Hepatitis C, ChronicPhase 3NCT01370642

Vaniprevir Administered With Pegylated-interferon and Ribavirin in Japanese Treatment-Naïve Chronic Hepatitis C Participants (MK-7009-043)

A Phase 3 study testing vaniprevir, Peg-IFN and ribavirin in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: vaniprevir, Peg-IFN and ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 294 participants
Where: No sites listed yet
Study dates: 27 Jun 2011to 17 Mar 2014
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 20 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Japanese participant diagnosed with compensated CHC GT 1
Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
IFN treatment naive
No evidence of cirrhosis

Who cannot join

Co-infection with human immunodeficiency virus (HIV)
Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant.

About this study

Official title: A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection

The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (peg-IFN) and ribavirin (RBV) versus treatment with peg-IFN and RBV alone in Japanese treatment-naïve participants with chronic hepatitis C (CHC) genotype (GT)1. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir arms is superior to the percentage of participants achieving SVR24 in the control arm.

Conditions: Hepatitis C, Chronic
Being tested: vaniprevir, Placebo to vaniprevir, Peg-IFN, ribavirin
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.

vaniprevirDrug
Also called MK-7009
Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
Placebo to vaniprevirDrug
Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks
Peg-IFNBiological
Also called PegIntron
Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks
ribavirinDrug
Also called REBETOL®
Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks

Study groups in NCT01370642
Study group	Role	What they receive
Vaniprevir 12 Week Arm	Experimental	Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV. Receives: Drug: vaniprevir; Drug: Placebo to vaniprevir; Biological: Peg-IFN; Drug: ribavirin
Vaniprevir 24 Week Arm	Experimental	Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV. Receives: Drug: vaniprevir; Biological: Peg-IFN; Drug: ribavirin
Control Arm	Active comparator	Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV. Receives: Drug: Placebo to vaniprevir; Biological: Peg-IFN; Drug: ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.
Measured: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted "Tier 1" safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).
Measured: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
Percentage of Participants Who Discontinued Study Drug Due to an AE
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.
Measured: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)

Secondary outcomes (5)

Percentage of Participants Achieving SVR12
SVR12 was defined as having an undetectable HCV RNA level 12 weeks after completion of all study therapy.
Measured: 12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)
Percentage of Participants Achieving Rapid Virologic Response (RVR)
RVR was defined as having an undetectable HCV RNA level at Week 4.
Measured: At Week 4
Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
cEVR was defined as having an undetectable HCV RNA level at Week 12.
Measured: At Week 12
Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
Participants were assessed for undetectable HCV RNA levels at the end of all study therapy.
Measured: At Week 24 or 48
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)
HCV RNA levels were assessed at baseline (BL) and during treatment weeks 2, 4, 8, 12, and 24 using the Roche TaqMan HCV assay, and transformed to Log 10 values. HCV RNA values below the limit of reliable quantification (LoQ) or the limit of detection (LoD) at any time point were handled as follows (imputations done for computational purposes): values below the LoQ but above the LoD were imputed with the LoQ minus 0.1; values below the LoD were imputed with the value of 0 Log IU/mL. HCV RNA levels below the LoD were considered "undetectable".
Measured: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jun 201117 Mar 2014

First posted10 Jun 2011 (estimated)
Study start27 Jun 2011
Primary completion31 Jul 2013
Study completion17 Mar 2014

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 (2)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 Merck Sharp & Dohme LLCThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 294 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01370642
Sponsor's protocol ID: 7009-043
Status last verified: Sep 2018
First submitted: 8 Jun 2011
Last updated: 18 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Hayashi N, Nakamuta M, Takehara T, Kumada H, Takase A, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study. J Gastroenterol. 2016 Apr;51(4):390-403. doi: 10.1007/s00535-015-1120-x. Epub 2015 Sep 25.
PubMed 26403160
Ludmerer SW, Hirano T, Black S, Howe AY, Chang W, Takase A, Nakamura K, Tanaka Y, Kumada H, Hayashi N, Nickle D. HCV evolutionary genetics of SVR versus virologic failure assessed from the vaniprevir phase III registration trials. Antiviral Res. 2016 Jun;130:118-29. doi: 10.1016/j.antiviral.2016.03.004. Epub 2016 Mar 3.
PubMed 26947564

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of MK-7009 When Administered Concomitantly With Peginterferon Alfa-2b and Ribavirin in Japanese Treatment-Naïve Patients With Chronic Hepatitis C Infection
ClinicalTrials.gov ID: NCT01370642
Acronym / sponsor ID: 7009-043
Conditions: Hepatitis C, Chronic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 294 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 27 Jun 2011 (actual)
Primary completion: 31 Jul 2013 (actual)
Study completion: 17 Mar 2014 (actual)
First posted: 10 Jun 2011 (estimated)
Results: Posted 6 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Vaniprevir 12 Week Arm	Experimental	Drug: vaniprevir, Drug: Placebo to vaniprevir, Biological: Peg-IFN, Drug: ribavirinParticipants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
Vaniprevir 24 Week Arm	Experimental	Drug: vaniprevir, Biological: Peg-IFN, Drug: ribavirinParticipants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
Control Arm	Active comparator	Drug: Placebo to vaniprevir, Biological: Peg-IFN, Drug: ribavirinParticipants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Japanese participant diagnosed with compensated CHC GT 1
Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
IFN treatment naive
No evidence of cirrhosis

Key exclusion criteria (4 listed)

Co-infection with human immunodeficiency virus (HIV)
Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant.

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
vaniprevirAlso: MK-7009Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks	Drug	Vaniprevir 12 Week Arm, Vaniprevir 24 Week Arm
Placebo to vaniprevirPlacebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks	Drug	Control Arm, Vaniprevir 12 Week Arm
Peg-IFNAlso: PegIntronPeg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks	Biological	Control Arm, Vaniprevir 12 Week Arm, Vaniprevir 24 Week Arm
ribavirinAlso: REBETOL®Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks	Drug	Control Arm, Vaniprevir 12 Week Arm, Vaniprevir 24 Week Arm

Primary outcome

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)
Time frame: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)
SVR24 was defined as having an undetectable HCV RNA level 24 weeks after completion of all study therapy.
Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study
Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience. For this study, safety parameters or AEs of special interest that were identified a priori constituted "Tier 1" safety endpoints that were subject to inferential testing for statistical significance. Tier 1 AEs on this study included serious rash, anemia (anemia plus haemoglobin decreased), neutropenia (neutropenia plus neutrophil count decreased), bilirubin increased and gastrointestinal adverse (GI) experiences (vomiting, nausea, and diarrhea).
Percentage of Participants Who Discontinued Study Drug Due to an AE
Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks)
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also an adverse experience.

5 secondary outcomes

Percentage of Participants Achieving SVR12
Time frame: 12 weeks after 24 or 48 weeks of study therapy (up to 60 weeks)
Percentage of Participants Achieving Rapid Virologic Response (RVR)
Time frame: At Week 4
Percentage of Participants Achieving Complete Early Virologic Response (cEVR)
Time frame: At Week 12
Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT)
Time frame: At Week 24 or 48
Least Squares (LS) Mean Change From Baseline in HCV RNA (Log 10)
Time frame: Baseline, Week 2, Week 4, Week 8, Week 12, Week 24

Results and safety

Results posted to the registry on 6 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaniprevir 12 Week Arm	98	90
Vaniprevir 24 Week Arm	98	92
Control Arm	98	69

Primary outcome: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24)

Time frame: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks). Number. Unit: percentage of participants

Measure	Vaniprevir 12 Week Arm n = 98	Vaniprevir 24 Week Arm n = 97	Control Arm n = 98
Value	83.7	84.5	55.1

Vaniprevir 12 Week Arm vs Control Arm: Adjusted Difference in Percentages: 29.0 (95% CI 17.2 to 40.5), p <0.001, Miettinen and Nurminen method
Vaniprevir 24 Week Arm vs Control Arm: Adjusted Difference in Percentages: 28.6 (95% CI 17.4 to 40.0), p <0.001, Miettinen and Nurminen method

Population analysed: Full Analysis Set (FAS) population; all randomized participants who received at least one dose of study treatment. One treated participant was excluded from the FAS due to a protocol violation.

Primary outcome: Percentage of Participants With One or More Tier 1 Adverse Events (AEs) During the Study

Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks). Number. Unit: percentage of participants

Measure	Vaniprevir 12 Week Arm n = 98	Vaniprevir 24 Week Arm n = 97	Control Arm n = 98
With ≥1 Tier 1 AEs	89.8	83.5	85.7
anaemia	60.2	51.5	64.3
bilirubin increased	7.1	12.4	701
GI AEs	62.2	52.6	46.9
neutropenia	59.2	51.5	51.0

Vaniprevir 12 Week Arm vs Control Arm: Difference in percentages: 4.1 (95% CI -5.4 to 13.7), p = 0.385, Miettinen and Nurminen method
Vaniprevir 24 Week Arm vs Control Arm: Difference in percentages: -2.2 (95% CI -12.6 to 8.1), p = 0.670, Miettinen and Nurminen method
Vaniprevir 12 Week Arm vs Control Arm: Difference in percentages: -4.1 (95% CI -17.5 to 9.5), p = 0.557, Miettinen and Nurminen method

Population analysed: All Participants Treated (APaT) Population; all participants receiving at least one dose of study treatment. One treated participant was excluded from the APaT due to a protocol violation.

Primary outcome: Percentage of Participants Who Discontinued Study Drug Due to an AE

Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks). Number. Unit: percentage of participants

Measure	Vaniprevir 12 Week Arm n = 98	Vaniprevir 24 Week Arm n = 97	Control Arm n = 98
Value	7.1	3.1	11.2

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 (post-dose) through completion of Week 24 Follow-up (up to 72 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaniprevir 12 Week Arm	5 of 98 (5.1%)	98 of 98 (100%)	Not reported
Vaniprevir 24 Week Arm	6 of 97 (6.2%)	97 of 97 (100%)	Not reported
Control Arm	9 of 98 (9.2%)	98 of 98 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26403160Hayashi N, Nakamuta M, Takehara T, Kumada H, Takase A, Howe AY, Ludmerer SW, Mobashery N. Vaniprevir plus peginterferon alfa-2b and ribavirin in treatment-naive Japanese patients with hepatitis C virus genotype 1 infection: a randomized phase III study. J Gastroenterol. 2016 Apr;51(4):390-403. doi: 10.1007/s00535-015-1120-x. Epub 2015 Sep 25.
Derived from this study: PubMed 26947564Ludmerer SW, Hirano T, Black S, Howe AY, Chang W, Takase A, Nakamura K, Tanaka Y, Kumada H, Hayashi N, Nickle D. HCV evolutionary genetics of SVR versus virologic failure assessed from the vaniprevir phase III registration trials. Antiviral Res. 2016 Jun;130:118-29. doi: 10.1016/j.antiviral.2016.03.004. Epub 2016 Mar 3.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Hepatitis C, Chronic

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing vaniprevir, Peg-IFN and ribavirin in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.

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 4 inclusion and 4 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 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

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 6 Oct 2014). 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?

Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24) (time frame: 24 weeks after 24 or 48 weeks of study therapy (up to 72 weeks)). The study lists 3 primary outcomes in all. 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 NCT01370642, which also lists 2 linked publications.

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 18 Oct 2018.