8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis

January 8, 2019 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital

Efficacy of 8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve Chronic Hepatitis C Genotype 1b Patients With Mild Fibrosis: an Open-label, Randomized, Active Control Trial (EGALITE)

Grazoprevir plus elbasvir 12 to 16 weeks is now approved for chronic hepatitis C (CHC) genotype 1, 4, or 6 infection regardless liver disease severity. The current study aims to explore the efficacy and safety of 8-week grazoprevir/elbasvir in HCV-1b patients with mild liver fibrosis

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Grazoprevir, an HCV nonstructural protein 3/4A (NS3/4A) inhibitor 100 mg, plus elbasvir, an HCV NS5A inhibitor 50 mg fixed dose combination, Zepatier, achieved high SVR12 rates of > 95 % in treatment-naïve, experienced cirrhotic and non-cirrhotic patients with genotype 1, 4, or 6 infection. Zepatier, 12 to 16 weeks, was approved for the treatment of HCV genotype 1 and 4 in Taiwan in December, 2016. An SVR rate of 93 % was demonstrated in treatment-naive, non-cirrhotic (F0-F3) GT1b-infected patients who received 8 weeks of grazoprevir/elbasvir with or without ribavirin in the pooled analysis of C-WORTHY (PN035) and C-EDGE treatment-naive (PN060) trials. Furthermore, truncated treatment period of 8-week grazoprevir/elbasvir could achieve an even higher SVR rate at > 98% for naive HCV G1b patients with mild fibrosis (Fibrosis score 0-2). The study aims to evaluate the efficacy of 8-week regimen with grazoprevir/elbasvir on naïve, HCV G1b patients with mild fibrosis by a randomized clinical trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
82

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Treatment naïve, HCV genotype 1b patients
  • History of chronic HCV infection > 6 months
  • Aged at least 20 years
  • HCV RNA of 10,000 IU/mL or greater
  • Fibroscan examination < 9.5 Kpa
  • Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
  • Female patients with childbearing potential must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment till end of follow up.
  • A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can be used after end of treatment. All men with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and till end of follow up
  • Ability to participate and willingness to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

  • Prior experience of IFN or direct antiviral agents (DAA)
  • Hepatitis B virus or HIV co-infection.
  • Patients with experience of ascites, esophageal varices, or other evidence of hepatic decompensation, and/or hepatocellular carcinoma.
  • History of organ transplantation, except cornea transplantation.
  • Hemoglobulin concentration < 11 mg/dl
  • Platelet count < 75,000/mm3
  • Albumin < 3 mg/dL
  • History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)
  • Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition.
  • Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's disease.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 8-week arm
patients receiving 8 weeks of elbasvir 50 mg/grazoprevir (Zepatier Oral Product)100 mg daily
Drug: Zepatier Oral Product
Grazoprevir, an HCV nonstructural protein 3/4A (NS3/4A) inhibitor 100 mg, plus elbasvir, an HCV NS5A inhibitor 50 mg fixed dose combination,Zepatier Oral Product, will be prescribed for 8-12 weeks
Other Names:
  • Zepatier
ACTIVE_COMPARATOR: 12-week arm
patients receiving 12 weeks of elbasvir 50 mg/grazoprevir 100 mg (Zepatier Oral Product) daily
Drug: Zepatier Oral Product
Grazoprevir, an HCV nonstructural protein 3/4A (NS3/4A) inhibitor 100 mg, plus elbasvir, an HCV NS5A inhibitor 50 mg fixed dose combination,Zepatier Oral Product, will be prescribed for 8-12 weeks
Other Names:
  • Zepatier

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the rate of subjects with undetectable HCV RNA 12 weeks post end-of-treatment
Time Frame: through study completion, an average of 5.5 months
to determine the treatment efficacy (sustained virological response 12 weeks after treatment, SVR12) of 8 weeks of grazoprevir/elbasvir for naïve HCV G1b patients with mild fibrosis, compared to the SVR12 of a universal 12-week grazoprevir/elbasvir for naïve HCV G1b patients with mild fibrosis (Fibrosis score 0-2
through study completion, an average of 5.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Medical University Chung-Ho Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 19, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MISP-55740

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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