NCT03888729

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

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World: Pangenotypic and Retreatment Study (SHARED3)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Partners in Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-label single-arm study that will examine the antiviral efficacy, safety and tolerability of 12 weeks daily therapy with fixed dose combination (FDC) of SOF/VEL and SOF/VEL/VOX administered respectively in HCV-infected treatment-naïve adult participants and in HCV-infected individuals with a history of virologic failure to SOF/LDV or other DAA-containing regimen. A total of 100 participants will be enrolled in this portion of the SHARED study, labelled the "SHARED 3 study": 60 treatment-naïve participants and 40 individuals with history of virologic failure to SOF/LDV or other DAA-containing regimen

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-08-26
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2019-03-25
• Last updated: 2019-09-11

Locations

1 site across 1 country: Rwanda

Regulatory

• FDA-regulated drug study