Current Treatment of HCV Infection After HSCT

NCT03014986 | Completed

• 1 other identifier: (4)8414107
• Study Type: observational
• Target: 46
• Locations: 3 countries
• Sites: 7

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.

Conditions

Hepatitis C

Keywords

HCV

Outcome Measures

Primary Outcomes (1)

• Description of treatment approach of HCV infection

  The type of treatment (drugs, doses) for HCV will be described.

  6 months

Secondary Outcomes (1)

• SVR at week 12 and 24 after the EOT, yes/no

  24 weeks

Study Arms (2)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

Sponsors & Collaborators

• European Society for Blood and Marrow Transplantation: lead

Study Sites (7)

Centre Hospitalier de Meaux

Meaux, 77104, France

Location

Ospedale San Raffaele s.r.l.

Milan, 20132, Italy

Location

Ospedale Santa Maria della Misericordia

Perugia, 06132, Italy

Location

Ospedale Civile

Pescara, 65125, Italy

Location

Policlinico G.B. Rossi

Verona, 37134, Italy

Location

Hospital Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital de la Princesa

Madrid, 28006, Spain

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Simone Cesaro

  Paediatric Haematology Oncology, Policlinico G.B. Rossi

  STUDY CHAIR

• Malgorzata Mikulska

  University of Genoa, San Martino University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 9, 2017
• Study Start: December 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

FR (1); IT (4); ES (2)