Hepatitis CNCT03144440
Real World Experience of Chronic Hepatitis C (CHC) Treatment in Israel
An observational study of Hepatitis C, run by Carmel Medical Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 13 Dec 2016to 1 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- Patients that treated with Zepatier after SVR results
Who cannot join
- NA
About this study
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
Primary objective:
- 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:
- 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.
Read the 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.
- Conditions
- Hepatitis C
- Keywords
- ZEPATIER
- Medical subject headings
- Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with sustained virological response at week 12 (SVR12) [ Time Frame (for each patient): 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
Measured: 12 weeks after the last dose of treatment
Secondary outcomes (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 .
Adverse event from the time when the decision is made to initiate treatment with Elbasvir/Grazoprevir until after the last dose
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start13 Dec 2016
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eli Zuckerman, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144440
- Sponsor's protocol ID
- CMC-16-0096-CTIL
- Status last verified
- Jan 2023
- First submitted
- 14 Mar 2017
- Last updated
- 31 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03144440
- Acronym / sponsor ID
- CMC-16-0096-CTIL
- Conditions
- Hepatitis C
- Keywords
- ZEPATIER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 13 Dec 2016 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
- 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:
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Patients that treated with Zepatier after SVR results
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Carmel Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.