NCT03144440

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

4.1 years

First QC Date

March 14, 2017

Last Update Submit

January 30, 2023

Conditions

Hepatitis C

Keywords

ZEPATIER

Outcome Measures

Primary Outcomes (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 ]

    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

    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 .

    24 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Patients that treated with Zepatier after SVR results

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Eli Zuckerman

Study Record Dates

First Submitted

March 14, 2017

First Posted

May 8, 2017

Study Start

December 13, 2016

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share