NCT03578640

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 6, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

2 years

First QC Date

June 6, 2018

Last Update Submit

November 18, 2020

Conditions

Hepatitis C, Chronic

Keywords

Hepatitis C VirusChronic Hepatitis CGenotype 4Treatment-naiveNon-cirrhotic

Outcome Measures

Primary Outcomes (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.)

    At 12 weeks after the end of intervention.

Secondary Outcomes (3)

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

    At 4 weeks after the end of intervention.

  • Serious and treatment-related adverse events.

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

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

    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

Study Arms (1)

Treatment arm

EXPERIMENTAL

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Interventions

Elbasvir, Grazoprevir 50-100Mg Oral TabletDRUG

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

Also known as: Elbasvir / Grazoprevir Oral Tablet (Zepatier)
Treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Fahad Medical City

Riyadh, 11525, Saudi Arabia

Location

Related Publications (5)

  • 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.

    RESULT

  • 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.

    RESULT

  • 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.

    PMID: 27770561RESULT

  • 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.

    PMID: 28193518RESULT

  • 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.

    PMID: 35142658DERIVED

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

elbasvirgrazoprevirTabletselbasvir-grazoprevir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Masking Details
Open-label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: An interventional, single-center, single-arm study among 30 patients who are treatment naïve, have no advanced fibrosis and mono-infected with HCV-GT4.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician, Department of Gastroenterology and Hepatology, Consultant Advanced Hepatology and Liver Transplantation, Principal Investigator of the ELEGANT-4 trial

Study Record Dates

First Submitted

June 6, 2018

First Posted

July 6, 2018

Study Start

July 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)