Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-20 @ 12:31 PM
Study NCT ID:
NCT03222167
Status:
UNKNOWN
Last Update Posted:
2017-08-07
First Post:
2017-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b
Sponsor:
Institute Of Cardiology & Internal Diseases, Kazakhstan
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: