NCT03381859: CLEAR-C4

Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4

Withdrawn Phase 4 Last updated 20 April 2020

What this trial tests

Phase 4 trial testing Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] in Hepatitis C Virus Infection, Response to Therapy of. Withdrawn.

Timeline

1 December 2019

Primary endpoint
1 June 2020

1 June 2020

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 4
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	1 December 2019
Primary completion	1 June 2020
Estimated completion	1 June 2020
Sites	1 location across Egypt

Drugs / interventions tested

• Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER] — full drug profile →

Conditions studied

• Hepatitis C Virus Infection, Response to Therapy of — all drugs for Hepatitis C Virus Infection, Response to Therapy of →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 21 to 70, any sex, with Hepatitis C Virus Infection, Response to Therapy of. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Primary Efficacy Objective

-To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification \[LLOQ\] for 12 weeks (SVR12) after completion of the study treatment course

Secondary Objectives

* To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful endpoints (Week 2, 8 and 12 \[End of Treatment - EOT\]) and 24 (SVR12)
* To assess the safety and tolerability of a 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC.
* To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in the same patients before treatment and EOT and SVR12

Clinical hypotheses.

Primary Efficacy Hypothesis

\- A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of patients within 2 weeks of treatment, and at least 95% will have an SVR12.

Secondary hypotheses

* A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12 (EOT) and 24 (SVR12)
* Treatment will be safe and well-tolerated in these patients, as determined by the type and number of adverse events identified through laboratory testing, vital signs and physical examinations.
* In these patients with liver fibrosis before treatment, the liver fibrosis as assessed by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12

Publications & conference data

No peer-reviewed publications indexed yet for this trial.