Influenza APhase 3NCT02287467
Evaluating the Safety and Efficacy of Anti-Influenza Intravenous Hyperimmune Immunoglobulin (IVIG) in Adults Hospitalized With Influenza
A Phase 3 study testing Intravenous hyperimmune immunoglobulin (IVIG) in people with Influenza A and Influenza B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 4 countries.
Trial summary
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza A, Influenza B
- What is being tested?
- Intravenous hyperimmune immunoglobulin (IVIG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 329 participants
- Where
- 21 sitesin 4 countries
- Study dates
- Jan 2015to 7 Jun 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Locally determined positive influenza test (by polymerase chain reaction [PCR] or other nucleic acid test, or by rapid antigen [Ag]) from a specimen obtained within 2 days prior to randomization
- Onset of illness no more than 7 days before randomization, defined as when the participant first experienced at least one respiratory symptom or fever
- Hospitalized (or in observation unit) for influenza, with anticipated hospitalization for more than 24 hours. Criteria for hospitalization will be up to the individual treating clinician.
- For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least one form of hormonal or barrier contraception through Day 28 of the study
- Willingness to have blood and respiratory samples obtained and stored
- NEW score greater than or equal to 2 at screening (see the protocol for more information on this criterion)
Who cannot join
- Women who are pregnant or breast-feeding
- Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin
- Prior treatment with any investigational drug therapy within 30 days prior to screening
- History of allergic reaction to blood or plasma products (as judged by the site investigator)
- Known immunoglobulin A (IgA) deficiency
- A pre-existing condition or use of a medication that, in the opinion of the site investigator, may place the participant at a substantially increased risk of thrombosis (e.g., cryoglobulinemia, severe refractory hypertriglyceridemia, or clinically significant monoclonal gammopathy)
Show all 11Show fewer
- Presence of any pre-existing illness that, in the opinion of the site investigator, would place the participant at an unreasonably increased risk through participation in this study
- Participants who, in the judgment of the site investigator, will be unlikely to comply with the requirements of this protocol
- Medical conditions for which receipt of a 500 mL volume of intravenous fluid may be dangerous to the participant (e.g., decompensated congestive heart failure)
- Receiving extracorporeal membrane oxygenation (ECMO)
- Suspicion that infection is due to an influenza strain or subtype other than A(H1N1)pdm09, H3N2, or influenza B (e.g., H5N1, H7N9)
Trial locations and contacts
21 sites in 4 countries.
21 sites in 4 countries
United States17 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Cooper University Hospital
Camden, New Jersey, 08103
University of Illinois
Chicago, Illinois, 60612
Case Western Reserve University
Cleveland, Ohio, 44106
OHIO State University (OSU) Wexner Medical Center
Columbus, Ohio, 43210
UT Southwestern Medical Center
Dallas, Texas, 75235
Miami Valley Hospital
Dayton, Ohio, 45409
Denver Public Health
Denver, Colorado, 80204
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
West Virginia University
Morgantown, West Virginia, 26506
Cornell CRS
New York, New York, 10010
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
UCSD Antiviral Research Center (A VRC)
San Diego, California, 92103
Montefiore Medical Center
The Bronx, New York, 10467
United Kingdom2 sites
St James's University Hospital
Leeds
Churchill Hospital
Oxford
About this study
Official title: Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.
Read the detailed description
Influenza is responsible for thousands of hospitalizations and deaths each year in the United States and worldwide. One possible new treatment for the flu involves the use of IVIG, a blood product containing antibodies from people who have recovered from the flu or who have had a flu shot. The purpose of this study is to evaluate whether IVIG can reduce the severity and duration of flu in people who are hospitalized with the flu.
The study will enroll participants 18 years and older who are hospitalized with the flu. The study will enroll participants over one or more flu seasons. Regardless of the date of enrollment, each participant will be in the study for about 28 days.
At study entry (Day 0), participants will be randomly assigned to one of two groups (Arms A and B). Participants in both groups will receive standard of care (SOC) treatment for the flu, but those in Arm A will also receive one dose of IVIG and those in Arm B will receive a placebo for IVIG. Both IVIG and placebo will be given intravenously over at least 2 hours.
On Day 0, before receiving IVIG or placebo, participants will undergo a symptoms assessment, blood collection, and a nasopharyngeal (NP) swab to collect a sample of secretions from the nose and throat.
Additional study visits will occur on Days 1, 2, 3, 7, 14, and 28. Depending on the visit, participants may take part in the same study procedures that took place on Day 0. On Days 2, 14, and 28, visits for participants who are no longer hospitalized may be conducted over the phone.
- Conditions
- Influenza A, Influenza B
- Being tested
- Intravenous hyperimmune immunoglobulin (IVIG), Placebo for IVIG
- Keywords
- Antiviral, IVIG, Hemagglutination inhibition (HAI), Antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous hyperimmune immunoglobulin (IVIG)Biological
Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
Placebo for IVIGBiological
Administered IV as 500 mL of normal saline
| Study group | Role | What they receive |
|---|---|---|
| Arm A: hIVIG | Experimental | Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu. Receives: Biological: Intravenous hyperimmune immunoglobulin (IVIG) |
| Arm B: Placebo | Placebo comparator | Participants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu. Receives: Biological: Placebo for IVIG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients in Each of 6 Clinical Status Categories on Day 7
This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).
Measured: Assessed on Day 7
Secondary outcomes (18)
Number of Patients in Each of 5 Clinical Status Categories on Day 3
5-category ordinal outcome assessed on day 3; clinical status ranges from death (worst) to discharged from the hospital (best).
Measured: Assessed on Day 3
Number of Patients in Each of 6 Clinical Status Categories on Day 3
6-category ordinal outcome evaluated on Day 3; clinical status ranges from death (worst) to discharged from hospital with resumption of normal activities (best).
Measured: Measured on Day 3
Number of Patients With a Favorable Outcome on Day 7
Sliding dichotomy defined as non-ICU hospitalization or discharge if enrolled from ICU, and discharge if enrolled from the general ward.
Measured: Assessed on Day 7
Hospital Discharge
Number of participants alive and discharged from the hospital
Measured: Measured through Day 7
Mortality
Number of participants dying through day 28.
Measured: Measured through day 28
Number of Patients Alive and Out of Hospital
Number and percent alive and out of hospital on day 28
Measured: Measured through Day 28
Change in Viral Load
Change in nasopharyngeal viral load from baseline to day 3
Measured: Day 3
Death or Re-hospitalization
Number and percent of participants who died or were re-hospitalized after initial discharge
Measured: Day 28
Percent of Participants Developing Complications
Number and percent of participants developing respiratory distress syndrome, acute renal failure, sepsis, pneumonia, enteritis, or bronchitis
Measured: Measured through Day 28
Number of Patients in Each of 6 Clinical Status Categories on Day 14
6-category ordinal outcome measured on day 14
Measured: Measured on day 14
Number of Patients Alive and Out of Hospital on Day 14
Number and percentage of participants alive and out of the hospital on Day 14
Measured: day 14
Resumption of Normal Activities by Day 14
Participants reporting resumption of normal daily activities by Day 14
Measured: day 14
Number of Patients in Each of 6 Clinical Status Categories on Day 28
6-category ordinal outcome corresponding to clinical status on day 28
Measured: day 28
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Primary 6-category ordinal outcome for participants infected with Influenza A
Measured: Day 7
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Primary 6-category ordinal outcome for subgroup of participants infected with influenza B
Measured: Day 7
pH1N1 Titers at Day 7
pH1N1 hemagglutination inhibition assay (HAI) titers among participants infected with pH1N1 using A/Cal/2009 as reference virus
Measured: Day 7
H3N2 Titers at Day 7
H3N2 HAI titers among participants infected with H3N2 using A/HongKong/2014 as reference virus
Measured: Day 7
Influenza B Titers at Day 7
Flu B HAI titers among participants infected with influenza B using B/Phuket/2013 as reference virus
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startJan 2015
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
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 Influenza AStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 329 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Minnesota, International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Responsible party
- Sponsor
- Investigators
- Richard T. Davey, Jr., MD, Study chair, National Institute of Allergy and Infectious Diseases (NIAID)Eduardo Fernández-Cruz, MD, PhD, Study chair, Hospital General Universitario Gregorio MarañonNorman P. Markowitz, MD, Study chair, The Henry Ford HospitalSarah L. Pett, MD, MBBS, DTM, MRCP (UK), Study chair, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02287467
- Sponsor's protocol ID
- INSIGHT 006: FLU-IVIG
- Status last verified
- Nov 2019
- First submitted
- 6 Nov 2014
- Last updated
- 14 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Vanderven HA, Wentworth DN, Han WM, Peck H, Barr IG, Davey RT Jr, Beigel JH, Dwyer DE, Jain MK, Angus B, Brandt CT, Mykietiuk A, Law MG, Neaton JD, Kent SJ; INSIGHT FLU-IVIG Study Group. Understanding the treatment benefit of hyperimmune anti-influenza intravenous immunoglobulin (Flu-IVIG) for severe human influenza. JCI Insight. 2023 Jul 24;8(14):e167464. doi: 10.1172/jci.insight.167464.
PubMed 37289541Davey RT Jr, Fernandez-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2019 Nov;7(11):951-963. doi: 10.1016/S2213-2600(19)30253-X. Epub 2019 Sep 30.
PubMed 31582358
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Influenza Hyperimmune Intravenous Immunoglobulin Clinical Outcome Study (INSIGHT 006: FLU-IVIG)
- ClinicalTrials.gov ID
- NCT02287467
- Acronym / sponsor ID
- INSIGHT 006: FLU-IVIG
- Conditions
- Influenza A, Influenza B
- Keywords
- Antiviral, IVIG, Hemagglutination inhibition (HAI), Antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 329 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- University of Minnesota, International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
- Study start
- Jan 2015
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 10 Nov 2014 (estimated)
- Results
- Posted 14 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Influenza (the flu) is a common illness that usually occurs in autumn and winter. The flu is usually mild, but can cause serious illness or death. The purpose of this study is to test the safety and effectiveness of an antibody against the flu (called intravenous hyperimmune immunoglobulin or IVIG) in people who are hospitalized for severe flu.
Detailed description
Influenza is responsible for thousands of hospitalizations and deaths each year in the United States and worldwide. One possible new treatment for the flu involves the use of IVIG, a blood product containing antibodies from people who have recovered from the flu or who have had a flu shot. The purpose of this study is to evaluate whether IVIG can reduce the severity and duration of flu in people who are hospitalized with the flu.
The study will enroll participants 18 years and older who are hospitalized with the flu. The study will enroll participants over one or more flu seasons. Regardless of the date of enrollment, each participant will be in the study for about 28 days.
At study entry (Day 0), participants will be randomly assigned to one of two groups (Arms A and B). Participants in both groups will receive standard of care (SOC) treatment for the flu, but those in Arm A will also receive one dose of IVIG and those in Arm B will receive a placebo for IVIG. Both IVIG and placebo will be given intravenously over at least 2 hours.
On Day 0, before receiving IVIG or placebo, participants will undergo a symptoms assessment, blood collection, and a nasopharyngeal (NP) swab to collect a sample of secretions from the nose and throat.
Additional study visits will occur on Days 1, 2, 3, 7, 14, and 28. Depending on the visit, participants may take part in the same study procedures that took place on Day 0. On Days 2, 14, and 28, visits for participants who are no longer hospitalized may be conducted over the phone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: hIVIG | Experimental | Biological: Intravenous hyperimmune immunoglobulin (IVIG)Participants will receive a single infusion of intravenous hyperimmune immunoglobulin (hIVIG), administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu. |
| Arm B: Placebo | Placebo comparator | Biological: Placebo for IVIGParticipants will receive a single infusion of placebo for hIVIG, administered over approximately 2 hours on Day 0. Participants will also receive SOC treatment for the flu. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent
- Locally determined positive influenza test (by polymerase chain reaction [PCR] or other nucleic acid test, or by rapid antigen [Ag]) from a specimen obtained within 2 days prior to randomization
- Onset of illness no more than 7 days before randomization, defined as when the participant first experienced at least one respiratory symptom or fever
- Hospitalized (or in observation unit) for influenza, with anticipated hospitalization for more than 24 hours. Criteria for hospitalization will be up to the individual treating clinician.
- For women of child-bearing potential: willingness to abstain from sexual intercourse or use at least one form of hormonal or barrier contraception through Day 28 of the study
Key exclusion criteria (11 listed)
- Women who are pregnant or breast-feeding
- Strong clinical evidence (in the judgment of the site investigator) that the etiology of illness is primarily bacterial in origin
- Prior treatment with any investigational drug therapy within 30 days prior to screening
- History of allergic reaction to blood or plasma products (as judged by the site investigator)
- Known immunoglobulin A (IgA) deficiency
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 |
|---|---|---|
| Intravenous hyperimmune immunoglobulin (IVIG)Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight) | Biological | Arm A: hIVIG |
| Placebo for IVIGAdministered IV as 500 mL of normal saline | Biological | Arm B: Placebo |
Primary outcome
Number of Patients in Each of 6 Clinical Status Categories on Day 7
Time frame: Assessed on Day 7
This is the primary outcome, a 6-category ordinal outcome ranging from death (worst) to discharged from hospital with resumption of normal activities (best).
18 secondary outcomes
Number of Patients in Each of 5 Clinical Status Categories on Day 3
Time frame: Assessed on Day 3
Number of Patients in Each of 6 Clinical Status Categories on Day 3
Time frame: Measured on Day 3
Number of Patients With a Favorable Outcome on Day 7
Time frame: Assessed on Day 7
Hospital Discharge
Time frame: Measured through Day 7
Mortality
Time frame: Measured through day 28
Number of Patients Alive and Out of Hospital
Time frame: Measured through Day 28
Change in Viral Load
Time frame: Day 3
Death or Re-hospitalization
Time frame: Day 28
Percent of Participants Developing Complications
Time frame: Measured through Day 28
Number of Patients in Each of 6 Clinical Status Categories on Day 14
Time frame: Measured on day 14
Number of Patients Alive and Out of Hospital on Day 14
Time frame: day 14
Resumption of Normal Activities by Day 14
Time frame: day 14
Number of Patients in Each of 6 Clinical Status Categories on Day 28
Time frame: day 28
Number of Influenza A-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Time frame: Day 7
Number of Influenza B-Infected Patients in Each of 6 Clinical Status Categories on Day 7
Time frame: Day 7
pH1N1 Titers at Day 7
Time frame: Day 7
H3N2 Titers at Day 7
Time frame: Day 7
Influenza B Titers at Day 7
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37289541Vanderven HA, Wentworth DN, Han WM, Peck H, Barr IG, Davey RT Jr, Beigel JH, Dwyer DE, Jain MK, Angus B, Brandt CT, Mykietiuk A, Law MG, Neaton JD, Kent SJ; INSIGHT FLU-IVIG Study Group. Understanding the treatment benefit of hyperimmune anti-influenza intravenous immunoglobulin (Flu-IVIG) for severe human influenza. JCI Insight. 2023 Jul 24;8(14):e167464. doi: 10.1172/jci.insight.167464.
- Derived from this study: PubMed 31582358Davey RT Jr, Fernandez-Cruz E, Markowitz N, Pett S, Babiker AG, Wentworth D, Khurana S, Engen N, Gordin F, Jain MK, Kan V, Polizzotto MN, Riska P, Ruxrungtham K, Temesgen Z, Lundgren J, Beigel JH, Lane HC, Neaton JD; INSIGHT FLU-IVIG Study Group. Anti-influenza hyperimmune intravenous immunoglobulin for adults with influenza A or B infection (FLU-IVIG): a double-blind, randomised, placebo-controlled trial. Lancet Respir Med. 2019 Nov;7(11):951-963. doi: 10.1016/S2213-2600(19)30253-X. Epub 2019 Sep 30.
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Healthy Participants
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.
Richard T. Davey, Jr., MD study chair
National Institute of Allergy and Infectious Diseases (NIAID)
Eduardo Fernández-Cruz, MD, PhD study chair
Hospital General Universitario Gregorio Marañon
Norman P. Markowitz, MD study chair
The Henry Ford Hospital
21 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous hyperimmune immunoglobulin (IVIG) in people with Influenza A and Influenza B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 21 sites in 4 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 7 inclusion and 11 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 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, United Kingdom, Australia, Denmark. 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. 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 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 14 Nov 2019). 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?
Number of Patients in Each of 6 Clinical Status Categories on Day 7 (time frame: Assessed on Day 7). 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 NCT02287467, 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 14 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.