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NCT03250910

Generic VEL/SOF With or Without RBV for HIV/HCV Coinfected Patients

Completed Phase 4 Last updated 8 December 2017
What this trial tests

Phase 4 trial testing Sofosbuvir and Velpatasvir in Hepatitis C Virus Infection, Response to Therapy of in 228 participants. Completed in 31 October 2017.

Timeline
1 August 2016
Primary endpoint
15 July 2017
31 October 2017

Quick facts

Lead sponsorNational Taiwan University Hospital
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment228
Start date1 August 2016
Primary completion15 July 2017
Estimated completion31 October 2017
Sites2 locations across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

National Taiwan University Hospital

Who can join

20 and older, any sex, with Hepatitis C Virus Infection, Response to Therapy of or Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Data are limited regarding the effectiveness and safety of generic velpatasvir plus sofosbuvir (VEL/SOF) with or without ribavirin (RBV) for the treatment of hepatitis C virus (HCV) in patients with human immunodeficiency virus (HIV) coinfection. We aim to compare the effectiveness and safety of VEL/SOF with and without RBV for 12 weeks in HIV/HCV-coinfected and HCV-monoinfected patients The antiviral responses and the adverse events (AEs) are compare between the two groups. The characteristics potentially related to sustained virologic response 12 weeks off therapy (SVR12) are analyzed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Sofosbuvir and Velpatasvir

Trials testing the same drug.

Other recruiting trials for Hepatitis C Virus Infection, Response to Therapy of

Currently open trials in the same condition.

Other National Taiwan University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03250910.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing