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Simplifying HCV Treatment in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)

NCT03888729 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-09-11

No results posted yet for this study

Summary

The main purpose of the study is to determine the antiviral efficacy and evaluate the safety and tolerability of sofosbuvir/ velpatasvir (SOF/VEL) and sofosbuvir/ velpatasvir/ voxilaprevir (SOF/VEL/VOX) used to treat individuals with chronic hepatitis C virus infection in Rwanda adults.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

sofosbubir/velpatasvir

SOF/VEL (400 mg/100 mg) FDC once daily

DRUG

sofosbubir/velpatasvir/voxilaprevir

SOF/VEL/VOX (400 mg/100 mg/100 mg) FDC once daily

Sponsors & Collaborators

  • Partners in Health

    lead OTHER

Principal Investigators

  • Neil Gupta, MD, MPH · Partners In Health; Brigham and Women's Hospital; Harvard Medical School

  • Fredrick Kateera, MD, PhD · Partners In Health/Inshuti Mu Buzima - Rwanda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2020-03-31
Completion
2020-03-31
FDA Drug
Yes

Countries

  • Rwanda

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 NCT03888729 on ClinicalTrials.gov