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8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

Zepatier Oral Product

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Treatment naïve, HCV genotype 1b patients
History of chronic HCV infection > 6 months
Aged at least 20 years
HCV RNA of 10,000 IU/mL or greater
Fibroscan examination < 9.5 Kpa
Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs
Female patients with childbearing potential must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment till end of follow up.
A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can be used after end of treatment. All men with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and till end of follow up
Ability to participate and willingness to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

Prior experience of IFN or direct antiviral agents (DAA)
Hepatitis B virus or HIV co-infection.
Patients with experience of ascites, esophageal varices, or other evidence of hepatic decompensation, and/or hepatocellular carcinoma.
History of organ transplantation, except cornea transplantation.
Hemoglobulin concentration < 11 mg/dl
Platelet count < 75,000/mm3
Albumin < 3 mg/dL
History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin)
Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition.
Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's disease.
Pregnant or lactating women.

Sites / Locations

Kaohsiung Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

8-week arm

12-week arm

Arm Description

patients receiving 8 weeks of elbasvir 50 mg/grazoprevir (Zepatier Oral Product)100 mg daily

patients receiving 12 weeks of elbasvir 50 mg/grazoprevir 100 mg (Zepatier Oral Product) daily

Outcomes

Primary Outcome Measures

the rate of subjects with undetectable HCV RNA 12 weeks post end-of-treatment

to determine the treatment efficacy (sustained virological response 12 weeks after treatment, SVR12) of 8 weeks of grazoprevir/elbasvir for naïve HCV G1b patients with mild fibrosis, compared to the SVR12 of a universal 12-week grazoprevir/elbasvir for naïve HCV G1b patients with mild fibrosis (Fibrosis score 0-2

Secondary Outcome Measures

Full Information

NCT ID

NCT03186365

First Posted

June 12, 2017

Last Updated

January 8, 2019

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03186365

Brief Title

8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis

Official Title

Efficacy of 8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve Chronic Hepatitis C Genotype 1b Patients With Mild Fibrosis: an Open-label, Randomized, Active Control Trial (EGALITE)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

June 12, 2017 (Actual)

Primary Completion Date

September 19, 2018 (Actual)

Study Completion Date

September 19, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Grazoprevir plus elbasvir 12 to 16 weeks is now approved for chronic hepatitis C (CHC) genotype 1, 4, or 6 infection regardless liver disease severity. The current study aims to explore the efficacy and safety of 8-week grazoprevir/elbasvir in HCV-1b patients with mild liver fibrosis

Detailed Description

Grazoprevir, an HCV nonstructural protein 3/4A (NS3/4A) inhibitor 100 mg, plus elbasvir, an HCV NS5A inhibitor 50 mg fixed dose combination, Zepatier, achieved high SVR12 rates of > 95 % in treatment-naïve, experienced cirrhotic and non-cirrhotic patients with genotype 1, 4, or 6 infection. Zepatier, 12 to 16 weeks, was approved for the treatment of HCV genotype 1 and 4 in Taiwan in December, 2016. An SVR rate of 93 % was demonstrated in treatment-naive, non-cirrhotic (F0-F3) GT1b-infected patients who received 8 weeks of grazoprevir/elbasvir with or without ribavirin in the pooled analysis of C-WORTHY (PN035) and C-EDGE treatment-naive (PN060) trials. Furthermore, truncated treatment period of 8-week grazoprevir/elbasvir could achieve an even higher SVR rate at > 98% for naive HCV G1b patients with mild fibrosis (Fibrosis score 0-2). The study aims to evaluate the efficacy of 8-week regimen with grazoprevir/elbasvir on naïve, HCV G1b patients with mild fibrosis by a randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

8-week arm

Arm Type

Experimental

Arm Description

patients receiving 8 weeks of elbasvir 50 mg/grazoprevir (Zepatier Oral Product)100 mg daily

Arm Title

12-week arm

Arm Type

Active Comparator

Arm Description

patients receiving 12 weeks of elbasvir 50 mg/grazoprevir 100 mg (Zepatier Oral Product) daily

Intervention Type

Drug

Intervention Name(s)

Zepatier Oral Product

Other Intervention Name(s)

Zepatier

Intervention Description

Grazoprevir, an HCV nonstructural protein 3/4A (NS3/4A) inhibitor 100 mg, plus elbasvir, an HCV NS5A inhibitor 50 mg fixed dose combination,Zepatier Oral Product, will be prescribed for 8-12 weeks

Primary Outcome Measure Information:

Title

the rate of subjects with undetectable HCV RNA 12 weeks post end-of-treatment

Description

Time Frame

through study completion, an average of 5.5 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Treatment naïve, HCV genotype 1b patients History of chronic HCV infection > 6 months Aged at least 20 years HCV RNA of 10,000 IU/mL or greater Fibroscan examination < 9.5 Kpa Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs Female patients with childbearing potential must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment till end of follow up. A hormonal contraception (in lieu of non-hormonal) plus a physical barrier method can be used after end of treatment. All men with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and till end of follow up Ability to participate and willingness to give written informed consent and to comply with the study restrictions. Exclusion Criteria: Prior experience of IFN or direct antiviral agents (DAA) Hepatitis B virus or HIV co-infection. Patients with experience of ascites, esophageal varices, or other evidence of hepatic decompensation, and/or hepatocellular carcinoma. History of organ transplantation, except cornea transplantation. Hemoglobulin concentration < 11 mg/dl Platelet count < 75,000/mm3 Albumin < 3 mg/dL History of active malignancy within the last 5 years, with the exception of localized or in situ carcinoma (e.g., basal or squamous cell carcinoma of the skin) Poorly controlled diabetes (Hemoglobin A1c value ≥ 8.5%) and endocrine condition. Total bilirubin >2 mg/dL, unless subject has a documented history of Gilbert's disease. Pregnant or lactating women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming-Lung Yu, MD., PhD.

Organizational Affiliation

Kaohsiung Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaohsiung Medical University Hospital

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30957170

Citation

Huang CF, Hung CH, Cheng PN, Bair MJ, Huang YH, Kao JH, Hsu SJ, Lee PL, Chen JJ, Chien RN, Peng CY, Lin CY, Hsieh TY, Cheng CH, Dai CY, Huang JF, Chuang WL, Yu ML. An Open-Label, Randomized, Active-Controlled Trial of 8 Versus 12 Weeks of Elbasvir/Grazoprevir for Treatment-Naive Patients With Chronic Hepatitis C Genotype 1b Infection and Mild Fibrosis (EGALITE Study): Impact of Baseline Viral Loads and NS5A Resistance-Associated Substitutions. J Infect Dis. 2019 Jul 19;220(4):557-566. doi: 10.1093/infdis/jiz154.

Results Reference

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8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis

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