InfluenzaPhase 1/2MEDI8852NCT02603952
A Phase 2a to Evaluate the Safety of MEDI8852 in Adults With Uncomplicated Influenza
A Phase 1/2 study testing Oseltamivir and MEDI8852 in people with Influenza, run by MedImmune LLC at 31 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza
- What is being tested?
- Oseltamivir and MEDI8852
- 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
- 126 participants
- Where
- 31 sitesin 2 countries
- Study dates
- 7 Dec 2015to 9 Dec 2016
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 through 65 years at the time of screening.
- Symptomatic presumptive Influenza A infection with onset of symptoms less than or equal to (≤) 5 days prior to MEDI8852 administration and defined as the presence of:
- Fever of greater than or equal to (≥) 38.0 degrees Celsius (100.4 degrees Fahrenheit) at screening AND
- ≥ 1 moderate systemic symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) AND
- ≥ 1 moderate respiratory symptom (cough, sore throat, or nasal symptoms)
- Influenza A infection confirmed with positive rapid antigen test
- Able to complete the follow-up period through Day 101 as required by protocol (including telephone follow-up for Days 11 to 101)
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use a highly effective method of contraception for at least 2 days prior to the first dose of investigational product and must agree to continue using such precautions through Day 101 of the study
Who cannot join
- Hospitalized subjects.
- Receipt of influenza antiviral therapy within the preceding 14 days.
- Receipt of immunoglobulin or blood products within 6 months prior to screening.
- Known immunodeficiency due to illness, including human immunodeficiency virus (HIV), or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
- Current clinical evidence of pneumonia.
- Active bacterial infection requiring treatment with oral or parenteral antibiotics.
- History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 3 years.
- Any planned surgical procedure before completion of Day 101.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States22 sites
Research Site
Avon, Indiana, 46123
Research Site
Butte, Montana, 59701
Research Site
Canoga Park, California, 91303
Research Site
Clinton, Utah, 84015
Research Site
Hialeah, Florida, 33012
Research Site
Hialeah, Florida, 33013
Research Site
Hialeah, Florida, 33016
Research Site
Hickory, North Carolina, 28602
Research Site
Long Beach, California, 90806
Research Site
Los Angeles, California, 90017
Research Site
Miami, Florida, 33165
Research Site
Miami, Florida, 33173
Research Site
Miami, Florida, 33185
Research Site
Miami Lakes, Florida, 33014
Research Site
Muncie, Indiana, 47304
Research Site
New Orleans, Louisiana, 70124
Research Site
North Miami Beach, Florida, 33162
Research Site
San Antonio, Texas, 78229
Research Site
Shelby, North Carolina, 28150
Research Site
Smithfield, Pennsylvania, 15478
Research Site
Troy, Michigan, 48085
Research Site
Upland, California, 91786
South Africa9 sites
Research Site
Durban, 4001
Research Site
Johannesburg, 2113
Research Site
Pretoria, 0087
Research Site
Pretoria, 0157
Research Site
Pretoria, 0181
Research Site
Pretoria, 0183
Research Site
Thabazimbi, 0380
Research Site
Welkom, 9460
Research Site
Winnie Mandela, 9400
About this study
Official title: A Phase 2a, Randomized, Partial Double-blind, Single Dose, Active-controlled, Dose Ranging Study to Evaluate the Safety of MEDI8852 in Adults With Acute, Uncomplicated Influenza
The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.
Read the detailed description
The MEDI8852 phase 2a study will evaluate the safety and tolerability of a single intravenous (IV) dose of MEDI8852 administered in conjunction with oseltamivir, the safety and tolerability of oseltamivir alone and the safety and tolerability of a single IV dose of MEDI8852 alone in adult participants with confirmed acute, uncomplicated influenza caused by Type A strains. Enrollment is planned in the United States, South Africa, and Australia.
- Conditions
- Influenza
- Being tested
- Oseltamivir, MEDI8852, Placebo
- Keywords
- Influenza, Influenza A, Flu, Flu A
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OseltamivirDrug
75 mg capsules orally BID from Day 1 to Day 5.
MEDI8852Drug
MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.
PlaceboDrug
Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Oseltamivir 75 mg | Placebo comparator | Participants will receive a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. Receives: Drug: Oseltamivir; Drug: Placebo |
| MEDI8852 750 mg + Oseltamivir 75 mg | Experimental | Participants will receive a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. Receives: Drug: Oseltamivir; Drug: MEDI8852 |
| MEDI8852 3000 mg + Oseltamivir 75 mg | Experimental | Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. Receives: Drug: Oseltamivir; Drug: MEDI8852 |
| MEDI8852 3000 mg | Experimental | Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1. Receives: Drug: MEDI8852 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Measured: Day 1 (post-dose) through Day 10
Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Measured: Day 10 through Day 13
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Day 1 (post-dose) through Day 28
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.
Measured: Day 1 (post-dose) through Day 101
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)
An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.
Measured: Day 1 (post-dose) through Day 101
Secondary outcomes (6)
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Quantitative real-time polymerase chain reaction (qRT-PCR) was used to measure influenza viral shedding from the nasopharyngeal swabs. Percentage of participants who shed influenza virus are reported.
Measured: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Measured: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
Number of Days of Influenza Viral Shedding as Measured by qRT-PCR
Number of days of viral shedding for participants who shed influenza virus is reported. qRT-PCR was used to measure influenza viral shedding from the nasopharyngeal swabs.
Measured: From Baseline (Day 1) to Day 7; and Day 9 to Day 13
Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site
Genotypic analysis was performed to identify all amino acid changes in MEDI8852 binding site between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with changes in the amino acid corresponding to MEDI8852 binding site is reported. Due to the fact that the percentage of participants with amino acid changes in MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Measured: From Baseline (Day 1) to Day 13
Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay
Viral susceptibility to MEDI8852 was measured by a Madin-Darby canine kidney (MDCK) cell-based microneutralization assay (Virospot) for viruses recovered from baseline samples and viruses recovered from samples following treatment that contain amino acid changes within the MEDI8852 binding site. Participants with detectable levels (50% tissue culture infectious dose [TCID50]) of virus were considered susceptible and were reported. Due to the fact that the number of participants with viral susceptibility to MEDI8852 binding site was zero across all participant samples analyzed, no additional per arm analyses were performed.
Measured: From Baseline (Day 1) to Day 13
Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations
Genotypic analysis was performed to identify all amino acid changes in neuraminidase (NA) gene between each baseline (Day1) sample and the participant's corresponding last sample sequenced. Percentage of participants with virus containing known oseltamivir resistance-associated mutations (change in the NA genes) is reported. Due to the fact that the percentage of participants with virus containing known oseltamivir resistance-associated mutation was zero across all participant samples analyzed, no additional per arm analyses were performed.
Measured: From Baseline (Day 1) to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start7 Dec 2015
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
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 (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603952
- Sponsor's protocol ID
- D6000C00002
- Acronym
- MEDI8852
- Status last verified
- May 2018
- First submitted
- 2 Nov 2015
- Last updated
- 8 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ali SO, Takas T, Nyborg A, Shoemaker K, Kallewaard NL, Chiong R, Dubovsky F, Mallory RM. Evaluation of MEDI8852, an Anti-Influenza A Monoclonal Antibody, in Treating Acute Uncomplicated Influenza. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e00694-18. doi: 10.1128/AAC.00694-18. Print 2018 Nov.
PubMed 30150460
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Partial Double-blind, Single Dose, Active-controlled, Dose Ranging Study to Evaluate the Safety of MEDI8852 in Adults With Acute, Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT02603952
- Acronym / sponsor ID
- MEDI8852 / D6000C00002
- Conditions
- Influenza
- Keywords
- Influenza, Influenza A, Flu, Flu A
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Posted 8 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and tolerability of a single dose of MEDI8852 when given with oseltamivir, the safety and tolerability of oseltamivir alone, and the safety and tolerability of a single dose of MEDI8852 alone in adult participants with acute, uncomplicated influenza caused by Type A strains.
Detailed description
The MEDI8852 phase 2a study will evaluate the safety and tolerability of a single intravenous (IV) dose of MEDI8852 administered in conjunction with oseltamivir, the safety and tolerability of oseltamivir alone and the safety and tolerability of a single IV dose of MEDI8852 alone in adult participants with confirmed acute, uncomplicated influenza caused by Type A strains. Enrollment is planned in the United States, South Africa, and Australia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo + Oseltamivir 75 mg | Placebo comparator | Drug: Oseltamivir, Drug: PlaceboParticipants will receive a single intravenous (IV) infusion of placebo (matched to MEDI8852) on Day 1 and oseltamivir 75 milligrams (mg) capsules orally twice a day (BID) from Day 1 to Day 5. |
| MEDI8852 750 mg + Oseltamivir 75 mg | Experimental | Drug: Oseltamivir, Drug: MEDI8852Participants will receive a single IV infusion of MEDI8852 750 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
| MEDI8852 3000 mg + Oseltamivir 75 mg | Experimental | Drug: Oseltamivir, Drug: MEDI8852Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1 and oseltamivir 75 mg capsules orally BID from Day 1 to Day 5. |
| MEDI8852 3000 mg | Experimental | Drug: MEDI8852Participants will receive a single IV infusion of MEDI8852 3000 mg on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 through 65 years at the time of screening.
- Symptomatic presumptive Influenza A infection with onset of symptoms less than or equal to (≤) 5 days prior to MEDI8852 administration and defined as the presence of:
- Fever of greater than or equal to (≥) 38.0 degrees Celsius (100.4 degrees Fahrenheit) at screening AND
- ≥ 1 moderate systemic symptom (headache, malaise, myalgia, sweats and/or chills, or fatigue) AND
- ≥ 1 moderate respiratory symptom (cough, sore throat, or nasal symptoms)
Key exclusion criteria (8 listed)
- Hospitalized subjects.
- Receipt of influenza antiviral therapy within the preceding 14 days.
- Receipt of immunoglobulin or blood products within 6 months prior to screening.
- Known immunodeficiency due to illness, including human immunodeficiency virus (HIV), or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
- Current clinical evidence of pneumonia.
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 |
|---|---|---|
| Oseltamivir75 mg capsules orally BID from Day 1 to Day 5. | Drug | MEDI8852 3000 mg + Oseltamivir 75 mg, MEDI8852 750 mg + Oseltamivir 75 mg, Placebo + Oseltamivir 75 mg |
| MEDI8852MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1. | Drug | MEDI8852 3000 mg, MEDI8852 3000 mg + Oseltamivir 75 mg, MEDI8852 750 mg + Oseltamivir 75 mg |
| PlaceboPlacebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1. | Drug | Placebo + Oseltamivir 75 mg |
Primary outcome
Number of Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10
Time frame: Day 1 (post-dose) through Day 10
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Number of Participants With Any Solicited Influenza Symptoms From Day 10 Through Day 13
Time frame: Day 10 through Day 13
Solicited influenza symptoms included cough, nasal congestion, sore throat, aches and pains, fatigue (tiredness), headache, chills/sweats (feeling feverish).
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 (post-dose) through Day 28
An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent events were between administration of study drug and Day 28 that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 (post-dose) through Day 101
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre-treatment state.
Number of Participants With Treatment Emergent Adverse Events of Special Interest (TEAESIs)
Time frame: Day 1 (post-dose) through Day 101
An AE is any untoward medical occurrence attributed to study drug in a participant who received study drug. An AESI was one of scientific and medical interest specific to understanding of the study drug and may have required close monitoring and rapid communication by the investigator to the sponsor. Treatment-emergent events were between administration of study drug and Day 101 that were absent before treatment or that worsened relative to pre treatment state.
6 secondary outcomes
Percentage of Participants With Influenza Viral Shedding as Measured by Quantitative Reverse Transcription-Polymerase Chain Reaction (qRT-PCR)
Time frame: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
Quantitation of Influenza Viral Shedding as Measured by qRT-PCR
Time frame: Baseline (Day 1) and Days 3, 5, 7, 9, 11, and 13
Number of Days of Influenza Viral Shedding as Measured by qRT-PCR
Time frame: From Baseline (Day 1) to Day 7; and Day 9 to Day 13
Percentage of Participants With Amino Acid Changes in MEDI8852 Binding Site
Time frame: From Baseline (Day 1) to Day 13
Number of Participants With Viral Susceptibility to MEDI8852 as Determined by a Cell Based Microneutralization Assay
Time frame: From Baseline (Day 1) to Day 13
Percentage of Participants With Virus Containing Known Oseltamivir Resistance-Associated Mutations
Time frame: From Baseline (Day 1) to Day 13
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30150460Ali SO, Takas T, Nyborg A, Shoemaker K, Kallewaard NL, Chiong R, Dubovsky F, Mallory RM. Evaluation of MEDI8852, an Anti-Influenza A Monoclonal Antibody, in Treating Acute Uncomplicated Influenza. Antimicrob Agents Chemother. 2018 Oct 24;62(11):e00694-18. doi: 10.1128/AAC.00694-18. Print 2018 Nov.
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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.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oseltamivir and MEDI8852 in people with Influenza, run by MedImmune LLC at 31 sites in 2 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 8 inclusion and 8 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, South Africa. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 8 Jun 2018). 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 Participants With Any Solicited Influenza Symptoms From Day 1 Through Day 10 (time frame: Day 1 (post-dose) through Day 10). The study lists 5 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 NCT02603952, which also lists 1 linked publication.
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 8 Jun 2018.