Immunization; InfectionPhase 3NCT02992925

Phase 3 Study of BK1310 in Healthy Infants

A Phase 3 study testing DPT-IPV-Hib-High（Combined Vaccine）, DPT-IPV-Hib-Low（Combined Vaccine） and Hib vaccine in people with Immunization; Infection, run by Tanabe Pharma Corporation at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to: (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310. (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants. Read more about this study

Who is it for?: Ages 2 to 43 monthsHealthy volunteers can take part
Conditions the study is for: Immunization; Infection
What is being tested?: DPT-IPV-Hib-High（Combined Vaccine）, DPT-IPV-Hib-Low（Combined Vaccine） and Hib vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 370 participants
Where: 3 sitesJapan
Study dates: Nov 2016to Nov 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 2 to 43 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy infants aged ≥2 and <43 months at the first vaccination of the study drug (recommended: ≥2 and <7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
Written informed consent is obtained from a legal guardian (parent)

Who cannot join

With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
Possibility of anaphylaxis due to food or pharmaceuticals
With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination

Show all 11Show fewer

Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation
Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use)
Participated in other studies within 12 weeks before obtaining consent
With the gestational age <37 weeks or weighed less than 2500 grams at birth.
Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Study site
Fukuoka, Fukuoka
Study site
Kasuga-shi, Fukuoka
Study site
Sendai, Miyagi

Other trials in Japan

About this study

The purpose of this study is to:

(cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
(cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

Read the detailed description

Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.

Conditions: Immunization; Infection
Being tested: DPT-IPV-Hib-High（Combined Vaccine）, DPT-IPV-Hib-Low（Combined Vaccine）, Hib vaccine, DPT-IPV
Keywords: Haemophilus influenza type b, Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine, Hib, DPT-IPV
Medical subject headings: Infections, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DPT-IPV-Hib-High（Combined Vaccine）Biological
Also called BK1310-High
DPT-IPV-Hib-Low（Combined Vaccine）Biological
Also called BK1310-Low
Hib vaccineBiological
Also called ActHIB®
DPT-IPVBiological
Also called Tetrabik

Study groups in NCT02992925
Study group	Role	What they receive
Cohort 1: BK1310-High	Experimental	Not described Receives: Biological: DPT-IPV-Hib-High（Combined Vaccine）
Cohort 1: BK1310-Low	Experimental	Not described Receives: Biological: DPT-IPV-Hib-Low（Combined Vaccine）
Cohort 2: BK1310-High or -Low	Experimental	Either BK1310-High or -Low will be chosen based on the result of cohort 1 Receives: Biological: DPT-IPV-Hib-High（Combined Vaccine）; Biological: DPT-IPV-Hib-Low（Combined Vaccine）
Cohort 2: ActHIB® and Tetrabik	Active comparator	Not described Receives: Biological: Hib vaccine; Biological: DPT-IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1, 2 and 3, antibody titers (fold) >=8
Measured: 4 weeks after the primary immunization (Visit 4)

Secondary outcomes (16)

Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Measured: 4 weeks after the primary immunization (Visit 4)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Measured: 4 weeks after the booster dose (Visit 6)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （PT）
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Tetanus Toxin
Measured: 4 weeks after the primary immunization (Visit 4)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Measured: Baseline and 4 weeks after the primary immunization (Visit 4)
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) >=8
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （PT）
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin
Measured: 4 weeks after the booster dose (Visit 6)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Measured: Baseline and 4 weeks after the primary immunization (Visit 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Nov 2018

First posted14 Dec 2016 (estimated)
Study startNov 2016
Primary completionDec 2017
Study completionNov 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.
Other trials for Immunization; InfectionStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 370 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02992925
Sponsor's protocol ID: BK1310-J01
Status last verified: Dec 2025
First submitted: 1 Dec 2016
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Study of BK1310 in Healthy Infants
ClinicalTrials.gov ID: NCT02992925
Acronym / sponsor ID: BK1310-J01
Conditions: Immunization; Infection
Keywords: Haemophilus influenza type b, Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine, Hib, DPT-IPV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 370 participants (actual)
Lead sponsor: Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
Collaborators: The Research Foundation for Microbial Diseases of Osaka University
Study start: Nov 2016
Primary completion: Dec 2017 (actual)
Study completion: Nov 2018 (actual)
First posted: 14 Dec 2016 (estimated)
Results: Posted 7 Jan 2025

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:

(cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of BK1310.
(cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a control in healthy infants.

Detailed description

Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.
Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Cohort 1: BK1310-High	Experimental	Biological: DPT-IPV-Hib-High（Combined Vaccine）
Cohort 1: BK1310-Low	Experimental	Biological: DPT-IPV-Hib-Low（Combined Vaccine）
Cohort 2: BK1310-High or -Low	Experimental	Biological: DPT-IPV-Hib-High（Combined Vaccine）, Biological: DPT-IPV-Hib-Low（Combined Vaccine）Either BK1310-High or -Low will be chosen based on the result of cohort 1
Cohort 2: ActHIB® and Tetrabik	Active comparator	Biological: Hib vaccine, Biological: DPT-IPV

Who may qualify

Ages: 2 to 43 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy infants aged ≥2 and <43 months at the first vaccination of the study drug (recommended: ≥2 and <7 months). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions.
Written informed consent is obtained from a legal guardian (parent)

Key exclusion criteria (11 listed)

With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency
Possibility of anaphylaxis due to food or pharmaceuticals
With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.

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
DPT-IPV-Hib-High（Combined Vaccine）Also: BK1310-High	Biological	Cohort 1: BK1310-High, Cohort 2: BK1310-High or -Low
DPT-IPV-Hib-Low（Combined Vaccine）Also: BK1310-Low	Biological	Cohort 1: BK1310-Low, Cohort 2: BK1310-High or -Low
Hib vaccineAlso: ActHIB®	Biological	Cohort 2: ActHIB® and Tetrabik
DPT-IPVAlso: Tetrabik	Biological	Cohort 2: ActHIB® and Tetrabik

Primary outcome

Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Time frame: 4 weeks after the primary immunization (Visit 4)
Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1, 2 and 3, antibody titers (fold) >=8

16 secondary outcomes

Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 4)
Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 6)

Results and safety

Results posted to the registry on 7 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BK1310-High	15	15
BK1310-Low	15	15
BK1310	0	0
ActHIB® and Tetrabik (Control)	0	0

Primary outcome: Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP

Time frame: 4 weeks after the primary immunization (Visit 4). Number (95% Confidence Interval). Unit: percentage of participants

Measure	BK1310-High n = 15	BK1310-Low n = 15	BK1310 n = 170	ActHIB® and Tetrabik (Control) n = 165
Antibody prevalence rate against anti-PRP with 1 μg/mL or higher	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (97.9 to 100.0)	93.3 (88.4 to 96.6)
Antibody prevalence rate against diphtheria toxin	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	97.6 (94.1 to 99.4)	98.8 (95.6 to 99.9)
Antibody prevalence rate against pertussis （PT）	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	99.4 (96.8 to 100.0)	100.0 (97.8 to 100.0)
Antibody prevalence rate against pertussis (FHA)	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	97.6 (94.1 to 99.4)	99.4 (96.6 to 100.0)
Antibody prevalence rate against tetanus toxin	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (97.9 to 100.0)	100.0 (97.8 to 100.0)
Antibody prevalence rate against polio virus serotype 1	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (97.9 to 100.0)	100.0 (97.7 to 100.0)
Antibody prevalence rate against polio virus serotype 2	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (97.9 to 100.0)	100.0 (97.7 to 100.0)
Antibody prevalence rate against polio virus serotype 3	100.0 (78.2 to 100.0)	100.0 (78.2 to 100.0)	100.0 (97.9 to 100.0)	100.0 (97.7 to 100.0)

Population analysed: For antibody analysis at Visit 4, number of subjects decreased from 370 to 365. BK1310 group: due to physician decision (n=1).Control group: due to withdrawal by parent/guardian (n=2) and deviation in blood collection timing (n=2). In control group number of subjects further decreased due to insufficient sample volume (diphtheria: n=2, PT: n=1, FHA: n=1, tetanus: n=1, polio serotype1: n=5, polio serotype2: n=4, polio serotype3: n=4）

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BK1310-High	1 of 15 (6.7%)	15 of 15 (100%)	0 of 15
BK1310-Low	0 of 15 (0%)	15 of 15 (100%)	0 of 15
BK1310	8 of 171 (4.7%)	162 of 171 (94.7%)	0 of 171
ActHIB® and Tetrabik (Control)	5 of 169 (3%)	163 of 169 (96.4%)	0 of 169

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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.

General Manager study director

Tanabe Pharma Corporation

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 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 7 Jan 2025). 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?

Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP (time frame: 4 weeks after the primary immunization (Visit 4)). 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 NCT02992925.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.