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Trial record 59 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

Real World Experience of Chronic Hepatitis C (CHC) Treatment in Israel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03144440
Recruitment Status : Active, not recruiting
First Posted : May 8, 2017
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Zuckerman, Carmel Medical Center

Brief 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.


Condition or disease
Hepatitis C

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Real World Experience of Chronic Hepatitis C Treatment in Israeli Patients With Advanced Liver Fibrosis With Fixed Dose Combination (FDC) Grazoprevir (100 mg)/Elbasvir (50mg) (Zepatier) ± Ribavirin: A Retrospective Multicenter Cohort Study
Actual Study Start Date : December 13, 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Percentage of participants with sustained virological response at week 12 (SVR12) [ Time Frame (for each patient): 12 weeks after the last dose of treatment ] [ Time Frame: 12 weeks after the last dose of treatment ]
    SVR12 is defined as hepatitis c virus ribonucleic acid (HCV RNA) levels less than the lower limit of quantification 12 weeks after the last dose of treatment


Secondary Outcome Measures :
  1. Safety of Elbasvir/Grazoprevir treatment against HCV infection in real-life conditions is reflected as the number of patients with clinical and biological adverse events occurring during the treatment . [ Time Frame: 24 weeks ]
    Adverse event from the time when the decision is made to initiate treatment with Elbasvir/Grazoprevir until after the last dose



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Data collection from electronic patients' files from the different medical centers participating in the study will be performed after completion of treatment and follow-up period of up to 24 weeks post treatment (SVR).

Data will be collected every 4 months (3 times a year) and analyzed in one center (Carmel Medical Center, Haifa, Israel).

Study interim report will be provided twice per year (middle and end of each year)

Criteria

Inclusion Criteria:

  • Patients that treated with Zepatier after SVR results

Exclusion Criteria:

  • NA

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Responsible Party: Eli Zuckerman, Prof. Eli Zuckerman, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT03144440    
Other Study ID Numbers: CMC-16-0096-CTIL
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Zuckerman, Carmel Medical Center:
ZEPATIER
Additional relevant MeSH terms:
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Elbasvir-grazoprevir drug combination
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Antiviral Agents
Anti-Infective Agents