Hepatitis C, ChronicPhase 2NCT01331850
A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
A Phase 2 study testing Copegus, Pegasys and RO5024048 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 67 sites in 13 countries.
Trial summary
This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Copegus, Pegasys and RO5024048
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 67 sitesin 13 countries
- Study dates
- May 2011to Jan 2013
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, age 18 years and older
- Presence of hepatitis C infection, genotype 1a or 1b
- Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
- Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start
Who cannot join
- Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
- Patients with cirrhosis
- Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
- Co-infection with hepatitis B or human immunodeficiency virus (HIV)
- History or evidence of chronic liver disease other than hepatitis C
Trial locations and contacts
67 sites in 13 countries.
67 sites in 13 countries
United States19 sites
Study site
Aurora, Colorado, 80045
Study site
Chapel Hill, North Carolina, 27599-7584
Study site
Chicago, Illinois, 60637
Study site
Decatur, Georgia, 30033
Study site
Detroit, Michigan, 48202-2689
Study site
Houston, Texas, 77030
Study site
La Jolla, California, 92037-1030
Study site
Long Beach, California, 90822
Study site
Manhasset, New York, 11030
Study site
Medford, Oregon, 97504
Study site
Nashville, Tennessee, 37211
Study site
New Orleans, Louisiana, 70112
Study site
New York, New York, 10021
Study site
Orlando, Florida, 32804
Study site
Providence, Rhode Island, 02905
Study site
Sacramento, California, 95817
Study site
San Antonio, Texas, 78215
Study site
San Antonio, Texas, 78234
Study site
San Diego, California, 92103
Canada8 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
Edmonton, Alberta, T6G 2B7
Study site
London, Ontario, N6A 5A5
Study site
Ottawa, Ontario, K1H 8L6
Study site
Toronto, Ontario, M5G 1L7
Study site
Vancouver, British Columbia, V5Z 1H2
Study site
Vancouver, British Columbia, V5Z 1M9
Study site
Vancouver, British Columbia, V6Z 2K5
Australia6 sites
Study site
Adelaide, South Australia, 5000
Study site
Darlinghurst, New South Wales, 2010
Study site
Kingswood, New South Wales, 2747
Study site
Melbourne, Victoria, 3004
Study site
Melbourne, Victoria, 3186
Study site
Westmead, New South Wales, 2145
France5 sites
Study site
La Tronche, 38700
Study site
Paris, 75651
Study site
Paris, 75679
Study site
Pessac, 33604
Study site
Vandœuvre-lès-Nancy, 54511
Poland5 sites
Study site
Bydgoszcz, 85-030
Study site
Czeladź, 41-250
Study site
Kielce, 25-317
Study site
Lodz, 91-347
Study site
Warsaw, 01-201
Spain5 sites
Study site
Badalona, Barcelona, 08915
Study site
Barcelona, Barcelona, 08003
Study site
Madrid, Madrid, 28034
Study site
Madrid, Madrid, 28222
Study site
Seville, Sevilla, 41014
United Kingdom5 sites
Study site
Birmingham, B15 2TH
Study site
Dundee, DD1 9SY
Study site
London, E1 1BB
Study site
London, W2 1PG
Study site
Manchester, M8 5RB
Germany4 sites
Study site
Berlin, 13353
Study site
Essen, 45122
Study site
Kiel, 24105
Study site
Tübingen, 72076
Italy4 sites
Study site
Milan, Lombardy, 20162
Study site
Naples, Campania, 80135
Study site
Pavia, Lombardy, 27100
Study site
Pisa, Tuscany, 56124
Brazil2 sites
Study site
Porto Alegre, Rio Grande do Sul, 90035-003
Study site
Ribeirão Preto, São Paulo, 14049-900
About this study
Official title: A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy
This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Copegus, Pegasys, RO5024048, danoprevir, ritonavir
- 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.
CopegusDrug
1000 mg or 1200 mg daily oral doses for 24 weeks
CopegusDrug
1000 mg or 1200 mg daily oral doses for 48 weeks
PegasysDrug
180 microgram subcutaneously once weekly for 24 weeks
PegasysDrug
180 microgram subcutaneously once weekly for 48 weeks
RO5024048Drug
1000 mg oral doses twice a day for 24 weeks
danoprevirDrug
100 mg oral doses twice a day for 24 weeks
ritonavirDrug
100 mg oral doses twice a day for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Previous null responders (Cohort B): Group 4 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. Receives: Drug: Copegus; Drug: RO5024048; Drug: danoprevir; Drug: ritonavir |
| Previous null responders (Cohort B): Group 5 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048; Drug: danoprevir; Drug: ritonavir |
| Previous null responders (Cohort B): Group 6 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment. Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048; Drug: danoprevir; Drug: ritonavir |
| Previous partial responders (Cohort A): Group 1 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. Receives: Drug: Copegus; Drug: RO5024048; Drug: danoprevir; Drug: ritonavir |
| Previous partial responders (Cohort A): Group 2 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. Receives: Drug: Copegus; Drug: Pegasys; Drug: danoprevir; Drug: ritonavir |
| Previous partial responders (Cohort A): Group 3 | Experimental | Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. Receives: Drug: Copegus; Drug: Pegasys; Drug: RO5024048; Drug: danoprevir; Drug: ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Measured: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment
Measured: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Measured: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment
Measured: 48 weeks
Secondary outcomes (7)
Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus
Measured: 48 weeks
Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus
Measured: 48 weeks
Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus
Measured: 72 weeks
Virological response over time
Measured: 48 weeks
Change in danoprevir plasma concentration
Measured: 24 weeks
Change in RO5024048 plasma concentration
Measured: 24 weeks
Hepatitis C virus drug resistance profile
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 posted8 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331850
- Sponsor's protocol ID
- WV21913
- Other IDs
- 2010-019585-90
- Status last verified
- Nov 2016
- First submitted
- 28 Mar 2011
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy
- ClinicalTrials.gov ID
- NCT01331850
- Acronym / sponsor ID
- WV21913
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Apr 2011 (estimated)
- 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 randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Previous null responders (Cohort B): Group 4 | Experimental | Drug: Copegus, Drug: RO5024048, Drug: danoprevir, Drug: ritonavirPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous null responders (Cohort B): Group 5 | Experimental | Drug: Copegus, Drug: Pegasys, Drug: RO5024048, Drug: danoprevir, Drug: ritonavirPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous null responders (Cohort B): Group 6 | Experimental | Drug: Copegus, Drug: Pegasys, Drug: RO5024048, Drug: danoprevir, Drug: ritonavirPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment. |
| Previous partial responders (Cohort A): Group 1 | Experimental | Drug: Copegus, Drug: RO5024048, Drug: danoprevir, Drug: ritonavirPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous partial responders (Cohort A): Group 2 | Experimental | Drug: Copegus, Drug: Pegasys, Drug: danoprevir, Drug: ritonavirPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
| Previous partial responders (Cohort A): Group 3 | Experimental | Drug: Copegus, Drug: Pegasys, Drug: RO5024048, Drug: danoprevir, Drug: ritonavirPatients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients, age 18 years and older
- Presence of hepatitis C infection, genotype 1a or 1b
- Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
- Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start
Key exclusion criteria (5 listed)
- Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
- Patients with cirrhosis
- Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
- Co-infection with hepatitis B or human immunodeficiency virus (HIV)
- History or evidence of chronic liver disease other than hepatitis C
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 |
|---|---|---|
| Copegus1000 mg or 1200 mg daily oral doses for 24 weeks | Drug | Previous null responders (Cohort B): Group 4, Previous null responders (Cohort B): Group 5, Previous partial responders (Cohort A): Group 1, Previous partial responders (Cohort A): Group 2, Previous partial responders (Cohort A): Group 3 |
| Copegus1000 mg or 1200 mg daily oral doses for 48 weeks | Drug | Previous null responders (Cohort B): Group 6 |
| Pegasys180 microgram subcutaneously once weekly for 24 weeks | Drug | Previous null responders (Cohort B): Group 5, Previous partial responders (Cohort A): Group 2, Previous partial responders (Cohort A): Group 3 |
| Pegasys180 microgram subcutaneously once weekly for 48 weeks | Drug | Previous null responders (Cohort B): Group 6 |
| RO50240481000 mg oral doses twice a day for 24 weeks | Drug | Previous null responders (Cohort B): Group 4, Previous null responders (Cohort B): Group 5, Previous null responders (Cohort B): Group 6, Previous partial responders (Cohort A): Group 1, Previous partial responders (Cohort A): Group 3 |
| danoprevir100 mg oral doses twice a day for 24 weeks | Drug | Previous null responders (Cohort B): Group 4, Previous null responders (Cohort B): Group 5, Previous null responders (Cohort B): Group 6, Previous partial responders (Cohort A): Group 1, Previous partial responders (Cohort A): Group 2, Previous partial responders (Cohort A): Group 3 |
| ritonavir100 mg oral doses twice a day for 24 weeks | Drug | Previous null responders (Cohort B): Group 4, Previous null responders (Cohort B): Group 5, Previous null responders (Cohort B): Group 6, Previous partial responders (Cohort A): Group 1, Previous partial responders (Cohort A): Group 2, Previous partial responders (Cohort A): Group 3 |
Primary outcome
Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Time frame: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment
Time frame: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Time frame: 24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment
Time frame: 48 weeks
7 secondary outcomes
Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus
Time frame: 48 weeks
Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus
Time frame: 48 weeks
Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus
Time frame: 72 weeks
Virological response over time
Time frame: 48 weeks
Change in danoprevir plasma concentration
Time frame: 24 weeks
Change in RO5024048 plasma concentration
Time frame: 24 weeks
Hepatitis C virus drug resistance profile
Time frame: 24 weeks
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 2 Nov 2016.
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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.
Clinical Trials study director
Hoffmann-La Roche
67 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Copegus, Pegasys and RO5024048 in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 67 sites in 13 countries.
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 5 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada, Australia, France, Poland and 8 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 2 Nov 2016.