Hand, Foot and Mouth Disease (HFMD)Phase 4NCT03296410
The Phase IVd of Inactivated Enterovirus 71 Vaccine
A Phase 4 study testing EV71 and two measles attenuated live vaccine, EV71 and attenuated Japanese encephalitis vaccine and two measles attenuated live vaccine in people with Hand, Foot and Mouth Disease (HFMD), run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage. Read more about this study
- Who is it for?
- Ages 8 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease (HFMD)
- What is being tested?
- EV71 and two measles attenuated live vaccine, EV71 and attenuated Japanese encephalitis vaccine and two measles attenuated live vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 1 siteChina
- Study dates
- 14 Sep 2017to 2 Sep 2019
- Phase
- Phase 4
- 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 8 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy subjects (6-71 months old children) as established by medical history and clinical examination
- The subjects' legal guardian must be aware of this vaccines
- The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
- Subjects with temperature ≤ 37.0 ℃
- The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
- Persist for a 14-month visit (and receive blood, stool (or specimens by means of a swab) tests according to program requirements in immunogenicity observation group)
Who cannot join
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
- Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
Show all 17Show fewer
- Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
- Acute illness or acute exacerbation of chronic disease in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6 months
- Any prior administration of blood products in last 3 months
- Any prior administration of live-attenuated vaccine in last 15 days
- Any prior administration of subunit or inactivated vaccines in last 7 days
- Fever before vaccination, axillary temperature ﹥37.0 ℃
- The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
- Hypertension or hypotension. Systolic blood pressure ﹥140 mmHg and/ or diastolic blood pressure ﹥90 mmHg; systolic blood pressure ﹤90 mmHg and/or diastolic blood pressure ﹤60 mmHg
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- take part into other vaccine or drug clinical trials in last half year
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Province Center for Diseases Control and Prevention
Guangzhou, Guangdong, 511430
About this study
Official title: The Safety and Immunogenicity of Enterovirus Type 71 Inactivated Vaccine (Human Diploid Cell) With Two Measles Attenuated Live Vaccine and Live Attenuated Japanese Encephalitis Vaccine at the Same Time Point in Infants (8-month-old)
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.
Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old) in Guangdong Province, China.
Read the detailed description
There are two parts of phase IVd clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.
Second, to safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.
- Conditions
- Hand, Foot and Mouth Disease (HFMD)
- Being tested
- EV71 and two measles attenuated live vaccine, EV71 and attenuated Japanese encephalitis vaccine, two measles attenuated live vaccine, live attenuated Japanese encephalitis vaccine, EV71 vaccine
- Keywords
- Hand, Foot and Mouth Disease (HFMD), immunogenicity, safety
- Medical subject headings
- Hand, Foot and Mouth Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EV71 and two measles attenuated live vaccineBiological
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.
EV71 and attenuated Japanese encephalitis vaccineBiological
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.
two measles attenuated live vaccineBiological
infants vaccined with one dose two measles attenuated live vaccine at 8 months old.
live attenuated Japanese encephalitis vaccineBiological
infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.
EV71 vaccineBiological
infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).
| Study group | Role | What they receive |
|---|---|---|
| EV71 and two measles attenuated live vaccine | Experimental | infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and two measles attenuated live vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old. Receives: Biological: EV71 and two measles attenuated live vaccine |
| EV71 and attenuated Japanese encephalitis vaccine | Experimental | infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and live attenuated Japanese encephalitis vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old. Receives: Biological: EV71 and attenuated Japanese encephalitis vaccine |
| two measles attenuated live vaccine | Active comparator | infants vaccinated with two measles attenuated live vaccine at 8 months old Receives: Biological: two measles attenuated live vaccine |
| live attenuated Japanese encephalitis vaccine | Active comparator | infants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old Receives: Biological: live attenuated Japanese encephalitis vaccine |
| EV71 vaccine | Active comparator | infants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old. Receives: Biological: EV71 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Measured: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Measured: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Measured: at 0 day before finishing 1st doses immunization
Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Measured: at 0 day before finishing 1st doses immunization
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children at 56 days after first vaccination
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Measured: at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-EBV antibodies in serum of children at 56 days after first vaccination
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Measured: at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-measles virus antibodies in serum of children at 56 days after first vaccination
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Measured: at 56 days after finishing 1st doses immunization
Evaluate the seroconversion rate of anti-Rubella virus antibodies in serum of children at 56 days after first vaccination
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Measured: at 56 days after finishing 1st doses immunization
Secondary outcomes (6)
Evaluate the antibody titers of anti-EV71 antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Measured: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-EBV antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Measured: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-measles virus antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Measured: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children at 56 days.
Measured: at 56 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 1st doses immunization
The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after the 1st injection.
Measured: within 28 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 2nd doses immunization
The adverse events were observed and recorded within 30 minutes post immunization (p.i.), within 0-1 days post immunization (d.p.i.), within 1-3 d.p.i. and within 28 d.p.i. after injection.
Measured: within 28 days after finishing 2nd doses immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start14 Sep 2017
- Primary completion2 Sep 2019 (estimated)
- Study completion2 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand, Foot and Mouth Disease (HFMD)Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Center for Disease Prevention and Control
- Responsible party
- Principal investigator, Qihan Li, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296410
- Sponsor's protocol ID
- 20170710
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Immunogenicity of Enterovirus Type 71 Inactivated Vaccine (Human Diploid Cell) With Two Measles Attenuated Live Vaccine and Live Attenuated Japanese Encephalitis Vaccine at the Same Time Point in Infants (8-month-old)
- ClinicalTrials.gov ID
- NCT03296410
- Acronym / sponsor ID
- 20170710
- Conditions
- Hand, Foot and Mouth Disease (HFMD)
- Keywords
- Hand, Foot and Mouth Disease (HFMD), immunogenicity, safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,220 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Guangdong Center for Disease Prevention and Control
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 2 Sep 2019 (estimated)
- Study completion
- 2 Sep 2019 (estimated)
- First posted
- 28 Sep 2017 (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.
Enterovirus 71 (EV71), a major pathogen causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Its infection occasionally leads to severe diseases and death, with central nervous system (CNS) damage.
Recently, except of inactivated vaccine, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, such as attenuated vaccine, subunit vaccine. A formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been finished phase I, II and III clinical trials and licensed by SFDA in China at Dec. 3, 2015. Based on the results of clinical trials, the protective efficacy of inactivated EV71 vaccine is 97% against HFMD caused by EV71. The phase IV clinical trial has been carried out from July 2016. The purpose of phase IVd is to evaluated the immunogenicity and safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old) in Guangdong Province, China.
Detailed description
There are two parts of phase IVd clinical trials have been performed. First, to evaluate the immunogenicity of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.
Second, to safety of the inactive EV71 vaccine within two measles attenuated live vaccine and live attenuated Japanese encephalitis vaccine at the same time point in large scale population of Chinese children (8 months old), within 56-day-post-immunized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| EV71 and two measles attenuated live vaccine | Experimental | Biological: EV71 and two measles attenuated live vaccineinfants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and two measles attenuated live vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old. |
| EV71 and attenuated Japanese encephalitis vaccine | Experimental | Biological: EV71 and attenuated Japanese encephalitis vaccineinfants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) and live attenuated Japanese encephalitis vaccine at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old. |
| two measles attenuated live vaccine | Active comparator | Biological: two measles attenuated live vaccineinfants vaccinated with two measles attenuated live vaccine at 8 months old |
| live attenuated Japanese encephalitis vaccine | Active comparator | Biological: live attenuated Japanese encephalitis vaccineinfants vaccinated with live attenuated Japanese encephalitis vaccine at 8 months old |
| EV71 vaccine | Active comparator | Biological: EV71 vaccineinfants vaccinated with enterovirus type 71 inactivated vaccine (human diploid cell) at 8 months old, and vaccinated with the second dose of enterovirus type 71 inactivated vaccine (human diploid cell) at 9 months old. |
Who may qualify
- Ages
- 8 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy subjects (6-71 months old children) as established by medical history and clinical examination
- The subjects' legal guardian must be aware of this vaccines
- The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
- Subjects with temperature ≤ 37.0 ℃
- The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
Key exclusion criteria (17 listed)
- Allergy or serious side-effects to a vaccine or any ingredient of vaccine
- Epilepsy, seizures, convulsions, neurological illness
- Congenital or hereditary immunodeficiency
- Autoimmune disease
- Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
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 |
|---|---|---|
| EV71 and two measles attenuated live vaccineinfants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old. | Biological | EV71 and two measles attenuated live vaccine |
| EV71 and attenuated Japanese encephalitis vaccineinfants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old. | Biological | EV71 and attenuated Japanese encephalitis vaccine |
| two measles attenuated live vaccineinfants vaccined with one dose two measles attenuated live vaccine at 8 months old. | Biological | two measles attenuated live vaccine |
| live attenuated Japanese encephalitis vaccineinfants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old. | Biological | live attenuated Japanese encephalitis vaccine |
| EV71 vaccineinfants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). | Biological | EV71 vaccine |
Primary outcome
Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination
Time frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Evaluate the seropositive rate of anti-EBV antibodies in serum of children before first vaccination
Time frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Evaluate the seropositive rate of anti-measles virus antibodies in serum of children before first vaccination
Time frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Evaluate the seropositive rate of anti-Rubella virus antibodies in serum of children before first vaccination
Time frame: at 0 day before finishing 1st doses immunization
Bloods were obtained before first vaccination. The antibody titers were tested in serum of children.
Evaluate the seroconversion rate of anti-EV71 antibodies in serum of children at 56 days after first vaccination
Time frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Evaluate the seroconversion rate of anti-EBV antibodies in serum of children at 56 days after first vaccination
Time frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Evaluate the seroconversion rate of anti-measles virus antibodies in serum of children at 56 days after first vaccination
Time frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
Evaluate the seroconversion rate of anti-Rubella virus antibodies in serum of children at 56 days after first vaccination
Time frame: at 56 days after finishing 1st doses immunization
Bloods were obtained at 56 days after first vaccination. The antibody titers were tested in serum of children.
6 secondary outcomes
Evaluate the antibody titers of anti-EV71 antibodies in serum of children
Time frame: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-EBV antibodies in serum of children
Time frame: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-measles virus antibodies in serum of children
Time frame: at 56 days after finishing 1st doses immunization
Evaluate the antibody titers of anti-Rubella virus antibodies in serum of children
Time frame: at 56 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 1st doses immunization
Time frame: within 28 days after finishing 1st doses immunization
Incidence of treatment adverse events finishing 2nd doses immunization
Time frame: within 28 days after finishing 2nd doses immunization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EV71 and two measles attenuated live vaccine, EV71 and attenuated Japanese encephalitis vaccine and two measles attenuated live vaccine in people with Hand, Foot and Mouth Disease (HFMD), run by Chinese Academy of Medical Sciences at 1 site in China.
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 17 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: status not confirmed, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Evaluate the seropositive rate of anti-EV71 antibodies in serum of children before first vaccination (time frame: at 0 day before finishing 1st doses immunization). The study lists 8 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 28 Sep 2017.