Influenza InfectionPhase 2NCT02555618
Phase 2 Study of TAK-850 in Comparison With Influenza Hemagglutinin (HA) Vaccine in Healthy Adult Participants
A Phase 2 study testing TAK-850 and Influenza HA vaccine in people with Influenza Infection, run by Takeda.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Infection
- What is being tested?
- TAK-850 and Influenza HA vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Dec 2015
- Phase
- Phase 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
- The participant is a healthy Japanese adult male or female.
- The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
- The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m^2, inclusive, at the time of the eligibility evaluation.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agreed to routinely use adequate contraception from signing of the informed consent throughout the duration of the study.
Who cannot join
- The participant has received any investigational compound within 4 months prior to injection of study vaccine.
- The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to injection of study vaccine.
- The participant has a history of influenza infection within 6 months prior to injection of study vaccine.
- The participant has been vaccinated with TAK-850 before.
- The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
- The participant has uncontrolled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, endocrine, or other disorders, which may impact the ability of the participant to participate or potentially confound the study results.
Show all 23Show fewer
- The participant has an oral temperature >= 37.5 °C prior to injection of study vaccine on Day 1.
- The participant has any medically diagnosed or suspected immune deficient condition.
- The participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to injection of study vaccine. Such treatments include systemic or high dose inhaled corticosteroids (> 800 µg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation therapy, and other immunosuppressive and cytotoxic drugs.
- The participant has received antipyretics within 4 hours prior to the injection of study vaccine.
- The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis [ADEM] and multiple sclerosis), or convulsions.
- The participant has a functional or surgical asplenia.
- The participant has a rash, other dermatologic conditions, or tattoos which may interfere with the evaluation of injection site reaction.
- The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- The participant has known hypersensitivity to any component of TAK-850 or Influenza HA Vaccine.
- The participant has a history of severe allergic reactions or anaphylaxis.
- The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to injection of study vaccine or is unwilling to agree to abstain from excessive alcohol and drugs throughout the study.
- The participant has received any blood products (blood transfusion or immunoglobulin) within 90 days prior to injection of study vaccine.
- The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to injection of study vaccine.
- If female, the participant is pregnant or lactating or intending to become pregnant before signing of informed consent, during treatment, or within 12 weeks after injection of study vaccine; or intending to donate ova during this time period.
- The participant has donated whole blood >= 200 mL within 4 weeks (28 days), >= 400 mL within 12 weeks (84 days), >= 800 mL within 52 weeks (364 days) or blood components within 2 weeks (14 days) prior to injection of study vaccine.
- The participant has abnormal laboratory values that suggest a clinically significant underlying disease at the assessment prior to the injection of study vaccine, or the participant has the following laboratory abnormalities: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than 3 times the respective upper limits of normal.
- In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reasons.
About this study
Official title: A Randomized Double-Blind Parallel-Group Comparative Phase 2 Study to Evaluate the Immunogenicity and Safety of a Single Subcutaneous Injection of TAK-850 in Comparison With Influenza HA Vaccine in Healthy Adult Subjects
The purpose of this study is to evaluate the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.
Read the detailed description
This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV.
The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine.
The study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- TAK-850
- Influenza HA vaccine All participants received one injection. This single center trial was conducted in Japan. The overall time to participate in this study was 22 days. Participants made multiple visits to the clinic, including a final visit 21 days after the vaccination for a follow-up assessment.
- Conditions
- Influenza Infection
- Being tested
- TAK-850, Influenza HA vaccine
- Keywords
- Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-850Biological
TAK-850 subcutaneous injection
Influenza HA vaccineBiological
Influenza HA vaccine subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| TAK-850 | Experimental | A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm. Receives: Biological: TAK-850 |
| Influenza HA Vaccine | Active comparator | A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. Receives: Biological: Influenza HA vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10.
Measured: Baseline and Day 22
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Secondary outcomes (17)
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
Geometric mean fold increase in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Measured: Baseline and Day 22
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, as measured by single radial hemolysis (SRH) antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination.
Measured: Baseline and Day 22
GMT of SRH Antibody Titer (Egg-Derived Antigen)
GMT of SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
Geometric mean fold increase in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Measured: Baseline and Day 22
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline HI antibody titer of ≥10 achieving a minimal 4-fold increase, or a Baseline HI antibody titer of <10 achieving a HI antibody titer of ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Measured: Baseline and Day 22
GMT of HI Antibody Titer (Vero-Derived Antigen)
GMT of HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with HI antibody titer ≥40, was measured by HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
Geometric mean fold increase in HI antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Measured: Baseline and Day 22
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
Seroconversion rate, defined as the percentage of participants with a Baseline SRH antibody titer of >4 mm^2 achieving a minimal 50% increase, or a Baseline SRH antibody titer of ≤4 mm^2 achieving a SRH antibody titer of ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination.
Measured: Baseline and Day 22
GMT of SRH Antibody Titer (Vero-Derived Antigen)
GMT of SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
Seroprotection rate, defined as the percentage of participants with SRH antibody titer ≥25 mm^2, was measured by SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination. Day 1 data is reported for reference.
Measured: Days 1 and 22
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
Geometric mean fold increase in SRH antibody titer (Vero-derived antigen) for each of the three strains, 21 days after vaccination, as compared with Baseline.
Measured: Baseline and Day 22
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
Measured: 22 Days
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: 22 days
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Measured: 22 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionDec 2015
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.
- Other trials for Influenza InfectionStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555618
- Sponsor's protocol ID
- TAK-850/CPH-003
- Other IDs
- U1111-1174-1290, JapicCTI-153019
- Status last verified
- Nov 2016
- First submitted
- 17 Sep 2015
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Parallel-Group Comparative Phase 2 Study to Evaluate the Immunogenicity and Safety of a Single Subcutaneous Injection of TAK-850 in Comparison With Influenza HA Vaccine in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02555618
- Acronym / sponsor ID
- TAK-850/CPH-003
- Conditions
- Influenza Infection
- Keywords
- Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Sep 2015 (estimated)
- Results
- Posted 29 Dec 2016
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 the immunogenicity and safety of TAK-850 administered subcutaneously as a single dose versus influenza HA vaccination in an exploratory manner.
Detailed description
This study is a phase 2, single dose study of TAK-850 (cell-culture derived TIV) administered subcutaneously in healthy Japanese adults, designed as a randomized, double-blind, parallel-group, comparative study to evaluate the immunogenicity and safety compared to an egg-derived TIV.
The drug being tested in this study is called TAK-850. TAK-850 was tested in healthy volunteers. This study looked at immunogenicity and safety of TAK-850 (cell-derived) compared to an egg-derived influenza vaccine.
The study enrolled 400 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- TAK-850
- Influenza HA vaccine All participants received one injection. This single center trial was conducted in Japan. The overall time to participate in this study was 22 days. Participants made multiple visits to the clinic, including a final visit 21 days after the vaccination for a follow-up assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-850 | Experimental | Biological: TAK-850A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm. |
| Influenza HA Vaccine | Active comparator | Biological: Influenza HA vaccineA single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm. |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- In the opinion of the investigator or subinvestigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
- The participant is a healthy Japanese adult male or female.
- The participant is aged 20 to 49 years, inclusive, at the time of informed consent.
- The participant has a body mass index (BMI) between 18.5 and 25.0 kg/m^2, inclusive, at the time of the eligibility evaluation.
Key exclusion criteria (23 listed)
- The participant has received any investigational compound within 4 months prior to injection of study vaccine.
- The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to injection of study vaccine.
- The participant has a history of influenza infection within 6 months prior to injection of study vaccine.
- The participant has been vaccinated with TAK-850 before.
- The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
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 |
|---|---|---|
| TAK-850TAK-850 subcutaneous injection | Biological | TAK-850 |
| Influenza HA vaccineInfluenza HA vaccine subcutaneous injection | Biological | Influenza HA Vaccine |
Primary outcome
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen)
Time frame: Baseline and Day 22
Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10.
Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
Time frame: Days 1 and 22
Geometric mean titer (GMT) of HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
17 secondary outcomes
Seroprotection Rate of HI Antibody Titer (Egg-Derived Antigen)
Time frame: Days 1 and 22
Geometric Mean Fold Increase in HI Antibody Titer (Egg-Derived Antigen)
Time frame: Baseline and Day 22
Seroconversion Rate of Single Radial Hemolysis (SRH) Antibody Titer (Egg-Derived Antigen)
Time frame: Baseline and Day 22
GMT of SRH Antibody Titer (Egg-Derived Antigen)
Time frame: Days 1 and 22
Seroprotection Rate of SRH Antibody Titer (Egg-Derived Antigen)
Time frame: Days 1 and 22
Geometric Mean Fold Increase in SRH Antibody Titer (Egg-Derived Antigen)
Time frame: Baseline and Day 22
Seroconversion Rate of HI Antibody Titer (Vero-Derived Antigen)
Time frame: Baseline and Day 22
GMT of HI Antibody Titer (Vero-Derived Antigen)
Time frame: Days 1 and 22
Seroprotection Rate of HI Antibody Titer (Vero-Derived Antigen)
Time frame: Days 1 and 22
Geometric Mean Fold Increase in HI Antibody Titer (Vero-Derived Antigen)
Time frame: Baseline and Day 22
Seroconversion Rate of SRH Antibody Titer (Vero-Derived Antigen)
Time frame: Baseline and Day 22
GMT of SRH Antibody Titer (Vero-Derived Antigen)
Time frame: Days 1 and 22
Seroprotection Rate of SRH Antibody Titer (Vero-Derived Antigen)
Time frame: Days 1 and 22
Geometric Mean Fold Increase in SRH Antibody Titer (Vero-Derived Antigen)
Time frame: Baseline and Day 22
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Time frame: 22 Days
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time frame: 22 days
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Time frame: 22 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-850 and Influenza HA vaccine in people with Influenza Infection, run by Takeda.
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 6 inclusion and 23 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 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 29 Dec 2016). 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?
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) (time frame: Baseline and Day 22). The study lists 2 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 29 Dec 2016.