TuberculosisPhase 3NCT02623556

Clinical Study of Recombinant Mycobacterium Tuberculosis ESAT6-CFP10 Allergen

A Phase 3 study testing ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm and ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm in people with Tuberculosis, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 2 sites in China.

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Tuberculosis
What is being tested?: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm and ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,090 participants
Where: 2 sitesChina
Study dates: Dec 2015to Mar 2018
Phase: Phase 3
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

Accompanied by the following severe illness:advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
Taking part in other clinical or within three months involved in any other clinical;
Severe allergic constitution:allergic to two or more drugs;
in pregnancy or lactation;
in a mental illness;
Any conditions affect the trial evaluation by investigator's judgement.

Show all 32Show fewer

Inclusion Criteria of non-TB participants with lung disease:
A clear lung disease but can exclude pulmonary tuberculosis by clinical symptoms, imaging, laboratory examination.
18 to 65 years old, no gender limited;
Consent and signed informed consent forms (ICF);
Comply with follow-up.
Exclusion Criteria of non-TB participants with lung disease:
Accompanied by the following severe illness: advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
Taking part in other clinical or within three months involved in any other clinical;
Severe allergic constitution: allergic to two or more drugs;
in pregnancy or lactation;
in a mental illness;
history of tuberculosis;
Any conditions affect the trial evaluation by investigator's judgement.
Inclusion Criteria of suspected TB participants with lung disease:
Cases who have pulmonary tuberculosis by clinical symptoms/signs:appear cough、cough with hemoptysis、pectoralgia、dyspnea、fever（low-grade fever at afternoon）,together with night sweats、weak、loss of appetite、weight loss,and so on,or other easily-confused respiratory system disease with TB;
18 to 65 years old, no gender limited;
Consent and signed informed consent forms (ICF);
Comply with follow-up.
Exclusion Criteria of suspected TB participants with lung disease:
Accompanied by the following severe illness: advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
Taking part in other clinical or within three months involved in any other clinical;
Severe allergic constitution: allergic to two or more drugs;
in pregnancy or lactation;
in a mental illness;
history of tuberculosis;
Any conditions affect the trial evaluation by investigator's judgement.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Shanghai Public Health clinical Center
Shanghai, Shanghai Municipality
Wuxi NO.5 People's Hospital
Wuxi, Jiangsu

Other trials in China

About this study

Official title: For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase III Clinical Research

720 cases TB (Tuberculosis patients) participants、360 cases non-TB participants with lung disease and suspected TB patients who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse events.

Read the detailed description

Firstly, 720 cases TB (Tuberculosis) participants who meet the standard respectively are divided into different groups through a randomized and blind method.

ESAT6-CFP10(10ug/ml) in left arm
ESAT6-CFP10(10ug/ml) in right arm. Inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of participant, the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood pressure and temperature), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.

Secondly, 360 cases non-TB participants with lung disease and suspected TB participants are divided into two different groups and the procedure are as the same as 720 cases TB.

Thirdly,suspected TB participants are put under TB (Tuberculosis patients) or non-TB participants with lung disease by diagnosis when out group.

Finally, we calculate the sensitivity (positive coincidence rate) by TB (Tuberculosis patients), the specificity (negative coincidence rate) by non-TB participants with lung disease, and verify the safety and effectiveness of ESAT6-CFP10(10ug/ml) for the clinical auxiliary diagnosis of tuberculosis.

Conditions: Tuberculosis
Being tested: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm, ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
Keywords: diagnosis of tuberculosis, ESAT6-CFP10, skin test, diagnostic test
Medical subject headings: Tuberculosis

What participants receive

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

ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right armBiological
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left armBiological
All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.

Study groups in NCT02623556
Study group	Role	What they receive
TB subjects	Experimental	720 cases TB (Tuberculosis) subjects who meet the standard respectively are divided average into two groups through a randomized and blind method. 360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm. 360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. Receives: Biological: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm; Biological: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm
non-TB subjects with lung disease and suspected TB subjects	Experimental	360 cases non-TB subjects with lung disease and suspected TB subjects,who meet the standard respectively are divided average into different groups through a randomized and blind method. 180 non-TB subjects with lung disease are injected ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm. 180 non-TB subjects with lung disease are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. The study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. Receives: Biological: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm; Biological: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm

What is being measured

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

Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Measured: within 72h after injection
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Measured: within 72h after injection
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Measured: within 72h after injection
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Measured: within 72h after injection

Secondary outcomes (1)

Number of participants with Adverse Events
Measured: within 72h after injection two drug each participant

Timeline

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

Dec 2015Mar 2018

First posted7 Dec 2015 (estimated)
Study startDec 2015
Primary completionMar 2018
Study completionMar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for TuberculosisStudies 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: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,090 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02623556
Sponsor's protocol ID: LTao-EC III-patient
Status last verified: Jan 2017
First submitted: 3 Dec 2015
Last updated: 12 Apr 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

van Pinxteren LA, Ravn P, Agger EM, Pollock J, Andersen P. Diagnosis of tuberculosis based on the two specific antigens ESAT-6 and CFP10. Clin Diagn Lab Immunol. 2000 Mar;7(2):155-60. doi: 10.1128/CDLI.7.2.155-160.2000.
PubMed 10702486
Ravn P, Munk ME, Andersen AB, Lundgren B, Lundgren JD, Nielsen LN, Kok-Jensen A, Andersen P, Weldingh K. Prospective evaluation of a whole-blood test using Mycobacterium tuberculosis-specific antigens ESAT-6 and CFP-10 for diagnosis of active tuberculosis. Clin Diagn Lab Immunol. 2005 Apr;12(4):491-6. doi: 10.1128/CDLI.12.4.491-496.2005.
PubMed 15817755
Brusasca PN, Colangeli R, Lyashchenko KP, Zhao X, Vogelstein M, Spencer JS, McMurray DN, Gennaro ML. Immunological characterization of antigens encoded by the RD1 region of the Mycobacterium tuberculosis genome. Scand J Immunol. 2001 Nov;54(5):448-52. doi: 10.1046/j.1365-3083.2001.00975.x.
PubMed 11696195
Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS One. 2008 Apr 23;3(4):e1978. doi: 10.1371/journal.pone.0001978.
PubMed 18431468
Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P, Pollock JM. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6-CFP10 mixture shows optimal sensitivity and specificity. J Clin Microbiol. 2006 Dec;44(12):4326-35. doi: 10.1128/JCM.01184-06. Epub 2006 Sep 27.
PubMed 17005738

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 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6 - CFP10 Dose of Certain Phase III Clinical Research
ClinicalTrials.gov ID: NCT02623556
Acronym / sponsor ID: LTao-EC III-patient
Conditions: Tuberculosis
Keywords: diagnosis of tuberculosis, ESAT6-CFP10, skin test, diagnostic test
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,090 participants (estimated)
Lead sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Shanghai Public Health Clinical Center, Tianjin Haihe Hospital, Air Force Military Medical University, China, Proswell Medical Corporation, Wuhan Institute for Tuberculosis Control, Beijing Chest Hospital, Wuxi Hospital for Infectious Diseases, First Affiliated Hospital of Chongqing Medical University, Fuzhou Pulmonary Hospital of Fujian, Zhenjiang Third People's Hospital, Anhui Provincial Hospital, Shenzhen Third People's Hospital
Study start: Dec 2015
Primary completion: Mar 2018 (actual)
Study completion: Mar 2018 (actual)
First posted: 7 Dec 2015 (estimated)
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.

Detailed description

Firstly, 720 cases TB (Tuberculosis) participants who meet the standard respectively are divided into different groups through a randomized and blind method.

ESAT6-CFP10(10ug/ml) in left arm
ESAT6-CFP10(10ug/ml) in right arm. Inject intradermally ESAT6-CFP10 and TB-PPD in different arms of the same participant. For each of participant, the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe the vital signs (breathing, heart rate, blood pressure and temperature), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events.

Secondly, 360 cases non-TB participants with lung disease and suspected TB participants are divided into two different groups and the procedure are as the same as 720 cases TB.

Thirdly,suspected TB participants are put under TB (Tuberculosis patients) or non-TB participants with lung disease by diagnosis when out group.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
TB subjects	Experimental	Biological: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm, Biological: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm720 cases TB (Tuberculosis) subjects who meet the standard respectively are divided average into two groups through a randomized and blind method. 360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm. 360 TB subjects are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. For each of participant,the person in this clinical research, the study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.
non-TB subjects with lung disease and suspected TB subjects	Experimental	Biological: ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm, Biological: ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm360 cases non-TB subjects with lung disease and suspected TB subjects,who meet the standard respectively are divided average into different groups through a randomized and blind method. 180 non-TB subjects with lung disease are injected ESAT6-CFP10(10ug/ml) in left arm and TB-PPD in right arm. 180 non-TB subjects with lung disease are injected ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm. The study uniform is that every subject injects firstly left arm, observe no obvious adverse reaction, then another drug inject in right arm. Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (32 listed)

Accompanied by the following severe illness:advanced cancer, diabetes, copd in acute episodes, acute/progressive liver disease or kidney disease, congestive heart failure, ect;
Taking part in other clinical or within three months involved in any other clinical;
Severe allergic constitution:allergic to two or more drugs;
in pregnancy or lactation;
in a mental illness;

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
ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right armAll subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.	Biological	TB subjects, non-TB subjects with lung disease and suspected TB subjects
ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left armAll subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.	Biological	TB subjects, non-TB subjects with lung disease and suspected TB subjects

Primary outcome

Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
Time frame: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients
Time frame: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)
Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
Time frame: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally left arm (random injected ESAT6-CFP10 or PPD)
Immune response of right arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in non-TB subjects with lung disease
Time frame: within 72h after injection
We measure the size of induration or redness at 24h, 48h, 72h after administered intradermally right arm (random injected ESAT6-CFP10 or PPD)

1 secondary outcome

Number of participants with Adverse Events
Time frame: within 72h after injection two drug each participant

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
Background: PubMed 10702486van Pinxteren LA, Ravn P, Agger EM, Pollock J, Andersen P. Diagnosis of tuberculosis based on the two specific antigens ESAT-6 and CFP10. Clin Diagn Lab Immunol. 2000 Mar;7(2):155-60. doi: 10.1128/CDLI.7.2.155-160.2000.
Background: PubMed 15817755Ravn P, Munk ME, Andersen AB, Lundgren B, Lundgren JD, Nielsen LN, Kok-Jensen A, Andersen P, Weldingh K. Prospective evaluation of a whole-blood test using Mycobacterium tuberculosis-specific antigens ESAT-6 and CFP-10 for diagnosis of active tuberculosis. Clin Diagn Lab Immunol. 2005 Apr;12(4):491-6. doi: 10.1128/CDLI.12.4.491-496.2005.
Background: PubMed 11696195Brusasca PN, Colangeli R, Lyashchenko KP, Zhao X, Vogelstein M, Spencer JS, McMurray DN, Gennaro ML. Immunological characterization of antigens encoded by the RD1 region of the Mycobacterium tuberculosis genome. Scand J Immunol. 2001 Nov;54(5):448-52. doi: 10.1046/j.1365-3083.2001.00975.x.
Background: PubMed 18431468Weldingh K, Andersen P. ESAT-6/CFP10 skin test predicts disease in M. tuberculosis-infected guinea pigs. PLoS One. 2008 Apr 23;3(4):e1978. doi: 10.1371/journal.pone.0001978.
Background: PubMed 17005738Aagaard C, Govaerts M, Meikle V, Vallecillo AJ, Gutierrez-Pabello JA, Suarez-Guemes F, McNair J, Cataldi A, Espitia C, Andersen P, Pollock JM. Optimizing antigen cocktails for detection of Mycobacterium bovis in herds with different prevalences of bovine tuberculosis: ESAT6-CFP10 mixture shows optimal sensitivity and specificity. J Clin Microbiol. 2006 Dec;44(12):4326-35. doi: 10.1128/JCM.01184-06. Epub 2006 Sep 27.
Center for drug evaluation, CFDA, ChinaLink provided by the sponsor.
Chinese Clinical Trial RegistryLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Shuihua Lu, Bachelor principal investigator

Shanghai Public Health Clinical Center

Qi Wu, Master principal investigator

Tianjin Haihe Hospital

Weihua Wang, Doctor principal investigator

Wuhan Institute for Tuberculosis Control

2 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 0 inclusion and 32 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 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Immune response of left arm (random injected ESAT6-CFP10 or PPD) from the size of induration or redness in TB patients (time frame: within 72h after injection). The study lists 4 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 NCT02623556, which also lists 5 linked publications.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.