WithdrawnPhase 4

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

Stopped: HCV treatment expansion occurred in Egypt

Egypt0Started 2019-12-01

Plain-language 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), 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

Who can participate

Age range21 Years – 70 Years

SexALL

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Inclusion criteria

✓. Signed and dated informed consent obtained before undergoing any trial-related procedures
✓. Male and female patients; age between 21 and 70 years inclusive
✓. Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
✓. Treatment naïve - absence of prior failed treatment for HCV with Interferon plus ribavirin therapy or directly acting antivirals (treatment experienced)
✓. Detectable HCV viral load (quantitative)
✓. Liver cirrhosis subjects may be included but will be limited to those with compensated liver disease
✓. Chronic kidney disease with end-stage liver disease (defined as glomerular filtration rate \[eGFR\] \<=15 mL/min/1.73m2) on hemodialysis for at least 3 months, including individuals awaiting kidney transplant and those with failed kidney transplants but no longer on immunosuppressant therapy)
✓. Screening laboratory values within the defined protocol thresholds

Exclusion criteria

What they're measuring

SVR12

Timeframe: 24 weeks from treatment initiation date

Trial details

NCT IDNCT03381859

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-01

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