Metabolic Syndrome Clinical Trial
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
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.
60 treatment-naïve subjects with chronic hepatitis C genotype 1b infection associated with
metabolic syndrome (MS), with or without severe fibrosis/compensated cirrhosis will be
enrolled, males and females of 18-70 years of age.
Subjects will fulfill the following study visits: Day 1 (screening), Day 7, Week 2, Week 4,
Week 8, Week 12, Week 24, Week 36.
Eligibility criteria re-checked, informed consent signed and medical history will be gathered
on Day 1.
Treatment allocation and review study medication diary will be made on Day 7. Physical
Examinations will be fulfilled on Day 1, Day 7, Week 4 and Week 12. Subject Confirmation of
Birth Control and Review (Serious) Adverse Events will be made on every visit of subject.
Laboratory evaluations will include common blood analysis, urinalysis, biochemical blood
analysis, Thyroid-stimulating hormone (TSH) and Т4 free, antigen testings (aHBs, HBsAg,
HbeAg, aHDV, aHAV, aHEV, ANA, AMA, aHIV), HCV RNA (quantitative), HCV genotyping, Urine
Pregnancy Test (females of child bearing potential only), Transient elastography, Calculation
of APRI, Ultrasonography (of liver, gall bladder, spleen, pancreas), Upper GI Endoscopy.
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.
Primary objectives:
• To demonstrate efficacy of 12 weeks therapy with MK-5172 (grazoprevir) in combination with
MK-8742 (elbasvir) in treatment naïve patients with chronic hepatitis C (genotype 1b) with
metabolic syndrome compared to patients without metabolic syndrome, as assessed by the
proportion of subjects achieving SVR12, defined as HCV RNA < LLOQ (either TD[u] or TND) 12
weeks after the end of all study therapy.
Secondary objectives:
- To evaluate efficacy of 12 weeks therapy with MK-5172 in combination with MK-8742 in
treatment naïve patients with chronic hepatitis C (genotype 1b) with metabolic syndrome
compared to patients without metabolic syndrome, dependent on fibrosis stage, as
assessed by the proportion of subjects achieving SVR12, defined as HCV RNA < LLOQ
(either TD[u] or TND) 12 weeks after the end of all study therapy.
- To evaluate efficacy of MK-5172 in combination with MK-8742 in treatment naïve patients
with chronic hepatitis C (genotype 1) combined with metabolic syndrome dependent on
presence of the separate components of metabolic syndrome, as assessed by the proportion
of subjects achieving SVR24, defined as HCV RNA < LLOQ (either TD[u] or TND) 12 weeks
after the end of all study therapy.
- To evaluate efficacy of 12 weeks therapy with MK-5172 in combination with MK-8742 in
treatment naïve patients with chronic hepatitis C (genotype 1b) with metabolic syndrome
compared to patients without metabolic syndrome, as assessed by the proportion of TN
subjects achieving undetectable (TND) HCV RNA and HCV RNA < LLOQ at Week 2, 4, 8 and
Follow-Up Week 4 (SVR 4).
- To evaluate efficacy of 12 weeks therapy with MK-5172 in combination with MK-8742 in
treatment naïve patients with chronic hepatitis C (genotype 1b) with metabolic syndrome
compared to patients without metabolic syndrome, as assessed by the proportion of
subjects achieving SVR24, defined as HCV RNA < LLOQ (either TD[u] or TND) 24 weeks after
the end of all study therapy.
- To evaluate safety profile / adverse events of 12 weeks therapy with MK-5172 in
combination with MK-8742 in treatment naïve patients with chronic hepatitis C (genotype
1b) with metabolic syndrome
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