Current Treatment of HCV Infection After HSCT
|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
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|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
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
- Description of treatment approach of HCV infection [ Time Frame: 6 months ]The type of treatment (drugs, doses) for HCV will be described.
- SVR at week 12 and 24 after the EOT, yes/no [ Time Frame: 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014986
|Contact: Jennifer Hoek, MDemail@example.com|
|Centre Hospitalier de Meaux||Recruiting|
|Meaux, France, 77104|
|Contact: Loic Fouillard, MD 01 64 35 38 76 firstname.lastname@example.org|
|Ospedale San Raffaele s.r.l.||Recruiting|
|Milano, Italy, 20132|
|Contact: Fabio Ciceri, MD 39-02-264-339-03 email@example.com|
|Ospedale Santa Maria della Misericordia||Recruiting|
|Perugia, Italy, 06132|
|Contact: Andrea Velardi, MD 39-075-578-4124 firstname.lastname@example.org|
|Pescara, Italy, 65125|
|Contact: Paolo Di Bartolomeo, MD 39-085-425-2581 email@example.com|
|Policlinico G.B. Rossi||Recruiting|
|Verona, Italy, 37134|
|Contact: Simone Cesaro, MD +39 045 812 4668 firstname.lastname@example.org|
|Hospital Santa Creu i Sant Pau||Recruiting|
|Barcelona, Spain, 08041|
|Contact: Jorge Sierra, MD 34-93-556-5649 email@example.com|
|Hospital de la Princesa||Recruiting|
|Madrid, Spain, 28006|
|Contact: Adrián Alegre, MD 34-91-520-2316 firstname.lastname@example.org|
|Study Chair:||Simone Cesaro||Paediatric Haematology Oncology, Policlinico G.B. Rossi|
|Principal Investigator:||Malgorzata Mikulska||University of Genoa, San Martino University Hospital|