BerylliosisPhase 1/2BISCITNCT00111917
Beryllium Infliximab Study: Clinical Interventional Trial
A Phase 1/2 study testing Infliximab in people with Berylliosis and Beryllium Disease, run by Maier, Lisa, M.D. at 1 site in United States.
Trial summary
The goal of this research study is to test the clinical effectiveness of a drug called infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the lung. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Berylliosis, Beryllium Disease
- What is being tested?
- Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2009
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-80.
- Noncaseating granulomas and/or mononuclear cell infiltrates demonstrated on transbronchial lung biopsy.
- Abnormal blood and/or BAL BeLPT results.
- Current treatment with prednisone and/or methotrexate specifically for CBD and not any other condition, at any range of dosage, for at least 6 months prior to enrollment, and on a stable dosage for at least 1 month prior to first infusion.
- Moderate CBD severity, such that participants can safely undergo bronchoscopy with BAL including PaO2 >= 50 mmHg on room air (at Denver altitude of 5,280 ft).
- Availability to come back to National Jewish Medical and Research Center for infusions, evaluations, and follow-ups.
- Capable of providing informed consent.
- Willing and able to adhere to the study visit schedule and other protocol-specified procedures.
Who cannot join
- Positive tuberculosis (TB) skin test upon screening: An intradermal tuberculin skin test must be performed within 1 month prior to the first administration of study agent.
- Any evidence of TB.
- Considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules.
- Positive pregnancy test.
- Women who are pregnant, nursing, or planning pregnancy within one year after screening
- Contraindications to bronchoscopy and BAL such as bleeding diathesis, PaO2 <50 mmHg on room air, evidence of acute infection, hemodynamic instability with labile blood pressure, either <90/60 or >160/110, untreated coronary artery disease, or other medical reason for which a subject will not be able to safely undergo bronchoscopy.
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- Positive cultures from prior BAL indicating mycobacterial or fungal infection.
- Positive special stains for acid fast bacilli (AFB) or fungi on prior lung biopsies.
- Known atypical mycobacterium infection.
- Clinical evidence of active infection at time of enrollment.
- Serious acute infections (e.g., viral hepatitis, pneumonia or pyelonephritis) in the previous 3 months.
- Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
- Documented HIV infection.
- Positive serology for active hepatitis B or C. A positive result will indicate the need for referral to a consultant Hepatologist for further investigation and support.
- Use of any investigational drug within 1 month prior to screening or within 5 half lives of the investigational agent, whichever is longer.
- Treatment with any other therapeutic agent targeted at reducing TNF-a (e.g. pentoxifylline, thalidomide, etanercept, etc.) within 3 months of screening.
- Prior use of Enbrel® or Humera®.
- Previous administration of infliximab.
- Known allergy to murine (mouse) products.
- Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
- Any history of congestive heart failure, severe right sided heart failure, or cor pulmonale.
- Presence of a transplanted organ (with the exception of a corneal transplant > 3 months prior to screening).
- Major surgery in the previous 3 months.
- Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
- History of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or perioaortic areas), or splenomegaly.
- Known recent substance abuse (drug or alcohol).
- Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Remicade in Chronic Beryllium Disease: A Randomized, Double-Blind, Placebo-Controlled, Investigator Initiated Trial
The goal of this research study is to test the clinical effectiveness of a drug called infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the lung. Receiving infliximab may help with symptoms, and may improve clinical testing data normally ordered by your doctor, such as breathing tests. Baseline and follow-up testing will look for improvements in breathing tests (pulmonary function testing), exchange of oxygen in the lungs (exercise test), chest x ray, and lung inflammation.
Read the detailed description
Hypothesis:
The central hypothesis of this study is that infliximab will prove to be efficacious in the treatment of chronic beryllium disease (CBD), and that it will do so by inhibiting beryllium specific T cell proliferation and cytokine production.
Specific Aims:
Specific Aim 1: To determine the clinical effectiveness of infliximab on chronic beryllium disease. The efficacy of infliximab will be measured by improvement in arterial gas exchange, or arterial alveolar oxygen gradient (A-ad02) at end exercise in subjects with CBD who remain symptomatic and with pulmonary impairment despite current treatment with prednisone and/or methotrexate. Secondary outcome measures will include change in airflow, lung volume, diffusing capacity (DLCO), profusion of small opacities on chest x-ray, dyspnea score, and quality of life questionnaires.
Specific Aim 2: To determine the effect of infliximab on intermediate markers of biological function in CBD. In vitro studies will examine the effect of infliximab on blood and lung cells in culture, as measured by a decrease in beryllium (Be)-stimulated lymphocyte proliferation; a decrease in Be-stimulated cytokine production, including TNF-a, IFN-g, and IL-2; altered Be-stimulated apoptosis of macrophages or lymphocytes.
Research Design and Methods: Since no information is available regarding the pharmacokinetics of infliximab in patients with CBD, the pharmacokinetic information available from the use of infliximab in other similar inflammatory conditions formed the basis for selecting the dose regimen for this protocol. Particularly, a 5mg/kg dose will be used for this study, based on the dose selection used in the sarcoidosis protocol C0168T48 presently underway in a multi-center trial (NJC IRB HS-1771).
This is an investigator initiated, 40 week, randomized, double-blind, placebo controlled study to evaluate the efficacy of infliximab dosed at 5mg/kg, compared to placebo, in individuals with symptomatic CBD with pulmonary involvement despite prednisone and/or methotrexate treatment. Infliximab or placebo will be infused at weeks 0, 2, 6, 12, 18, and 24 including spirometry, lung volumes and DLCO. Approximately 20 participants will be enrolled in the study at National Jewish Medical and Research Center at a 3:1 drug: placebo rate.
The primary endpoint of this study will be a change from baseline testing to week 28 testing in the A-adO2 at end exercise on a 6 minute walk. At baseline evaluation, subjects will undergo full pulmonary function testing, a blood draw for the beryllium lymphocyte proliferation test (BeLPT), 6 minute walk, chest x-ray, and quality of life and dyspnea questionnaires. Follow-up full pulmonary function testing, rest and end exercise A-ad02, pulse oximetry with total distance (workload) achieved on a 6 minute walk, and chest radiograph will be measured at week 12. Final outcome measurements (same as baseline testing), including bronchoscopy with BAL, will be repeated at week 28. A follow-up appointment will be scheduled at week 40 to assess patients' general health, as well as measure rest and end exercise A-ad02 and pulse oximetry with 6 minute walk, pulmonary function test, QOL/dyspnea scoring, and chest radiograph interstitial lung opacity profusion score.
The effects of infliximab on the Be-stimulated immune response will be assessed by comparing the following markers before and after infliximab therapy: 1. BeLPT from blood and lavage cells (BAL); 2. Be-stimulated cytokine production from BAL cells including TNF-a, IFN-γ, and IL-2; 3. Cell-specific apoptosis. The assay will include an unstimulated control, 100 mM BeSO4, 100 mM Al2(SO4)3 metal-salt control, PHA - lymphocyte proliferation control, infliximab control, infliximab + BeSO4, infliximab + Al2(SO4)3. At days 4, 5, and 6 after Be exposure, the wells are pulsed with the DNA-specific precursor, 3H-TdR, incubated for four hours, harvested on glass fiber filters, and liquid scintillation methods are used for counting. Results are reported as a stimulation index, which is a ratio of the counts per minute of the treatment group to the counts per minute of the unstimulated group. To determine the effect of infliximab on cytokine production, CBD BAL and CBD PBMC will be stimulated with Be for 24 hours. ELISA will be used to determine TNF-α, IFN-γ, and IL-2 supernatant levels. After 24 hours of beryllium exposure, we will harvest supernatants and perform ELISA testing for TNF-α, IFN-γ, and IL-2. In order to determine if infliximab causes an increase in lymphocyte or macrophage apoptosis, CBD BAL cells will be cultured for 24 hours with Be. Cells will be double stained for CD4+ (Th1) and CD71+ macrophages versus intracellular activated caspase-3, caspase-8 and caspase-9. These in vitro studies will be used to assess the potential biologic function of infliximab on immune mediated diseases using a disease model with known antigen, CBD.
- Conditions
- Berylliosis, Beryllium Disease
- Being tested
- Infliximab, Placebo
- Keywords
- Chronic Beryllium Disease, Berylliosis, Beryllium Disease, CBD, Infliximab
- Medical subject headings
- Berylliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Remicade
anti-TNF
PlaceboOther
Placebo infusion
| Study group | Role | What they receive |
|---|---|---|
| Infliximab | Experimental | infusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks. Receives: Drug: Infliximab |
| Placebo | Placebo comparator | infusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A-a Gradient at End Exercise
change in end-exercise A-a gradient
Measured: after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2005 (estimated)
- Study startFeb 2005
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Not enough patients meeting criteria to enroll in the time period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BerylliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maier, Lisa, M.D.
- Collaborators
- Centocor, Inc., National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Lisa A Maier, MD,MSPH, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111917
- Sponsor's protocol ID
- NJ202
- Other IDs
- 1UL1RR025780
- Acronym
- BISCIT
- Status last verified
- Mar 2016
- First submitted
- 26 May 2005
- Last updated
- 2 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Maier LA, Barkes BQ, Mroz M, Rossman MD, Barnard J, Gillespie M, Martin A, Mack DG, Silveira L, Sawyer RT, Newman LS, Fontenot AP. Infliximab therapy modulates an antigen-specific immune response in chronic beryllium disease. Respir Med. 2012 Dec;106(12):1810-3. doi: 10.1016/j.rmed.2012.08.014. Epub 2012 Sep 11. No abstract available.
PubMed 22974830
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Remicade in Chronic Beryllium Disease: A Randomized, Double-Blind, Placebo-Controlled, Investigator Initiated Trial
- ClinicalTrials.gov ID
- NCT00111917
- Acronym / sponsor ID
- BISCIT / NJ202
- Conditions
- Berylliosis, Beryllium Disease
- Keywords
- Chronic Beryllium Disease, Berylliosis, Beryllium Disease, CBD, Infliximab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough patients meeting criteria to enroll in the time period
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Maier, Lisa, M.D.
- Collaborators
- Centocor, Inc., National Center for Research Resources (NCRR)
- Study start
- Feb 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 27 May 2005 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to test the clinical effectiveness of a drug called infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the lung. Receiving infliximab may help with symptoms, and may improve clinical testing data normally ordered by your doctor, such as breathing tests. Baseline and follow-up testing will look for improvements in breathing tests (pulmonary function testing), exchange of oxygen in the lungs (exercise test), chest x ray, and lung inflammation.
Detailed description
Hypothesis:
The central hypothesis of this study is that infliximab will prove to be efficacious in the treatment of chronic beryllium disease (CBD), and that it will do so by inhibiting beryllium specific T cell proliferation and cytokine production.
Specific Aims:
Specific Aim 1: To determine the clinical effectiveness of infliximab on chronic beryllium disease. The efficacy of infliximab will be measured by improvement in arterial gas exchange, or arterial alveolar oxygen gradient (A-ad02) at end exercise in subjects with CBD who remain symptomatic and with pulmonary impairment despite current treatment with prednisone and/or methotrexate. Secondary outcome measures will include change in airflow, lung volume, diffusing capacity (DLCO), profusion of small opacities on chest x-ray, dyspnea score, and quality of life questionnaires.
Specific Aim 2: To determine the effect of infliximab on intermediate markers of biological function in CBD. In vitro studies will examine the effect of infliximab on blood and lung cells in culture, as measured by a decrease in beryllium (Be)-stimulated lymphocyte proliferation; a decrease in Be-stimulated cytokine production, including TNF-a, IFN-g, and IL-2; altered Be-stimulated apoptosis of macrophages or lymphocytes.
Research Design and Methods: Since no information is available regarding the pharmacokinetics of infliximab in patients with CBD, the pharmacokinetic information available from the use of infliximab in other similar inflammatory conditions formed the basis for selecting the dose regimen for this protocol. Particularly, a 5mg/kg dose will be used for this study, based on the dose selection used in the sarcoidosis protocol C0168T48 presently underway in a multi-center trial (NJC IRB HS-1771).
This is an investigator initiated, 40 week, randomized, double-blind, placebo controlled study to evaluate the efficacy of infliximab dosed at 5mg/kg, compared to placebo, in individuals with symptomatic CBD with pulmonary involvement despite prednisone and/or methotrexate treatment. Infliximab or placebo will be infused at weeks 0, 2, 6, 12, 18, and 24 including spirometry, lung volumes and DLCO. Approximately 20 participants will be enrolled in the study at National Jewish Medical and Research Center at a 3:1 drug: placebo rate.
The primary endpoint of this study will be a change from baseline testing to week 28 testing in the A-adO2 at end exercise on a 6 minute walk. At baseline evaluation, subjects will undergo full pulmonary function testing, a blood draw for the beryllium lymphocyte proliferation test (BeLPT), 6 minute walk, chest x-ray, and quality of life and dyspnea questionnaires. Follow-up full pulmonary function testing, rest and end exercise A-ad02, pulse oximetry with total distance (workload) achieved on a 6 minute walk, and chest radiograph will be measured at week 12. Final outcome measurements (same as baseline testing), including bronchoscopy with BAL, will be repeated at week 28. A follow-up appointment will be scheduled at week 40 to assess patients' general health, as well as measure rest and end exercise A-ad02 and pulse oximetry with 6 minute walk, pulmonary function test, QOL/dyspnea scoring, and chest radiograph interstitial lung opacity profusion score.
The effects of infliximab on the Be-stimulated immune response will be assessed by comparing the following markers before and after infliximab therapy: 1. BeLPT from blood and lavage cells (BAL); 2. Be-stimulated cytokine production from BAL cells including TNF-a, IFN-γ, and IL-2; 3. Cell-specific apoptosis. The assay will include an unstimulated control, 100 mM BeSO4, 100 mM Al2(SO4)3 metal-salt control, PHA - lymphocyte proliferation control, infliximab control, infliximab + BeSO4, infliximab + Al2(SO4)3. At days 4, 5, and 6 after Be exposure, the wells are pulsed with the DNA-specific precursor, 3H-TdR, incubated for four hours, harvested on glass fiber filters, and liquid scintillation methods are used for counting. Results are reported as a stimulation index, which is a ratio of the counts per minute of the treatment group to the counts per minute of the unstimulated group. To determine the effect of infliximab on cytokine production, CBD BAL and CBD PBMC will be stimulated with Be for 24 hours. ELISA will be used to determine TNF-α, IFN-γ, and IL-2 supernatant levels. After 24 hours of beryllium exposure, we will harvest supernatants and perform ELISA testing for TNF-α, IFN-γ, and IL-2. In order to determine if infliximab causes an increase in lymphocyte or macrophage apoptosis, CBD BAL cells will be cultured for 24 hours with Be. Cells will be double stained for CD4+ (Th1) and CD71+ macrophages versus intracellular activated caspase-3, caspase-8 and caspase-9. These in vitro studies will be used to assess the potential biologic function of infliximab on immune mediated diseases using a disease model with known antigen, CBD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infliximab | Experimental | Drug: Infliximabinfusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks. |
| Placebo | Placebo comparator | Other: Placeboinfusion: 3:1 infliximab:placebo ratio administered at 0, 2, 6, 12, 18 and 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 18-80.
- Noncaseating granulomas and/or mononuclear cell infiltrates demonstrated on transbronchial lung biopsy.
- Abnormal blood and/or BAL BeLPT results.
- Current treatment with prednisone and/or methotrexate specifically for CBD and not any other condition, at any range of dosage, for at least 6 months prior to enrollment, and on a stable dosage for at least 1 month prior to first infusion.
- Moderate CBD severity, such that participants can safely undergo bronchoscopy with BAL including PaO2 >= 50 mmHg on room air (at Denver altitude of 5,280 ft).
Key exclusion criteria (27 listed)
- Positive tuberculosis (TB) skin test upon screening: An intradermal tuberculin skin test must be performed within 1 month prior to the first administration of study agent.
- Any evidence of TB.
- Considered ineligible according to the TB eligibility assessment, screening, and early detection of reactivation rules.
- Positive pregnancy test.
- Women who are pregnant, nursing, or planning pregnancy within one year after screening
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 |
|---|---|---|
| InfliximabAlso: Remicadeanti-TNF | Drug | Infliximab |
| PlaceboPlacebo infusion | Other | Placebo |
Primary outcome
A-a Gradient at End Exercise
Time frame: after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen
change in end-exercise A-a gradient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22974830Maier LA, Barkes BQ, Mroz M, Rossman MD, Barnard J, Gillespie M, Martin A, Mack DG, Silveira L, Sawyer RT, Newman LS, Fontenot AP. Infliximab therapy modulates an antigen-specific immune response in chronic beryllium disease. Respir Med. 2012 Dec;106(12):1810-3. doi: 10.1016/j.rmed.2012.08.014. Epub 2012 Sep 11. No abstract available.
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.
Lisa A Maier, MD,MSPH principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Infliximab in people with Berylliosis and Beryllium Disease, run by Maier, Lisa, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 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: stopped early, as of the sponsor's last update on 2 Jun 2016. 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2014). 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?
A-a Gradient at End Exercise (time frame: after 28 week follow-up. The Alveolar-arterial gradient (A-a gradient), is a measure of the difference between the alveolar partial pressure (A) of oxygen and the arterial (a) partial pressure of oxygen). 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 NCT00111917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2016.