Type 2 Diabetes Mellitus With Circulatory ComplciationPhase 2PH100_IIaNCT04141241
Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular
A Phase 2 study testing Ecklonia cava Phlorotannin in people with Type 2 Diabetes Mellitus With Circulatory Complciation, run by Bota Bio Co., Ltd..
Trial summary
This is a Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-Week, Therapeutic exploratory, Phase IIa Study which will patients with type 2 diabetes mellitus and recent cardiovascular complications. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus With Circulatory Complciation
- What is being tested?
- Ecklonia cava Phlorotannin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 4 Mar 2016to 4 May 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 19 years old
- Subjects who have been treated for cardiovascular complications (stent insertion due to angina pectoris, myocardial infarction, cerebral ischemia, peripheral vascular disease) within 4 weeks prior to baseline
- T2DM patients who diagnosed with type 2 diabetes prior to or above cardiovascular complications and have been taking oral hypoglycemic agents and/or receiving insulin treatment before the above complication occurred
- Subjects taking a stable dose of statins and are anticipated to have no change in dose during the duration of the study
- The following is confirmed through screening:
- AST/ALT ≤ 2.5 X ULN
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- Creatinine ≤ 1.5 X ULN
- Hemoglobin ≥ 10 g/dL
- 6.5% ≤ HbA1c ≤ 11%
- Women of child-bearing potential who have negative pregnancy testing results and have agreed to use appropriate measures of contraception* during the duration of the study (*appropriate contraception is defined as women of child-bearing potential, excluding women in whom more than 52 weeks have passed since their last period, using the following methods: surgical sterilization, intrauterine device, condoms, barrier contraceptives, absolute abstinence)
- Subjects who have signed the informed consent form (or whose legal representative has signed) and who are deemed to be able to follow the requirements of the study
Who cannot join
- T2DM patients, secondary DM patients, Gestational DM patients
- Subjects who have a history of secondary hypertension or have a disease history of suspicious secondary hypertension. This includes but is not restricted to: aortic coarctation, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
- Subjects taking anti-inflammatory agents including corticosteroids/NSAIDs (However, maximum 100mg of aspirin per day is allowed)
- Subjects with chronic liver/renal disease or malignancy
- Supplements containing kajime or kajime derivatives (e.g. Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Eckonia Cava, Seanol, Seanol-F, Seanol-EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, Marine D3, Botabio everyone, Botabio power, Botabio red, Botabio premium, Botabio Eplus) and related medications, or subjects who have a history of hypersensitivity to high iodine containing products (seaweed, shellfish, etc.)
- Pregnant, breast-feeding subjects or subjects who have plans for pregnancy
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- Subjects who have taken supplements containing kajime or kajime derivatives within 4 weeks of baseline (e.g., Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Eckonia Cava, Seanol, Seanol-F, Seanol- EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, Marine D3, Botabio everyone, Botabio power, Botabio red, Botabio premium, Botabio Eplus)
- Subjects who have participated in another clinical trial within 4 weeks of baseline and have taken other clinical trial medications
- Subjects who have received treatment for or who test positive for HBsAg, HCV antibody, or HIV at baseline
- Subjects who have an acute inflammatory disease other than cardiovascular complications within 4 weeks of baseline
- Subjects who have gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of drugs (e.g. Crohn's disease) and subjects who have a history of gastrointestinal surgery (with the exception of appendectomy and hernia repair), or subjects with active gastritis, gastrointestinal/rectal bleeding, active inflammatory bowel disease within the past 12 months
- Subjects with autoimmune disease (e.g. rheumatoid arthritis) or who require chronic anti-inflammatory treatment
- Subjects with a history of drug or alcohol abuse
- Subjects who are judged not to be appropriate for participation in the study or who have a medical condition that may have an influence on the study results
About this study
Official title: Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-week, Therapeutic Exploratory, Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular Complications
This is a Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-Week, Therapeutic exploratory, Phase IIa Study which will patients with type 2 diabetes mellitus and recent cardiovascular complications.
Read the detailed description
After a screening, 114 patients will be stratified randomized in a 1:1:1 ratio to the 3 arms (PH100 800mg/day, PH100 1600mg/day, Placebo) to evaluate the safety and efficacy of PH100.
Subjects will visit the centers on Week 4, 8 and 12 during the entire 12-week treatment period.
- Being tested
- Ecklonia cava Phlorotannin
- Keywords
- T2DM with Recent Cardiovascular Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecklonia cava PhlorotanninDrug
Also called PH100
Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose PH100: 800mg/day | Experimental | * PH100 (Ecklonia cava Phlorotannin) 200mg/tablet
* PH100 2 tablets (400mg) and Placebo 2 tablets BID during 12wks Receives: Drug: Ecklonia cava Phlorotannin |
| High Dose PH100: 1600mg/day | Experimental | - PH100 4 tablets (800mg) BID during 12wks Receives: Drug: Ecklonia cava Phlorotannin |
| Placebo | Placebo comparator | * Placebo 200mg/tablet
* Placebo 4 tablets BID during 12wks Receives: Drug: Ecklonia cava Phlorotannin |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-CRP (high-sensitivity C-reactive protein)
Change in hs-CRP level compared to baseline after 12 weeks of investigational product administration
Measured: Visit 2(Baseline Visit) vs Visit 5(week 12)
Secondary outcomes (26)
hs-CRP
Change in hs-CRP level compared to baseline after 4 weeks, 8 weeks of investigational product administration
Measured: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8)
hs-CRP: monthly rate of change
Change in hs-CRP level monthly
Measured: Between Visit 2(Baseline Visit) and Visit 3(week 4), Between Visit 3(week 4) and Visit 4(week 8), Between Visit 4(week 8) and Visit 5(week 12)
Interleukin-6 (IL-6)
Change in IL-6 [Inflammatory Marker]
Measured: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Tumor Necrosis Factor-α (TNF- α)
Change in TNF- α [Inflammatory Marker]
Measured: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Malondialdehyde (MDA)
Change in MDA [Biomarkers of oxidative stress]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Oxidized Low Density Lipoprotein (Oxidized LDL)
Change in Oxidized LDL [Biomarkers of oxidative stress]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Glutathione Peroxidase (GPX)
Change in GPX [Biomarkers of oxidative stress]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Superoxide Dismutase (SOD)
Change in SOD [Biomarkers of oxidative stress]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Total AntiOxidants (TAS)
Change in TAS [Biomarkers of oxidative stress]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
HbA1c
Change in HbA1c level compared to Visit1(screening) after 12 weeks of investigational product administration
Measured: Visit1(screening), Visit 5(week 12)
Adiponectin
Change in Adiponectin level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Free Fatty Acid
Change in Free Fatty Acid level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
High Density Lipoprotein-cholesterol (HDL-C)
Change in HDL-C level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration [Lipid Profile]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Low Density Lipoprotein-cholesterol (LDL-C)
Change in LDL-C level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration [Lipid Profile]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Triglyceride (TG)
Change in TG level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration [Lipid Profile]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Total Cholesterol (TC)
Change in TC level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration [Lipid Profile]
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Homocysteine
Change in Homocysteine level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Fibrinogen
Change in Fibrinogen level compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
MACE (Major Adverse Cardiovascular Events)
Incidence rate of MACE (Major Adverse Cardiovascular Events) during investigational product administration
Measured: Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Left Ventricular Ejection Fraction
Change in LVEFF compared to Visit 2(Baseline Visit) after 12 weeks of investigational product administration by Echocardiogram
Measured: Visit 2(Baseline Visit), Visit 5(week 12)
Blood Pressure (Systolic Blood Pressure, Diastolic Blood Pressure)
Change in SiSBP, SiDBP
Measured: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
BMI
Change in BMI
Measured: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Waist-hip ratio
Change in Waist-hip ratio
Measured: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
AE (Adverse Events)
[Safety and Tolerability] Incidence of AEs during investigational product administration
Measured: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Pulse
[Safety and Tolerability] Check the Vital Sign (pulse) every visit schedule
Measured: Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Body Temperature
[Safety and Tolerability] Check the Vital Sign (body temperature) every visit schedule
Measured: Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start4 Mar 2016
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus With Circulatory ComplciationStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bota Bio Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141241
- Sponsor's protocol ID
- BOTAB-DBCVC-PH100
- Acronym
- PH100_IIa
- Status last verified
- Nov 2019
- First submitted
- 21 Oct 2019
- Last updated
- 6 Nov 2019
- 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 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-week, Therapeutic Exploratory, Phase 2a Study to Evaluate the Safety and Efficacy of PH100 Tablet in T2DM Patients With Recent Cardiovascular Complications
- ClinicalTrials.gov ID
- NCT04141241
- Acronym / sponsor ID
- PH100_IIa / BOTAB-DBCVC-PH100
- Keywords
- T2DM with Recent Cardiovascular Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bota Bio Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 28 Oct 2019 (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, Randomized, Double-blinded, Placebo-controlled, Parallel-design, 12-Week, Therapeutic exploratory, Phase IIa Study which will patients with type 2 diabetes mellitus and recent cardiovascular complications.
Detailed description
After a screening, 114 patients will be stratified randomized in a 1:1:1 ratio to the 3 arms (PH100 800mg/day, PH100 1600mg/day, Placebo) to evaluate the safety and efficacy of PH100.
Subjects will visit the centers on Week 4, 8 and 12 during the entire 12-week treatment period.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose PH100: 800mg/day | Experimental | Drug: Ecklonia cava Phlorotannin* PH100 (Ecklonia cava Phlorotannin) 200mg/tablet * PH100 2 tablets (400mg) and Placebo 2 tablets BID during 12wks |
| High Dose PH100: 1600mg/day | Experimental | Drug: Ecklonia cava Phlorotannin- PH100 4 tablets (800mg) BID during 12wks |
| Placebo | Placebo comparator | Drug: Ecklonia cava Phlorotannin* Placebo 200mg/tablet * Placebo 4 tablets BID during 12wks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >= 19 years old
- Subjects who have been treated for cardiovascular complications (stent insertion due to angina pectoris, myocardial infarction, cerebral ischemia, peripheral vascular disease) within 4 weeks prior to baseline
- T2DM patients who diagnosed with type 2 diabetes prior to or above cardiovascular complications and have been taking oral hypoglycemic agents and/or receiving insulin treatment before the above complication occurred
- Subjects taking a stable dose of statins and are anticipated to have no change in dose during the duration of the study
- The following is confirmed through screening:
Key exclusion criteria (14 listed)
- T2DM patients, secondary DM patients, Gestational DM patients
- Subjects who have a history of secondary hypertension or have a disease history of suspicious secondary hypertension. This includes but is not restricted to: aortic coarctation, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.
- Subjects taking anti-inflammatory agents including corticosteroids/NSAIDs (However, maximum 100mg of aspirin per day is allowed)
- Subjects with chronic liver/renal disease or malignancy
- Supplements containing kajime or kajime derivatives (e.g. Seapolynol, Fibroboost, Fibronol, Seanol Longevity Plus, Circulate, Alginol, PC Eckonia Cava, Seanol, Seanol-F, Seanol-EX, Seanol-TX, Venusen, Memories with Seanol-P, Astaxanthol, Brilliant Vision with Seanol-P, Gly-Control, Gyne-Andro-Plex, Lipid Balance, Seanol with Broccoraphanin, Marine D3, Botabio everyone, Botabio power, Botabio red, Botabio premium, Botabio Eplus) and related medications, or subjects who have a history of hypersensitivity to high iodine containing products (seaweed, shellfish, etc.)
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 |
|---|---|---|
| Ecklonia cava PhlorotanninAlso: PH100Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion. | Drug | High Dose PH100: 1600mg/day, Low Dose PH100: 800mg/day, Placebo |
Primary outcome
hs-CRP (high-sensitivity C-reactive protein)
Time frame: Visit 2(Baseline Visit) vs Visit 5(week 12)
Change in hs-CRP level compared to baseline after 12 weeks of investigational product administration
26 secondary outcomes
hs-CRP
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8)
hs-CRP: monthly rate of change
Time frame: Between Visit 2(Baseline Visit) and Visit 3(week 4), Between Visit 3(week 4) and Visit 4(week 8), Between Visit 4(week 8) and Visit 5(week 12)
Interleukin-6 (IL-6)
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Tumor Necrosis Factor-α (TNF- α)
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Malondialdehyde (MDA)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Oxidized Low Density Lipoprotein (Oxidized LDL)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Glutathione Peroxidase (GPX)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Superoxide Dismutase (SOD)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Total AntiOxidants (TAS)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
HbA1c
Time frame: Visit1(screening), Visit 5(week 12)
Adiponectin
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Free Fatty Acid
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
High Density Lipoprotein-cholesterol (HDL-C)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Low Density Lipoprotein-cholesterol (LDL-C)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Triglyceride (TG)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Total Cholesterol (TC)
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Homocysteine
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Fibrinogen
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
MACE (Major Adverse Cardiovascular Events)
Time frame: Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Left Ventricular Ejection Fraction
Time frame: Visit 2(Baseline Visit), Visit 5(week 12)
Blood Pressure (Systolic Blood Pressure, Diastolic Blood Pressure)
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
BMI
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Waist-hip ratio
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
AE (Adverse Events)
Time frame: Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Pulse
Time frame: Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
Body Temperature
Time frame: Visit 1(Screening), Visit 2(Baseline Visit), Visit 3(week 4), Visit 4(week 8), Visit 5(week 12)
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 6 Nov 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ecklonia cava Phlorotannin in people with Type 2 Diabetes Mellitus With Circulatory Complciation, run by Bota Bio Co., Ltd..
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 11 inclusion and 14 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 6 Nov 2019. 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. Some participants in this study may receive a placebo. 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?
hs-CRP (high-sensitivity C-reactive protein) (time frame: Visit 2(Baseline Visit) vs Visit 5(week 12)). 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 6 Nov 2019.