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Hepatitis C, ChronicPhase 3ELEGANT-4NCT03578640

Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4

A Phase 3 study testing Elbasvir, Grazoprevir 50-100Mg Oral Tablet in people with Hepatitis C, Chronic, run by King Fahad Medical City at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the safety and efficacy of a daily, fixed-dose, 8-week course combination of Elbasvir/Grazoprevir in treatment-naïve, non-cirrhotic patients who are mono-infected with hepatitis C, genotype 4. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Elbasvir, Grazoprevir 50-100Mg Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSaudi Arabia
Study dates
1 Jul 2018to 30 Jun 2020
Phase
Phase 3
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age above 18 years.
  • Chronically infected with HCV genotype 4.
  • Treatment naïve.
  • No advanced fibrosis. Defined by the absence of clinical, radiological and laboratory signs of cirrhosis, and fibrosis assessment consistent with fibrosis stage (Metavir F2) or less by liver biopsy or transient elastography.
  • Not expected to leave the country for six months after the end of the intervention.

Who cannot join

  • Incapability of providing an informed consent to participate in the study.
  • Advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4).
  • HIV or HBV co-infection
  • Organ transplant recipients.
  • Type 2 or 3 cryoglobulinemia with end-organ manifestations.
  • Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis
Show all 10Show fewer
  • Patients with a higher risk of transmitting the disease (Dialysis patients, incarcerated individuals, and intravenous drug abusers).
  • The use of any medication that has major interactions with Elbasvir or Grazoprevir as defined by the University of Liverpool drug interaction database, and cannot be discontinued or replaced with other alternatives.
  • Pregnancy.
  • History of hepatocellular carcinoma.

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • King Fahad Medical City

    Riyadh, 11525

Other trials in Saudi Arabia

About this study

Official title: The Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, Non-Cirrhotic, HCV GT4-Infected Patients: A Single-Center, Single-Arm, Open-Label, Phase III Trial

To evaluate the safety and efficacy of a daily, fixed-dose, 8-week course combination of Elbasvir/Grazoprevir in treatment-naïve, non-cirrhotic patients who are mono-infected with hepatitis C, genotype 4.

Read the detailed description

The treatment of hepatitis C has gone through significant advances in the last few years with the development of direct-acting antivirals "DAAs." Since 2013, many DAAs have been approved for the treatment of HCV with excellent efficacy and safety profiles. The major hurdle in treating patients on a large scale is the high cost of the current treatment regimens. Multiple approaches have been proposed, among them, a shortened treatment regimen of 6 to 8 weeks rather than the standard 12-week-regimen. The strategy of shortening the treatment will help in reducing the cost by 33% to 50%. Thus, it will increase the availability of the treatment to more patients.

Zepatier is a combination drug of Elbasvir (EBR), an NS5A inhibitor, and Grazoprevir (GZR), a potent NS3/4A inhibitor. This study is being proposed to address two main issues. First, collecting information on the safety and efficacy of a shortened course of zepatier (8 weeks instead of the standard 12 weeks) in patients who are treatment-naïve, non-cirrhotic and mono-infected with HCV. Second, to investigate whether this course provides similar clinical outcomes to the standard regimen in HCV-Genotype 4, which is the most common genotype in Saudi Arabia.

Being tested
Elbasvir, Grazoprevir 50-100Mg Oral Tablet
Keywords
Hepatitis C Virus, Chronic Hepatitis C, Genotype 4, Treatment-naive, Non-cirrhotic
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elbasvir, Grazoprevir 50-100Mg Oral TabletDrug

    Also called Elbasvir / Grazoprevir Oral Tablet (Zepatier)

    Daily, fixed-dose combination of Elbasvir 50 mg and Grazoprevir 100 mg given in a single oral tablet for 8 weeks.

Study groups in NCT03578640
Study groupRoleWhat they receive
Treatment armExperimentalElbasvir, Grazoprevir 50-100Mg Oral Tablet
Receives: Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sustained virologic response at 12 weeks after the end of intervention (SVR-12).

    Viral RNA below the level of detection at 12 weeks after the end of the intervention.

    (Hepatitis C viral load evaluated by polymerase chain reaction (PCR) with a cutoff of 20 IU/mL for detectability.)

    Measured: At 12 weeks after the end of intervention.

Secondary outcomes (3)

  1. Sustained virological response at 4 weeks after the end of intervention (SVR-4).

    Hepatitis C viral RNA below the level of detection at 4 weeks after the end of the intervention.

    Measured: At 4 weeks after the end of intervention.

  2. Serious and treatment-related adverse events.

    Number of patients with serious and treatment-related adverse events based on the common terminology criteria (CTCAE 4.03), or death during the follow-up period.

    Measured: From the first day of intervention until the end of week 4 after the intervention is finished.

  3. Changes in the quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)

    To assess this outcome, a self-administered questionnaire called the "Hepatitis Quality of Life Questionnaire" (HQLQ) will be used. The HQLQ is composed of 7 domains; the physical and mental components (PCS and MCS, respectively), a self-evaluated health transition item (SET), and four hepatitis-related items. The latter include general health distress (HD), psychological well-being (PWB), hepatitis-specific functional limitations (HLIM), and hepatitis-specific health distress (HHD) sub-scales. Higher numbers on each component/scale represent better results (e.g., better physical, emotional, and psychological functioning, and little to no limitations in these aspects). Higher scores on the self-evaluated transition item, however, represent less favorable results.

    These assessments will take place over three occasions. The first will be upon initiating the treatment, the second will be during/by the end of treatment, and the last will take place 12 weeks after the end of treatment.

    Measured: Quality of life evaluations will take place over three occasions. The first will be at baseline (upon treatment initiation), the second will be during treatment/at the end of treatment, and the last will be 12 weeks after the end of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2018
  2. Study start1 Jul 2018
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
An interventional, single-center, single-arm study among 30 patients who are treatment naïve, have no advanced fibrosis and mono-infected with HCV-GT4.
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03578640
Sponsor's protocol ID
18-226
Acronym
ELEGANT-4
Status last verified
Nov 2020
First submitted
6 Jun 2018
Last updated
20 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Serfaty L, Zeuzem S, Vierling JM, et al. High efficacy of the combination HCV regimen grazoprevir and elbasvir for 8 or 12 weeks with or without ribavirin in treatment-naive, noncirrhotic HCV GT1b-infected patients: an integrated analysis. Program and abstracts of the 2015 Annual Meeting of the American Association for the Study of Liver Diseases; November 13-17, 2015; San Francisco, California. Abstract 701.

  • STREAGER Interim Analysis: High Rate of SVR With 8 Weeks of Elbasvir/Grazoprevir in Treatment-Naive Patients With Genotype 1b HCV Infection and F0-F2 Fibrosis; 2017 Annual Meeting of the American Association for the Study of Liver Diseases; Washington DC; Posted online October 27, 2017.

  • Lawitz E, Poordad F, Gutierrez JA, Wells JT, Landaverde CE, Evans B, Howe A, Huang HC, Li JJ, Hwang P, Dutko FJ, Robertson M, Wahl J, Barr E, Haber B. Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology. 2017 Feb;65(2):439-450. doi: 10.1002/hep.28877. Epub 2016 Dec 19.

    PubMed 27770561

  • Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.

    PubMed 28193518

  • AlEid A, Al Balkhi A, Qutub A, Abbarh S, AlLehibi A, Almtawa A, Al Otaibi N, AlGhamdi A, AlGhamdi A, Alamr A, Ahmad S, Al Sayari K, Al Ibrahim B, AlKhathlan A. The efficacy of Elbasvir/Grazoprevir fixed-dose combination for 8 weeks in HCV treatment and health-related quality of life (HRQoL) in treatment-naive, non-cirrhotic, genotype 4-infected patients (ELEGANT-4): A single-center, single-arm, open-label, phase 3 trial. Saudi J Gastroenterol. 2022 May-Jun;28(3):225-232. doi: 10.4103/sjg.sjg_374_21.

    PubMed 35142658

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elbasvir, Grazoprevir 50-100Mg Oral Tablet in people with Hepatitis C, Chronic, run by King Fahad Medical City at 1 site in Saudi Arabia.

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 5 inclusion and 10 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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Sustained virologic response at 12 weeks after the end of intervention (SVR-12). (time frame: At 12 weeks after the end of intervention.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03578640, which also lists 5 linked publications.

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 20 Nov 2020.

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