Ignite Creation Date:
2024-05-06 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03381859
Status:
WITHDRAWN
Last Update Posted:
2020-04-20
First Post:
2017-12-18
Brief Title:
Clinical Trial to eLiminate HCV-infection in Treatment-naïve Renally Impaired EgyptiAn Patients on Renal Dialysis With Chronic Hepatitis C Genotype 4
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Single-site Open-label Non-comparator Clinical Trial to eLiminate HCV-infection in Treatment-naïve EgyptiAn Patients With End-stage Renal Disease on Renal Dialysis With Chronic Hepatitis C Genotype 4 Infection Using a 12-week Course of Once-daily Single Oral Tablet of Elbasvir 50mgGrazoprevir 100 mg
Status:
WITHDRAWN
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
HCV treatment expansion occurred in Egypt
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEAR-C4
Brief Summary:
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 ie 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 elbasvirgrazoprevir 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 elbasvirgrazoprevir 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 elbasvirgrazoprevir 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 elbasvirgrazoprevir 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
-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 ie 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 elbasvirgrazoprevir 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 elbasvirgrazoprevir 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 elbasvirgrazoprevir 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 elbasvirgrazoprevir 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None