Chronic Hepatitis C Genotype 1BPhase 3NCT03222167
Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b
A Phase 3 study testing Elbasvir/ Grazoprevir 50/100 mg fixed dose combination in people with Chronic Hepatitis C Genotype 1B and Metabolic Syndrome, run by Institute Of Cardiology & Internal Diseases, Kazakhstan at 1 site in Kazakhstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Genotype 1B, Metabolic Syndrome, Fibrosis, Liver
- What is being tested?
- Elbasvir/ Grazoprevir 50/100 mg fixed dose combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKazakhstan
- Study dates
- Oct 2017to Aug 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18-70 years of age on a day of signing of informed consent.
- Have ≤40 kg/m2.
- Have HCV RNA ≥ 10,000 IU/mL at the time of screening.
- Have documented chronic HCV GT1b (with no evidence of non-typeable or mixed genotype) infection (positive for anti-HCV antibody, HCV RNA, or HCV GT1b at least 6 months before screening).
- Have liver disease staging assessment by means of liver biopsy performed within 12 calendar months prior to Day 1 of this study or Fibroscan performed within 6 calendar months prior to Day 1 of this study (cut-off of 12.5 kPa has a positive predictive value of 90% and a sensitivity of 95% for ≥F3).
- Be HIV and HBV negative.
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- Be naïve to all anti-HCV treatment.
- Have provided written informed consent for the trial.
- Be diagnosed with metabolic syndrome (according to guidelines from the National Heart, Lung, and Blood Institute (NHLBI) and the American Heart Association (AHA)), i.e. have central obesity (defined as waist circumference in Asian males >94 cm, in Caucasian males >90 cm, in females > 80 cm) combined with at least any of two of the following factors: (1) raised triglycerides ≥150 mg/dL (1.7 mmol/L) or specific treatment for this lipid abnormality; (2) reduced HDL cholesterol < 40 mg/dL (1.03 mmol/L) in males or < 50 mg/dL (1.29 mmol/L) in females or specific treatment for this lipid abnormality; (3) raised blood pressure - systolic BP ≥130 or diastolic BP ≥ 85 mm Hg or treatment of previously diagnosed hypertension; (4) raised fasting plasma glucose (FPG) ≥100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes.
- Reproductive potential patient agrees to avoid becoming pregnant or impregnating a partner until at least 6 months after the last dose of medication.
Who cannot join
- Is below 18 years of age.
- Has not signed Informed Consent Document.
- Has HCV genotype other than genotype 1b.
- Has BMI > 40 kg/m2.
- Has history of clinically significant psychiatric disorder which in the opinion of the investigator, would interfere with the study procedures and compliance.
- Has received Peg/RBV, Telaprevir, or Boceprevir, or Sofosbuvir, or any other oral anti-HCV treatment/ combinations
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- Has documented portal hypertension and hepatic decompensation (Child-Pugh B or C, esophageal varices, ascites, elevated bilirubin, jaundice, splenomegaly, hepatic encephalopathy, albumin below 3 g/dl; platelet count < 75 000, INR<1.7), history of liver decompensation.
- Has history of liver or other organ transplant.
- Has autoimmune hepatitis.
- Has ALT > 10 x ULN.
- Is co-infected with hepatitis B virus (e.g., HBsAg positive) and HIV.
- Has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC (if liver imaging within 6 months of Day1 is not available, imaging is required during the screening).
- Has a clinically-relevant drug or alcohol abuse within 12 months of screening.
- Has decompensated DM with HbA1 >12%.
- Has a medical/surgical condition that may result in a need for hospitalization during the period of the study.
- Is a female who is pregnant or breast-feeding, or expecting to become pregnant and continue throughout treatment and follow up, OR male who plan to impregnate or has a female sexual partner of childbearing potential, or pregnant, or unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment and follow-up.
- Is currently participating or has participated in a study with an investigational compound within 30 days
- Is taking or plan to take any of the prohibited medications or herbal supplements: co-administration with the following drugs: Didanosine, Nafcillin, Rifampin Phenytoin, Bosentan, Modafinil, Phenobarbital, Carbamazepine, St. John's Wort (Hypericum perforatum), Glibenclamid, Glyburide, Gemfibrozil, Eltrombopag, Lapatinib, Efavirenz, Atazanavir, Darunavir, Lopinavir, Saquinavir, Tipranavir, Cyclosporine, Simvastatin, Fluvastatin, Rosuvastatin greater than 10 mg dose, Atorvastatine greater than 10 mg dose, hepatotoxic drugs. Any condition that requires administration of systemic corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the study.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
National Research Institute of Cardiology and Internal Medicine
Almaty, 050000
Alexandre V. Nersesov, MD, Prof., +7 701 799 82 12, alexander.nersesov@gmail.com
Almagul Jumabayeva, MD, PhD, +7 701 512 23 26, almusa010@mail.ru
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Elbasvir/ Grazoprevir 50/100 mg fixed dose combination
- Keywords
- Elbasvir, Grazoprevir, SVR12, hepatitis C, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Liver Cirrhosis, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir/ Grazoprevir 50/100 mg fixed dose combinationDrug
Enrolled patients will be treated by Elbasvir/ Grazoprevir 50/100 mg fixed dose combination during 12 week. Followed-up on week 24. SVR12 will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Elbasvir/ Grazoprevir | Experimental | Elbasvir/ Grazoprevir 50/100 mg fixed dose combination for 12 weeks treatment aimed to evaluate SVR12 in treatment naïve patients with chronic hepatitis C (genotype 1b) infection, associated with metabolic syndrome, with or without severe fibrosis / compensated cirrhosis. Receives: Drug: Elbasvir/ Grazoprevir 50/100 mg fixed dose combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12 evaluation
The main outcome is SVR12, defined as HCV RNA < LLOQ (either TD[u] or TND)
Measured: 12 weeks after the end of all study therapy (treatment success).
Secondary outcomes (1)
Death/Lost
Death or lost to follow-up before W24 will be considered as treatment failure (in full analysis set).
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startOct 2017 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C Genotype 1BStudies of the same condition, open and under way.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute Of Cardiology & Internal Diseases, Kazakhstan
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC, Synergy Research Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222167
- Sponsor's protocol ID
- ICID.HCV.0117
- Status last verified
- Jul 2017
- First submitted
- 17 Jul 2017
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03222167
- Acronym / sponsor ID
- ICID.HCV.0117
- Keywords
- Elbasvir, Grazoprevir, SVR12, hepatitis C, metabolic syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Institute Of Cardiology & Internal Diseases, KazakhstanOther government
- Collaborators
- Merck Sharp & Dohme LLC, Synergy Research Group
- Study start
- Oct 2017 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 19 Jul 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.
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.
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
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 50/100 mg fixed dose combinationElbasvir/ Grazoprevir 50/100 mg fixed dose combination for 12 weeks treatment aimed to evaluate SVR12 in treatment naïve patients with chronic hepatitis C (genotype 1b) infection, associated with metabolic syndrome, with or without severe fibrosis / compensated cirrhosis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be 18-70 years of age on a day of signing of informed consent.
- Have ≤40 kg/m2.
- Have HCV RNA ≥ 10,000 IU/mL at the time of screening.
- Have documented chronic HCV GT1b (with no evidence of non-typeable or mixed genotype) infection (positive for anti-HCV antibody, HCV RNA, or HCV GT1b at least 6 months before screening).
- Have liver disease staging assessment by means of liver biopsy performed within 12 calendar months prior to Day 1 of this study or Fibroscan performed within 6 calendar months prior to Day 1 of this study (cut-off of 12.5 kPa has a positive predictive value of 90% and a sensitivity of 95% for ≥F3).
Key exclusion criteria (18 listed)
- Is below 18 years of age.
- Has not signed Informed Consent Document.
- Has HCV genotype other than genotype 1b.
- Has BMI > 40 kg/m2.
- Has history of clinically significant psychiatric disorder which in the opinion of the investigator, would interfere with the study procedures and compliance.
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 50/100 mg fixed dose combinationEnrolled patients will be treated by Elbasvir/ Grazoprevir 50/100 mg fixed dose combination during 12 week. Followed-up on week 24. SVR12 will be evaluated. | Drug | Elbasvir/ Grazoprevir |
Primary outcome
SVR12 evaluation
Time frame: 12 weeks after the end of all study therapy (treatment success).
The main outcome is SVR12, defined as HCV RNA < LLOQ (either TD[u] or TND)
1 secondary outcome
Death/Lost
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2017.
- Individual participant dataSharing planned: No
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.
National Research Institute of Cardiology and Internal Medicine
Almaty, Kazakhstan
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 50/100 mg fixed dose combination in people with Chronic Hepatitis C Genotype 1B and Metabolic Syndrome, run by Institute Of Cardiology & Internal Diseases, Kazakhstan at 1 site in Kazakhstan.
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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 7 Aug 2017. 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 Kazakhstan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 evaluation (time frame: 12 weeks after the end of all study therapy (treatment success).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2017.