Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4 (ELEGANT-4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03578640|
Recruitment Status : Not yet recruiting
First Posted : July 6, 2018
Last Update Posted : July 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis C, Chronic||Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|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|
|Estimated Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||February 28, 2019|
Experimental: Treatment arm
Elbasvir, Grazoprevir 50-100Mg Oral Tablet
Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet
Daily, fixed-dose combination of Elbasvir 50 mg and Grazoprevir 100 mg given in a single oral tablet for 8 weeks.
Other Name: Elbasvir / Grazoprevir Oral Tablet (Zepatier)
- Sustained virologic response at 12 weeks after the end of intervention (SVR-12). [ Time Frame: At 12 weeks after the end of intervention. ]
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.)
- Sustained virological response at 4 weeks after the end of intervention (SVR-4). [ Time Frame: At 4 weeks after the end of intervention. ]Hepatitis C viral RNA below the level of detection at 4 weeks after the end of the intervention.
- Serious and treatment-related adverse events. [ Time Frame: From the first day of intervention until the end of week 4 after the intervention is finished. ]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.
- Prevalence of resistance associated substitutes (RASs) [ Time Frame: At 12 weeks after the end of intervention. ]The prevalence of resistance associated substitutes (RASs) at baseline in patients who fail to achieve the primary endpoint. This will be done in a retrospective manner as blood samples will be collected in a blood biobank prior to the therapy.
- Prevalence of treatment emerging resistance associated variants (RAVs) [ Time Frame: At 12 weeks after the end of intervention. ]The prevalence of treatment emerging resistance associated variants (RAVs) in patients who fail to achieve the primary end point.
- Changes in the quality of life: Hepatitis Quality of Life Questionnaire (HQLQ) [ Time Frame: Quality of life assessment of the patient's will take place over three occasions. The 1st will be a baseline assessment upon initiating the treatment, the 2nd will be at the last day of treatment, and the last will be 24 weeks after the end of treatment. ]
To assess the patient's quality of life, we will be using a self-administered questionnaire called the "Hepatitis Quality of Life Questionnaire" (HQLQ). The questionnaire has questions that aim to evaluate how well the patient can do his/her usual activities. Overall, the higher the score, the better the quality of life.
Assessment of the patient's quality of life will take place over three occasions. The first will be a baseline assessment upon initiating the treatment, the second will be at the last day of treatment (in other words, when the patient finishes the 8-week course), and the last will take place 24 weeks after the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03578640
|Contact: Ahmad A AlEid, MBBS||+966 11 2889999 ext email@example.com|
|Contact: Abdullah A Al Khathlan, MBBS||+966 11 2889999 ext 27602||aKhathlan@kfmc.med.sa|
|King Fahad Medical City|
|Riyadh, Saudi Arabia, 11525|
|Contact: Omar H Kasule, PhD +966 11 288 9999 ext 26913 firstname.lastname@example.org|
|Contact: Isamme N AlFayyad, MA BioEthics +966 11 288 9999 ext 10848 email@example.com|
|Principal Investigator: Ahmad A AlEid, Consultant|
|Sub-Investigator: Abdullah A AlKhathlan, Consultant|
|Sub-Investigator: Areej N Al Balkhi, MBBS|
|Sub-Investigator: Adel Al Qutub, Consultant|