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Current Treatment of HCV Infection After HSCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014986
Recruitment Status : Unknown
Verified January 2017 by European Group for Blood and Marrow Transplantation.
Recruitment status was:  Recruiting
First Posted : January 9, 2017
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
European Group for Blood and Marrow Transplantation

Brief Summary:

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.


Condition or disease
Hepatitis C

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Current Treatment of HCV Infection After HSCT
Study Start Date : December 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C

Group/Cohort
Patients who receive HCV treatment
HSCT patients with HCV who are receiving (or has recently received) HCV treatment
Patients who do not receive HCV treatment
HSCT patients with HCV who have not received treatment



Primary Outcome Measures :
  1. Description of treatment approach of HCV infection [ Time Frame: 6 months ]
    The type of treatment (drugs, doses) for HCV will be described.


Secondary Outcome Measures :
  1. SVR at week 12 and 24 after the EOT, yes/no [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All HCV-RNA positive patients transplanted from anytime until May 2017, followed from December 2015 to November 2017
Criteria

Inclusion Criteria:

  • HSCT recipients (allogeneic and autologous) with HCV infection
  • Transplanted from anytime until May 2017, followed from December 2015 to November 2017.

Exclusion Criteria:

-


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): NCT03014986


Contacts
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Contact: Jennifer Hoek, MD +31715265668 j.d.c.hoek@lumc.nl

Locations
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France
Centre Hospitalier de Meaux Recruiting
Meaux, France, 77104
Contact: Loic Fouillard, MD    01 64 35 38 76    l-fouillard@ch-meaux.fr   
Italy
Ospedale San Raffaele s.r.l. Recruiting
Milano, Italy, 20132
Contact: Fabio Ciceri, MD    39-02-264-339-03    ciceri.fabio@hsr.it   
Ospedale Santa Maria della Misericordia Recruiting
Perugia, Italy, 06132
Contact: Andrea Velardi, MD    39-075-578-4124    velardi@unipg.it   
Ospedale Civile Recruiting
Pescara, Italy, 65125
Contact: Paolo Di Bartolomeo, MD    39-085-425-2581    pescaratmo@virgilio.it   
Policlinico G.B. Rossi Recruiting
Verona, Italy, 37134
Contact: Simone Cesaro, MD    +39 045 812 4668    simone.cesaro@ospedaleuniverona.it   
Spain
Hospital Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08041
Contact: Jorge Sierra, MD    34-93-556-5649    tolius@santpau.cat   
Hospital de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Adrián Alegre, MD    34-91-520-2316    adrian.alegre@telefonica.net   
Sponsors and Collaborators
European Group for Blood and Marrow Transplantation
Investigators
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Study Chair: Simone Cesaro Paediatric Haematology Oncology, Policlinico G.B. Rossi
Principal Investigator: Malgorzata Mikulska University of Genoa, San Martino University Hospital
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Responsible Party: European Group for Blood and Marrow Transplantation
ClinicalTrials.gov Identifier: NCT03014986    
Other Study ID Numbers: (4)8414107
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by European Group for Blood and Marrow Transplantation:
HCV
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections