Hepatitis C, ChronicPhase 3NCT03186365
8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis
A Phase 3 study testing Zepatier Oral Product in people with Hepatitis C, Chronic, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Zepatier Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Jun 2017to 19 Sep 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
Read the 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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Zepatier Oral Product
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zepatier Oral ProductDrug
Also called Zepatier
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
| Study group | Role | What they receive |
|---|---|---|
| 8-week arm | Experimental | patients receiving 8 weeks of elbasvir 50 mg/grazoprevir (Zepatier Oral Product)100 mg daily Receives: Drug: Zepatier Oral Product |
| 12-week arm | Active comparator | patients receiving 12 weeks of elbasvir 50 mg/grazoprevir 100 mg (Zepatier Oral Product) daily Receives: Drug: Zepatier Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 5.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start12 Jun 2017
- Primary completion19 Sep 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Lung Yu, MD., PhD., Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186365
- Sponsor's protocol ID
- MISP-55740
- Status last verified
- Jan 2019
- First submitted
- 12 Jun 2017
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30957170
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03186365
- Acronym / sponsor ID
- MISP-55740
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-week arm | Experimental | Drug: Zepatier Oral Productpatients receiving 8 weeks of elbasvir 50 mg/grazoprevir (Zepatier Oral Product)100 mg daily |
| 12-week arm | Active comparator | Drug: Zepatier Oral Productpatients receiving 12 weeks of elbasvir 50 mg/grazoprevir 100 mg (Zepatier Oral Product) daily |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zepatier Oral ProductAlso: ZepatierGrazoprevir, 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 | Drug | 12-week arm, 8-week arm |
Primary outcome
the rate of subjects with undetectable HCV RNA 12 weeks post end-of-treatment
Time frame: through study completion, an average of 5.5 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
- Derived from this study: PubMed 30957170Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Lung Yu, MD., PhD. principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zepatier Oral Product in people with Hepatitis C, Chronic, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of subjects with undetectable HCV RNA 12 weeks post end-of-treatment (time frame: through study completion, an average of 5.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2019.