Trial intelligence / Profile preview

The No One Waits Study

NCT03987503Phase 4

Key facts

Status: Completed
Start: Jul 2020
Primary completion: Oct 2022
Countries: 1
Sponsor: University of California, San Francisco
Modality: Reversible Covalent Inhibitors, Allosteric Modulators, Orthosteric Ligands

Drugs: velpatasvir
Conditions: hepatitis C (HCV)

Overview

Phase 4, open-label trial of velpatasvir in hepatitis C (HCV) (2 arms), sponsored by University of California, San Francisco. Primary endpoint: Sustained Virologic Response at 12-weeks. Started Jul 2020; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Point-of-Diagnosis Treatment
Immediate initiation of Epclusa upon diagnosis.
Passive Observation
Standard of care referral.

Who it enrols

Adults >= 18 years with chronic HCV (RNA positive), including those with lifetime injection drug use. Excludes decompensated cirrhosis, pregnancy, and prior NS5a failure.

Endpoints

Primary

Sustained Virologic Response at 12-weeks12 weeks post-treatment

Secondary

Time From Anti-HCV Testing to Treatment Initiation12 weeks
Treatment Completion24 weeks
Undetectable RNA at Treatment Completion12 weeks
Number of Persons Who Decline POD Treatment1 day

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