Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-27 @ 6:10 AM
Study NCT ID:
NCT02973503
Status:
COMPLETED
Last Update Posted:
2020-10-01
First Post:
2016-10-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis
Status:
COMPLETED
Status Verified Date:
2020-09
Last Known Status:
None
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:
STREAGER
Brief Summary:
A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-severe fibrosis
The primary objectives of this study are as follows:
* To evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
* To evaluate the safety and tolerability of EBV/GZR treatment
The secondary objectives of this study are as follows:
* To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)
* To evaluate the proportion of subjects with virologic failure
* To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment.
* To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment
The primary objectives of this study are as follows:
* To evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
* To evaluate the safety and tolerability of EBV/GZR treatment
The secondary objectives of this study are as follows:
* To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of treatment (SVR4 and SVR24)
* To evaluate the proportion of subjects with virologic failure
* To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of treatment.
* To evaluate the emergence of viral resistance to EBV/GZR during treatment and after cessation of treatment
Detailed Description:
One hundred twenty treatment-naïve subjects with chronic HCV GT1b infection without cirrhosis will be enrolled.
There will be one treatment group with EBV/GZR (50/100 mg) once daily without regards to food for 8 weeks.
EBV/GZR is manufactured as a 50/100 mg tablet for oral administration. Subjects will take 1 tablet daily.
Screening assessments will be completed within 28 days of the Day 1 visit. The screening window can be extended to 42 days for subjects requiring a liver biopsy, or extenuating circumstances.
All subjects will complete the following study visits: Screening, Day 1, and on-treatment visits at the end of week 2, week 4 and week 8.
Post-treatment visits will occur at Weeks 4, 12, and 24 after last dose of study drug. All subjects will complete the posttreatment Week 4 and 12 visits. Subjects who achieve SVR12 (HCV RNA \< LLOQ at posttreatment Week12) will complete the posttreatment Week 24 visit.
Screening assessments will include physical examination, medical history, height, weight, vital signs, adverse events related to screening procedures, concomitant medications, safety laboratory tests (including hematology, chemistry, and coagulation), HCV RNA, serology (HCV, HBV), serology and/or antigen testing for HIV, HCV genotyping, hemoglobin A1c (HbA1c), assessment of the absence of cirrhosis or severe fibrosis (including Fibrotest® and Fibroscan®), serum β-human chorionic gonadotropin (β-hCG) (females of child-bearing potential only), urinalysis.
On-treatment assessments include adverse events (AEs), concomitant medications, study medication dispensation and pill count, physical examination, weight, vital signs, safety laboratory tests, HCV RNA, and urine pregnancy tests (females of child bearing potential only).
Post-treatment assessments include AEs, concomitant medications, vital signs, safety laboratory tests (including hematology, chemistry, and coagulation), HCV RNA, and urine pregnancy tests (females of child-bearing potential only).
There will be one treatment group with EBV/GZR (50/100 mg) once daily without regards to food for 8 weeks.
EBV/GZR is manufactured as a 50/100 mg tablet for oral administration. Subjects will take 1 tablet daily.
Screening assessments will be completed within 28 days of the Day 1 visit. The screening window can be extended to 42 days for subjects requiring a liver biopsy, or extenuating circumstances.
All subjects will complete the following study visits: Screening, Day 1, and on-treatment visits at the end of week 2, week 4 and week 8.
Post-treatment visits will occur at Weeks 4, 12, and 24 after last dose of study drug. All subjects will complete the posttreatment Week 4 and 12 visits. Subjects who achieve SVR12 (HCV RNA \< LLOQ at posttreatment Week12) will complete the posttreatment Week 24 visit.
Screening assessments will include physical examination, medical history, height, weight, vital signs, adverse events related to screening procedures, concomitant medications, safety laboratory tests (including hematology, chemistry, and coagulation), HCV RNA, serology (HCV, HBV), serology and/or antigen testing for HIV, HCV genotyping, hemoglobin A1c (HbA1c), assessment of the absence of cirrhosis or severe fibrosis (including Fibrotest® and Fibroscan®), serum β-human chorionic gonadotropin (β-hCG) (females of child-bearing potential only), urinalysis.
On-treatment assessments include adverse events (AEs), concomitant medications, study medication dispensation and pill count, physical examination, weight, vital signs, safety laboratory tests, HCV RNA, and urine pregnancy tests (females of child bearing potential only).
Post-treatment assessments include AEs, concomitant medications, vital signs, safety laboratory tests (including hematology, chemistry, and coagulation), HCV RNA, and urine pregnancy tests (females of child-bearing potential only).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2016-001363-37 | OTHER | 2016-001363-37 | View |