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Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

NCT02964091 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-09-21

No results posted yet for this study

Summary

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

sofosbuvir/ledipasvir

Sponsors & Collaborators

  • Partners in Health

    lead OTHER

Principal Investigators

  • Neil Gupta, MD · Partners in Health

  • Jules Kabahizi, MD · Rwanda Military Hospital

  • Aimable Mbituyumuremyi, MD · Rwanda Biomedical Centre

  • Philip Grant, MD · Stanford University

  • Claude M Muvunyi, MD · University of Rwanda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2020-08-28
Completion
2020-08-28

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 NCT02964091 on ClinicalTrials.gov