Ledipasvir+Sofosbuvir and Sofosbuvir+Velpatasvir for Pts With Indolent Bcell Lymphoma Associated With HCV Infection
NCT02836925 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2023-03-31
Summary
This is a non-randomized, a single arm, phase II multicentre study of sofosbuvir plus ledipasvir (genotype 1 and 4) or sofosbuvir plus velpatasvir (genotype 2 and 3) for patients with hepatitis C virus-associated indolent B-cell lymphomas (HCV-RNA positive).
Conditions
- Indolent B-cell Lymphoma
- Hepatitis C
Interventions
- DRUG
-
Ledipasvir+Sofosbuvir
Patients with genotype 1 or genotype 4 Ledipasvir 90 mg + Sofosbuvir 400 mg * 12 weeks in previously untreated infected patients * 24 weeks for previously treated patients with uncertain subsequent retreatment options
- DRUG
-
Sofosbuvir+Velpatasvir
Patients with genotype 2 or genotype 3 Sofosbuvir 400 mg + Velpatasvir 100 mg · 12 weeks of treatment
Sponsors & Collaborators
-
Fondazione Italiana Linfomi - ETS
lead OTHER
Principal Investigators
-
Luca Arcaini · Fondazione IRCCS Policlinico San Matteo di Pavia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2020-02-29
- Completion
- 2022-11-30
Countries
- Italy
Study Locations
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