Glecaprevir/pibrentasvir for Hepatitis C

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Hepatitis C+4 More
Glecaprevir/pibrentasvir - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether receiving a kidney from a donor with HCV and being treated for HCV at the same time is safe and effective for people waiting for a kidney transplant.

Eligible Conditions
  • Hepatitis C
  • End Stage Renal Disease (ESRD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 12 weeks after completing therapy

Week 12
Hepatitis C

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

GLE/PIB for 8, 12, or 16 Weeks
16%PRURITUS
6%HYPERTENSION
6%PRURITUS GENERALISED
1%EXTREMITY NECROSIS
1%URINARY TRACT INFECTION
1%ANAEMIA
1%PNEUMONIA
1%BRONCHITIS
1%HYPOKALAEMIA
1%MUSCULOSKELETAL PAIN
1%NEPHROLITHIASIS
1%MYELOPATHY
1%VENOUS STENOSIS
1%PULMONARY OEDEMA
1%ILEUS
1%PLEURAL EFFUSION
1%PERIPHERAL ARTERY STENOSIS
1%HYPERGLYCAEMIA
1%PRESYNCOPE
This histogram enumerates side effects from a completed 2018 Phase 3 trial (NCT03069365) in the GLE/PIB for 8, 12, or 16 Weeks ARM group. Side effects include: PRURITUS with 16%, HYPERTENSION with 6%, PRURITUS GENERALISED with 6%, EXTREMITY NECROSIS with 1%, URINARY TRACT INFECTION with 1%.

Trial Design

1 Treatment Group

Deceased donor HCV RNA PCR+
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Glecaprevir/pibrentasvir · No Placebo Group · Phase 4

Deceased donor HCV RNA PCR+
Drug
Experimental Group · 1 Intervention: Glecaprevir/pibrentasvir · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pibrentasvir
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks after completing therapy

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,055 Previous Clinical Trials
30,975,404 Total Patients Enrolled
18 Trials studying Hepatitis C
172,440 Patients Enrolled for Hepatitis C
Niraj Desai, MDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no living kidney donors.
You have a calculated panel reactive anti-HLA antibody (flow cPRA) below 80%.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: November 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.