effects, outcome)&#xD;
&#xD;
        -  HBV status (chronic active infection, chronic inactive infection, resolved infection,&#xD;
           immunised) and HIV status&#xD;
&#xD;
        -  Clinical data: ALT, albumin, PT, serum creatinine, encephalopathy, ascites, white cell&#xD;
           count, Hb, platelets, dialysis, hepatocellular carcinoma (HCC)&#xD;
&#xD;
        -  Concomitant pharmacological treatment&#xD;
&#xD;
        -  Occurrence of VOD (grade, date)&#xD;
&#xD;
        -  Acute or chronic GVHD (grade, date)&#xD;
&#xD;
      At the end of the study for not treated HCV-RNA- positive patients (December 2017, +/- 3&#xD;
      months):&#xD;
&#xD;
        -  Quantitative HCV RNA (date)&#xD;
&#xD;
        -  Fibrosis according to elastography and/or biopsy (grade and date) and/or serological&#xD;
           assays&#xD;
&#xD;
        -  Chronic GvHD (grade, date)&#xD;
&#xD;
        -  Clinical data: ALT, albumin, PT, serum creatinine, encephalopathy, ascites, white cell&#xD;
           count, Hb, platelets, dialysis&#xD;
&#xD;
        -  Presence of hepatocellular carcinoma (HCC)&#xD;
&#xD;
        -  Reason for treatment or reason for not starting HCV-treatment&#xD;
&#xD;
        -  Reason for death, if applicable&#xD;
&#xD;
      In case of treatment:&#xD;
&#xD;
        -  Treatment regimen (drugs, length)&#xD;
&#xD;
        -  On treatment response (all HCV-RNA levels and dates)&#xD;
&#xD;
        -  Concomitant pharmacological treatment&#xD;
&#xD;
        -  SVR at 12 and 24 weeks after the end of treatment&#xD;
&#xD;
        -  Reason for discontinuation (EOT, side tolerability, etc.)&#xD;
&#xD;
        -  Treatment associated side effects (type, grade, its treatment, date of onset and date of&#xD;
           resolution), including pharmacological interactions&#xD;
&#xD;
        -  Treatment payment (national healthcare system, expanded access, research protocol, etc.)&#xD;
&#xD;
      Statistical analysis&#xD;
&#xD;
      Main outcome variables:&#xD;
&#xD;
        1. Description of treatment approach of HCV infection The type of treatment (drugs, doses)&#xD;
           for HCV will be described. The following variables will be described in patients with&#xD;
           and without treatment for HCV: age, type of transplant, type of underlying disease,&#xD;
           status of the underlying disease, presence of relapse, time from HSCT (from Med A form);&#xD;
           HCV-RNA level, grade of fibrosis, genotype, previous acute or chronic GVHD (grade max.),&#xD;
           Child-Pugh score (to be calculated from clinical variables), presence of HCC.&#xD;
&#xD;
        2. SVR at week 12 and 24 after the EOT, yes/no The following variables will be described in&#xD;
           patients with and without sustained viral response (SVR) at week 12 and 24 after the&#xD;
           EOT: age, type of transplant, type of underlying disease, status of the underlying&#xD;
           disease, presence of relapse, time from HSCT (from Med A form); HCV-RNA level, grade of&#xD;
           fibrosis, genotype and polymorphism if applicable, previous acute or chronic GVHD (grade&#xD;
           max.), Child- Pugh score (to be calculated from clinical variables), presence of HCC,&#xD;
           type of treatment (particular regimen, interferon-free vs. interferon-based regimen,&#xD;
           etc), toxicity, on treatment response, presence of possible interacting drugs.&#xD;
&#xD;
      Categorical variables to be compared according to chi-square test of exact Fisher's test if&#xD;
      applicable, continuous variables to be compared with Mann-Whitney test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">July 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Description of treatment approach of HCV infection</measure>
    <time_frame>6 months</time_frame>
    <description>The type of treatment (drugs, doses) for HCV will be described.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SVR at week 12 and 24 after the EOT, yes/no</measure>
    <time_frame>24 weeks</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">46</enrollment>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Patients who receive HCV treatment</arm_group_label>
    <description>HSCT patients with HCV who are receiving (or has recently received) HCV treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients who do not receive HCV treatment</arm_group_label>
    <description>HSCT patients with HCV who have not received treatment</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All HCV-RNA positive patients transplanted from anytime until May 2017, followed from&#xD;
        December 2015 to November 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HSCT recipients (allogeneic and autologous) with HCV infection&#xD;
&#xD;
          -  Transplanted from anytime until May 2017, followed from December 2015 to November&#xD;
             2017.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Simone Cesaro</last_name>
    <role>Study Chair</role>
    <affiliation>Paediatric Haematology Oncology, Policlinico G.B. Rossi</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Malgorzata Mikulska</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Genoa, San Martino University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier de Meaux</name>
      <address>
        <city>Meaux</city>
        <zip>77104</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele s.r.l.</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria della Misericordia</name>
      <address>
        <city>Perugia</city>
        <zip>06132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile</name>
      <address>
        <city>Pescara</city>
        <zip>65125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico G.B. Rossi</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HCV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03014986
org study id: (4)8414107
nct id: NCT03014986
lead sponsor: 
has dmc: No
The availability of novel therapies with DAAs might prompt clinicians caring for HSCT
      recipients with HCV infection to prescribe the treatment more frequently and possibly earlier
      after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most
      appropriate one is not straightforward. It depends not only on its efficacy, toxicity and
      rate of pharmacological interactions, but also on availability (both through healthcare
      system and in expanded access programs), and cost.

      This observational prospective study will focus on treatment strategies in HSCT recipients
      with HCV infection. The main focus will be the therapeutic approach, the combination of drugs
      chosen, the length of treatment and the outcome. The main reasons for treating or not
      treating HSCT recipients with HCV infection will be also explored. Compared to previous
      cohorts, this study might provide additional data in the area of non-invasive assessment of
      fibrosis, HCV-RNA levels and genotyping.

      In order to get as much data as possible on HCV treatment, patients with chronic HCV
      infection transplanted during the last 10 years will be included.

      Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016
      will be reported.
Introduction:

      According to previous EBMT studies, approximately 6% of HSCT recipients were HCV-positive
      (Locasciulli et al. Transplantation 1999). Despite the fact that HSCT recipients with chronic
      HCV infection are prone to HCV-morbidity (end stage liver disease, hepatocellular carcinoma,
      the need for liver transplant), only about half (44% and 61%) of long term survivors of HSCT
      were offered specific treatment (Ljungman et al. BMT 2012; Peffault de Latour et al. BMT
      2005). The median time from HSCT to treatment was long and the efficacy was far from
      satisfactory (approximately 50%) (Ljungman et al. BMT 2012). Since 2011 novel oral directly
      acting antiviral agents (DAA) have been developed and marketed. DAAs offer the advantage of
      higher efficacy, shorter duration and reduced treatment toxicity; together with the
      possibility of exclusively oral, interferon- or interferon/ribavirin-free regimens.

      Short description of the study:

      The availability of novel therapies with DAAs might prompt clinicians caring for HSCT
      recipients with HCV infection to prescribe the treatment more frequently and possibly earlier
      after HSCT. Since numerous possible therapeutic combinations exist, the choice of the most
      appropriate one is not straightforward. It depends not only on its efficacy, toxicity and
      rate of pharmacological interactions, but also on availability (both through healthcare
      system and in expanded access programs), and cost.

      This observational prospective study will focus on treatment strategies in HSCT recipients
      with HCV infection. The main focus will be the therapeutic approach, the combination of drugs
      chosen, the length of treatment and the outcome. The main reasons for treating or not
      treating HSCT recipients with HCV infection will be also explored. Compared to previous
      cohorts, this study might provide additional data in the area of non-invasive assessment of
      fibrosis, HCV-RNA levels and genotyping.

      In order to get as much data as possible on HCV treatment, patients with chronic HCV
      infection transplanted during the last 10 years will be included.

      Finally the prevalence of HCV-RNA positive patients among those transplanted in the year 2016
      will be reported.

      Research design:

      Over the period of 24 months, all HCV-RNA positive patients who received autologous or
      allogeneic transplant from any time to May 2017 and are followed at transplant centres will
      be enrolled.

      Data regarding the patients who are receiving (or has recently received) HCV treatment (group
      1) will be collected in Form 1 (FORM 1 - HCV TREATMENT) and 6 months after the end of
      treatment in Form 4 (FORM 4 - POST HCV TREATMENT FOLLOW UP FORM)

      Data regarding the baseline characteristics of HCV-RNA positive patients who are not being
      treated (group 2) will be collected in Form 2 (FORM 2 - HCV-RNA positive patients - BASELINE)
      and then at the end of the recruitment period (December 2017 +/- 3 months) in Form 3 (FORM 3
      - HCV-RNA positive patients - FOLLOW UP FORM).

      If patients from group 2 start treatment, their data thereafter should be reported in Form 1
      and then Form 4.

      Including: Duration of the study Recruitment period (visits date for HCV-RNA+ patients)
      starts December 2015 till November 2017. All the patients will be followed for a minimum
      additional period of 6 months from the end of recruitment period.

      Patients, in whom HCV treatment started before December 2015, will be also included if
      followed during the study period with the aim of establishing the efficacy of the recent
      HCV-treatment (HCV-RNA testing to establish SVR at 12 and 24 weeks after EOT).

      Study Population:

      All HCV-RNA positive patients transplanted from anytime until May 2017, followed from
      December 2015 to November 2017.

      Data Collection & Statistical Analysis Plan:

      All data collection will be performed by the IDWP Data Office (Leiden) according to EBMT
      guidelines.

      Data from Med A + Med B with the following:

      At the first visit occurring between January 2016 and December 2017:

        -  Date of diagnosis of HCV

        -  Quantitative HCV-RNA

        -  Genotype of HCV, IL28B polymorphism in case of G1 and G4

        -  Fibrosis according to elastography and/or biopsy (grade and date) and/or serological
           assays

        -  Previous anti-HCV treatment (date, type, duration, side-effects, outcome)

        -  HBV status (chronic active infection, chronic inactive infection, resolved infection,
           immunised) and HIV status

        -  Clinical data: ALT, albumin, PT, serum creatinine, encephalopathy, ascites, white cell
           count, Hb, platelets, dialysis, hepatocellular carcinoma (HCC)

        -  Concomitant pharmacological treatment

        -  Occurrence of VOD (grade, date)

        -  Acute or chronic GVHD (grade, date)

      At the end of the study for not treated HCV-RNA- positive patients (December 2017, +/- 3
      months):

        -  Quantitative HCV RNA (date)

        -  Fibrosis according to elastography and/or biopsy (grade and date) and/or serological
           assays

        -  Chronic GvHD (grade, date)

        -  Clinical data: ALT, albumin, PT, serum creatinine, encephalopathy, ascites, white cell
           count, Hb, platelets, dialysis

        -  Presence of hepatocellular carcinoma (HCC)

        -  Reason for treatment or reason for not starting HCV-treatment

        -  Reason for death, if applicable

      In case of treatment:

        -  Treatment regimen (drugs, length)

        -  On treatment response (all HCV-RNA levels and dates)

        -  Concomitant pharmacological treatment

        -  SVR at 12 and 24 weeks after the end of treatment

        -  Reason for discontinuation (EOT, side tolerability, etc.)

        -  Treatment associated side effects (type, grade, its treatment, date of onset and date of
           resolution), including pharmacological interactions

        -  Treatment payment (national healthcare system, expanded access, research protocol, etc.)

      Statistical analysis

      Main outcome variables:

        1. Description of treatment approach of HCV infection The type of treatment (drugs, doses)
           for HCV will be described. The following variables will be described in patients with
           and without treatment for HCV: age, type of transplant, type of underlying disease,
           status of the underlying disease, presence of relapse, time from HSCT (from Med A form);
           HCV-RNA level, grade of fibrosis, genotype, previous acute or chronic GVHD (grade max.),
           Child-Pugh score (to be calculated from clinical variables), presence of HCC.

        2. SVR at week 12 and 24 after the EOT, yes/no The following variables will be described in
           patients with and without sustained viral response (SVR) at week 12 and 24 after the
           EOT: age, type of transplant, type of underlying disease, status of the underlying
           disease, presence of relapse, time from HSCT (from Med A form); HCV-RNA level, grade of
           fibrosis, genotype and polymorphism if applicable, previous acute or chronic GVHD (grade
           max.), Child- Pugh score (to be calculated from clinical variables), presence of HCC,
           type of treatment (particular regimen, interferon-free vs. interferon-based regimen,
           etc), toxicity, on treatment response, presence of possible interacting drugs.

      Categorical variables to be compared according to chi-square test of exact Fisher's test if
      applicable, continuous variables to be compared with Mann-Whitney test.
observational model: Case-Only
time perspective: Prospective
measure: Description of treatment approach of HCV infection
time frame: 6 months
description: The type of treatment (drugs, doses) for HCV will be described.
measure: SVR at week 12 and 24 after the EOT, yes/no
time frame: 24 weeks
arm group label: Patients who receive HCV treatment
description: HSCT patients with HCV who are receiving (or has recently received) HCV treatment
arm group label: Patients who do not receive HCV treatment
description: HSCT patients with HCV who have not received treatment
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Simone Cesaro
role: Study Chair
affiliation: Paediatric Haematology Oncology, Policlinico G.B. Rossi
last name: Malgorzata Mikulska
role: Principal Investigator
affiliation: University of Genoa, San Martino University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Italy
country: Spain
responsible party type: Sponsor
mesh term: Hepatitis C
sharing ipd: Undecided