Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b
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|ClinicalTrials.gov Identifier: NCT03222167|
Recruitment Status : Not yet recruiting
First Posted : July 19, 2017
Last Update Posted : August 7, 2017
This is a multi-center, open-label trial of Elbasvir/ Grazoprevir 50/100 mg fixed dose combination 12 week treatment aimed to evaluate SVR12 in treatment naïve patients with chronic hepatitis C (genotype 1b) infection, associated with of metabolic syndrome. The study to be conducted in conformance with Good Clinical Practices.
A total of 60 subjects will be studied at 2 sites in the Republic of Kazakhstan.
Males and Females treatment naïve patients with CHC genotype 1b infection associated with metabolic syndrome (MS), 18-70 years of age, with or without severe fibrosis / compensated cirrhosis will be enrolled. SVR 12 (primary endpoint) will be evaluated. Patients will be stratified by fibrosis stage and presence of metabolic syndrome components. Interim Analysis will be performed in order to estimate viral kinetics, applicability of SVR4 and durability of SVR12 by evaluation of virologic response at week 4 and 8 of treatment and follow-up at week 4 (SVR 4) and 24 will be performed - this will be a descriptive summary only without hypothesis testing.
The main hypothesis is that 12-week therapy with MK-5172 in combination with MK-8742 for treatment-naïve patients with HCV genotype 1b with metabolic syndrome is not notably worse than the same course for treatment-naïve patients with HCV genotype 1b without metabolic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Genotype 1B Metabolic Syndrome Fibrosis, Liver Cirrhoses, Liver||Drug: Elbasvir/ Grazoprevir 50/100 mg fixed dose combination||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Multi-Center Single Arm Clinical Trial to Study the Efficacy and Safety of the Elbasvir/ Grazoprevir 50/100 mg Fixed Dose Combination Once Daily in Patients With Chronic HCV GT1b Infection Associated With Metabolic Syndrome|
|Anticipated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||August 2019|
U.S. FDA Resources
Experimental: Elbasvir/ Grazoprevir
Elbasvir/ Grazoprevir 50/100 mg fixed dose combination for 12 weeks treatment aimed to evaluate SVR12 in treatment naïve patients with chronic hepatitis C (genotype 1b) infection, associated with metabolic syndrome, with or without severe fibrosis / compensated cirrhosis.
Drug: Elbasvir/ Grazoprevir 50/100 mg fixed dose combination
Enrolled patients will be treated by Elbasvir/ Grazoprevir 50/100 mg fixed dose combination during 12 week. Followed-up on week 24. SVR12 will be evaluated.
- SVR12 evaluation [ Time Frame: 12 weeks after the end of all study therapy (treatment success). ]The main outcome is SVR12, defined as HCV RNA < LLOQ (either TD[u] or TND)
- Death/Lost [ Time Frame: 24 weeks ]Death or lost to follow-up before W24 will be considered as treatment failure (in full analysis set).
- HCV-RNA values [ Time Frame: 24 weeks ]Definitively missing plasma HCV-RNA values at W24 will be considered as treatment failure
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): NCT03222167
|National Research Institute of Cardiology and Internal Medicine||Not yet recruiting|
|Almaty, Kazakhstan, 050000|
|Contact: Alexandre V. Nersesov, MD, Prof. +7 701 799 82 12 email@example.com|
|Contact: Almagul Jumabayeva, MD, PhD +7 701 512 23 26 firstname.lastname@example.org|