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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02836925 on ClinicalTrials.gov