Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03144440 |
| Other study ID # |
CMC-16-0096-CTIL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2016 |
| Est. completion date |
January 1, 2021 |
Study information
| Verified date |
January 2023 |
| Source |
Carmel Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Primary objective:
1. To estimate the effectiveness of treatment with FDC of Zepatier with or without ribavirin
in Israeli patients with CHC and advanced fibrosis in real life setting.
Secondary objective:
1. To estimate the safety and tolerability of treatment with FDC of Zepatier with or without
ribavirin in real life setting in Israeli patients with CHC and advanced disease.
Hypotheses:
Effectiveness and tolerability of treatment with FDC of Zepatier with or without ribavirin in
Israeli patients with CHC and advanced fibrosis will be similar to that demonstrated in phase
3 clinical trials.
Description:
The following data will be collected:
Demographics information: age, gender, race, country of birth (COB). Data on liver and
virological characteristics: Hepatitis C virus(HCV) genotype, fibrosis stage (F0-4),
technology of fibrosis assessment (fibroscan, fibrotest, elastography, biopsy), , cirrhosis
(y/n), presence of portal hypertension: esophageal varices, ascites, hepatic encephalopathy,
history of decompensation, liver transplantation (y/n).
Previous anti-viral treatment: PR- Peg-Riba (relapse, partial/null responder, unknown
response), direct anti-viral agents (DDAs): Protease Inhibitors (PI) (Bocepravir,Telepravir,
Simepravir), Sofosbuvir (SOF), NS5A (Ledipasvir, Daclatasvir), NS5B.
Co-morbidities: BMI, Diabetes Mellitus, HIV-co infection, HBV-co infection, alcohol abuse,
CKD (Chronic kidney disease)/renal failure, cardiovascular disease, inherited blood
disorders, pre/post-transplant (liver/kidney) Concomitant medication (drug-drug
interactions): antiacids (Proton pump inhibitors,H2-blockers), statins,beta-blockers, oral
contraceptives, anti hypertensive, Anti retrovirals for HIV, etc.
Base line and end-of treatment parameters: White blood cells(WBC), Hemoglobin (HB),
Platelates (PLT), Alanine transferase (ALT), Aspartate transaminase (AST), Alpha phetoprotein
(ALP), Gamma glutamyl transferase (GGT), albumin, bilirubin, Protrombin time (PT)/INR, LDL-C,
IL28 (if available), Model for end stage liver disease (MELD) score, Child pugh (CPT)
score/class, viral load and virological response: HCV ribonucleic acid (RNA) at week 4 and 8
(if available), and sustained virological response (SVR) 12 and SVR24.
Data on virological breakthrough and relapse will be also collected and if possible to check
resistance associated variants (RAVs).
Data on treatment safety: any adverse event (AE), serious adverse event (SAE), AE which led
to early discontinuation of treatment; decompensation event (ascites, hepatic encephalopathy,
bleeding esophageal varices,) liver failure, liver transplantation and death.
Primary variable The proportion of patients achieving SVR12 (HCV RNA <15 IU/mL at follow-up
week 12; 12 weeks after the last actual dose of the Zepatier).
The Full Analysis Set will include all patients who received ≥1 dose of Zepatier.
Secondary variables
- Cirrhosis/Fibrosis stage (F3, F4). Cirrhosis defined by liver biopsy (Metavir F4);
transient elastography by Fibroscan tomography (TM) (>12.5 kPa); or FibroTest® or
FibroSure® (>0.75 with APRI >2).
- Previous HCV anti-viral treatment
- Co-morbidities and concomitant medication
- Laboratory abnormalities; baseline and end of treatment (EoT) parameters
- Serious and non-serious adverse events occurring at any time during the treatment
period, and other adverse events up until 14 days after cessation of treatment, will be
collected and analyzed.
