Chronic HCV InfectionPhase 3STREAGERNCT02973503
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
A Phase 3 study testing Elbasvir/Grazoprevir Fixed Dose Combination in people with Chronic HCV Infection, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic HCV Infection
- What is being tested?
- Elbasvir/Grazoprevir Fixed Dose Combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jan 2017to Apr 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 years
- Body Mass Index (BMI) ≥ 18 kg/m2
- HCV RNA ≥ 100 000 IU/mL at Screening
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy, only genotype 1b virus. (Positive for anti HCV antibody, HCV RNA, or an HCV genotype)
- Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
Show all 17Show fewer
- Non severe fibrosis (F<2) according to combination of this two tests :
- Fibroscan lower than 9.5kPa and Fibrotest lower than 0.59
- Females of childbearing potential (as defined in protocol Appendix 4) must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to enrollment
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use 2 effective method(s) of contraception from at least two weeks prior to Day 1 through 14 days after the last dose of study drugs.
- If acceptable by local regulatory agencies, methods of birth control allowed in the study are: intrauterine device (IUD), diaphragm with spermicide, hormonal contraceptives (e.g., birth control pills, transdermal patch, or injectables), contraceptive sponge, female condom, male condom with spermicide or vasectomy.
- Note: Periodic abstinence (e.g., abstinence only on certain calendar days, abstinence only during ovulation period, use of symptothermal methods, use of post-ovulation methods and withdrawal) are not acceptable methods of contraception.
- A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subjects who is not of reproductive potentials is defined as one who has either 1) reached natural menopause (defined as 12 months with no menses without an alternative medical cause), 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation.
- A male subject who is not of reproductive potential is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as: one who has undergone a successful vasectomy. A successful vasectomy is defined as: (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
- Lactating females must agree to discontinue nursing before starting study drug
- Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
- Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Who cannot join
- Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- Current or prior history of any of the following:
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
- Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- History of decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage)
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- Solid organ transplantation (including hematopoietic stem cell transplants) other than kidney, cornea and hair.
- Significant cardiac disease
- Unstable psychiatric condition including hospitalization, suicidal attempt, and/or a period of disability as a result of their psychiatric illness within 2 years prior to Screening
- Malignancy within the 5 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection (e.g., basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible
- Significant drug allergy (e.g., hepatotoxicity)
- Subject has the following laboratory parameters at Screening:
- ALT > 10 x the upper limit of normal (ULN)
- AST > 10 x ULN
- Direct bilirubin > 1.5 x ULN
- Platelets < 75,000/μL
- HbA1c > 8.5%
- Creatinine clearance < 50 mL/min as calculated by the Cockcroft-Gault equation
- Hemoglobin < 10 g/dL
- Albumin < 3 g/dL
- INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regime affecting INR
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Clinically-relevant alcohol or drug abuse within 12 months of Screening.
- Alcohol, intravenous drugs, inhalational (not including marijuana), psychotropic, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the screening visit, or if shorter, is judged by investigator to be capable of complying with study procedures
- receiving opiate agonist substitution therapy within 1 year of screening visit, or if shorter, is judged by investigator to be capable of complying with study procedures
- history of marijuana use if deemed excessive by a physician investigator or interferes with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must agree to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period
- A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator
- Use of any prohibited concomitant medication listed in Section 5.5 of this protocol within 2 weeks prior to day 1.
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient
- is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study. Collection of additional blood, urine, or tissue samples or additional data, beyond that specified in this protocol, is prohibited (other than that related to subject's medical care).
- (female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria); or male subject is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria).
- had a life-threatening SAE during the screening period. 2. is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
- has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
- NOTE: Subjects with history of acute non-HCV-related hepatitis, which resolved > 6 months before study entry, may be enrolled.
- For subjects diagnosed with diabetes mellitus, documented HbA1c >8.5% (to exclude uncontrolled diabetes).
- Has any of the following conditions:.
- Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
- Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
- Has exclusionary laboratory values as listed below (see Table 5 for unit conversions of some laboratory values specified below):
- Note: If any of the laboratory exclusion criteria below are met, the site may have the abnormal value retested one time.
- Table 5: Exclusionary laboratory values:
- Laboratory Assessment
- hemoglobin < LLN (lower limit of normal) of laboratory reference range
- neutrophils <1.5 x 103/μL (<1.2 x 103/μL for Blacks)
- platelets <75 x 103/μL
- direct bilirubin >1.5 x ULN
- Total Bilirubin >1.6 mg/dL unless history of Gilbert's disease. (If Gilbert's disease is the proposed etiology, this must be documented in the subject's chart)
- Serum Albumin < 3.0 g/dL (lower limit of normal) of laboratory reference range
- creatinine clearance <50 mL/min
- INR >1.5
- ALT >350
- AST >350
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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
Read the 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).
- Conditions
- Chronic HCV Infection
- Being tested
- Elbasvir/Grazoprevir Fixed Dose Combination
- Keywords
- Hepatitis C, Genotype 1B, Non Severe Fibrosis, Treatment Naïve, 8 Weeks of Treatment, Elbasvir/Grazoprevir Combination
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir/Grazoprevir Fixed Dose CombinationDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Elbasvir/Grazoprevir | Experimental | 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). Receives: Drug: Elbasvir/Grazoprevir Fixed Dose Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve as Measured by the Proportion of Subjects With Sustained Viral Response 12 Weeks After Cessation of Treatment (SVR 12).
Blood samples for HCV RNA determination were collected 12 weeks after cessation of treatment and analysed by local laboratories tests
Measured: at 12 weeks post-treatment
Secondary outcomes (7)
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Asthenia Reported
Asthenia was defined by abnormal physical weakness or lack of energy. Asthenia was monitored throughout the study and up to 24 weeks after planned end of treatment. An investigator who is a qualified physician evaluated all adverse events, causality and severity. Only grade 1 or 2 were reported. No grade 3. Grade was evaluated with table 9 of protocol.
Measured: Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Headache Reported
Headache is defined by pain felt in the cranial box. Headache was monitored throughout the study and up to 24 weeks after planned end of treatment. An investigator who is a qualified physician evaluated all adverse events, causality and severity. Only grade 1 or 2 were reported. No grade 3. grade was evaluated with table 9 of protocol.
Measured: between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Digestive Disorders Reported
Digestive disorders is defined by an acceleration, a slowing down or a disturbance of the intestinal transit with or without pain. Digestive disorders were monitored throughout the study and up to 24 weeks after planned end of treatment. An investigator who is a qualified physician evaluated digestive disorders causality and severity. Only grade 1 or 2 were reported. No grade 3. Grade was evaluated with table 9 of protocol.
Measured: Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Percentage of Subjects Who Attain SVR at 4 Weeks After Cessation of Treatment (SVR4)
blood samples were collected at 4 weeks after cessation of treatment and HCV RNA was measured using local laboratories tests
Measured: at 4 weeks after cessation of treatment
Percentage of Subjects Who Attain SVR 24 Weeks After Cessation of Treatment (SVR 24)
blood samples were collected at 24 weeks after cessation of treatment and HCV RNA was measured using local laboratories tests
Measured: at 24 weeks after cessation of treatment
Percentage of Subjects With Virologic Failure
patient with HCV RNA > low limit of quantification in two different consecutive blood samples were considered as relapser
Measured: at 12 weeks after cessation of treatment
Evaluation of the Emergence of Viral Resistance to EBV/GZR at 24 Weeks After Cessation of Treatment
Patients with HCV RNA> low limit of quantification in two consecutive blood samples were considered as relapsers.
Measured: at 24 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start11 Jan 2017
- Primary completion10 Nov 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic HCV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Armand ABERGEL, Principal investigator, University Hospital, Clermont-FerrandIsabelle FOUCHART-HUBERT, Principal investigator, University Hospital, AngersVincent DI MARTINO, Principal investigator, Centre Hospitalier Universitaire de BesanconVéronique LOUSTAUD RATTI, Principal investigator, CHU LIMOGESJérôme GOURNAY, Principal investigator, Nantes University HospitalTarik ASSELAH, Principal investigator, Hôpital BeaujonDidier SAMUEL, Principal investigator, Hôpital Paul BrousseDominique LARREY, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973503
- Sponsor's protocol ID
- CHU-0285
- Other IDs
- 2016-001363-37, 2016
- Acronym
- STREAGER
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2016
- Last updated
- 24 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Abergel A, Asselah T, Mallat A, Chanteranne B, Faure F, Larrey D, Gournay J, Loustaud-Ratti V, Di Martino V, Fouchard-Hubert I, Pol S, Bailly F, Samuel D, Tran A, Dodel M, Andant N, Lamblin G, Muti L, Reymond M, Teilhet C, Pereira B, Buchard B. Phase 3, Multicenter Open-Label study to investigate the efficacy of elbasvir and grazoprevir fixed-dose combination for 8 weeks in treatment-naive, HCV GT1b-infected patients, with non-severe fibrosis. Liver Int. 2020 Aug;40(8):1853-1859. doi: 10.1111/liv.14502. Epub 2020 Jun 1.
PubMed 32383275
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02973503
- Acronym / sponsor ID
- STREAGER / CHU-0285
- Conditions
- Chronic HCV Infection
- Keywords
- Hepatitis C, Genotype 1B, Non Severe Fibrosis, Treatment Naïve, 8 Weeks of Treatment, Elbasvir/Grazoprevir Combination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 10 Nov 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Posted 7 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elbasvir/Grazoprevir | Experimental | Drug: Elbasvir/Grazoprevir Fixed Dose Combinationevaluate 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 years
- Body Mass Index (BMI) ≥ 18 kg/m2
- HCV RNA ≥ 100 000 IU/mL at Screening
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy, only genotype 1b virus. (Positive for anti HCV antibody, HCV RNA, or an HCV genotype)
Key exclusion criteria (53 listed)
- Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- Current or prior history of any of the following:
- Subject has the following laboratory parameters at Screening:
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| Elbasvir/Grazoprevir Fixed Dose CombinationEvaluate 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). | Drug | Elbasvir/Grazoprevir |
Primary outcome
Evaluation of the Efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve as Measured by the Proportion of Subjects With Sustained Viral Response 12 Weeks After Cessation of Treatment (SVR 12).
Time frame: at 12 weeks post-treatment
Blood samples for HCV RNA determination were collected 12 weeks after cessation of treatment and analysed by local laboratories tests
7 secondary outcomes
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Asthenia Reported
Time frame: Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Headache Reported
Time frame: between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Evaluation of the Safety and Tolerability of EBV/GZR Treatment by Number of Patients With Treatment-related Digestive Disorders Reported
Time frame: Between the first day of treatment to 24 weeks after the end of treatment, an average of 32 weeks
Percentage of Subjects Who Attain SVR at 4 Weeks After Cessation of Treatment (SVR4)
Time frame: at 4 weeks after cessation of treatment
Percentage of Subjects Who Attain SVR 24 Weeks After Cessation of Treatment (SVR 24)
Time frame: at 24 weeks after cessation of treatment
Percentage of Subjects With Virologic Failure
Time frame: at 12 weeks after cessation of treatment
Evaluation of the Emergence of Viral Resistance to EBV/GZR at 24 Weeks After Cessation of Treatment
Time frame: at 24 weeks after end of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 32383275Abergel A, Asselah T, Mallat A, Chanteranne B, Faure F, Larrey D, Gournay J, Loustaud-Ratti V, Di Martino V, Fouchard-Hubert I, Pol S, Bailly F, Samuel D, Tran A, Dodel M, Andant N, Lamblin G, Muti L, Reymond M, Teilhet C, Pereira B, Buchard B. Phase 3, Multicenter Open-Label study to investigate the efficacy of elbasvir and grazoprevir fixed-dose combination for 8 weeks in treatment-naive, HCV GT1b-infected patients, with non-severe fibrosis. Liver Int. 2020 Aug;40(8):1853-1859. doi: 10.1111/liv.14502. Epub 2020 Jun 1.
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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.
Armand ABERGEL principal investigator
University Hospital, Clermont-Ferrand
Isabelle FOUCHART-HUBERT principal investigator
University Hospital, Angers
Vincent DI MARTINO principal investigator
Centre Hospitalier Universitaire de Besancon
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 Elbasvir/Grazoprevir Fixed Dose Combination in people with Chronic HCV Infection, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 17 inclusion and 53 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 24 Aug 2026. 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 France. 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?
Yes. Results are posted in the registry (first posted 7 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of the Efficacy of of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve as Measured by the Proportion of Subjects With Sustained Viral Response 12 Weeks After Cessation of Treatment (SVR 12). (time frame: at 12 weeks post-treatment). 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 NCT02973503, 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 24 Aug 2026.