Chronic Lymphocytic LeukemiaPhase 1/2NCT01397149
Eltrombopag in Thrombocytopenic Chronic Lymphocytic Leukemia (CLL) Patients (CLL2S Study of GCLLSG)
A Phase 1/2 study testing Eltrombopag in people with Chronic Lymphocytic Leukemia and Thrombocytopenia, run by University of Ulm at 10 sites in 2 countries.
Trial summary
The aim of this study is to find the appropriate dose of eltrombopag in thrombocytopenic CLL patients, that shortens the duration of the thrombocytopenia and achieves platelet count of ≥ 100/nl prior to the start of chemotherapy containing alkylating agents and/or Purine Analogues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia, Thrombocytopenia
- What is being tested?
- Eltrombopag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Oct 2011to Nov 2014
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CLL (based immunophenotyping performed at the central reference laboratory of the GCLLSG in Cologne)
- Platelet count <50 000/μl at time of screening (measured and confirmed twice)
- Patient is planned to receive alkylating agents and/or fludarabine-based therapy as 2nd or higher-line treatment
- ECOG Performance Status of 0-2
- Age >= 18 years
- Signed written informed consent, according to ICH-GCP, and national/local regulation, prior to performing any study-specific procedures
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- Negative pregnancy test and willingness to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- Able to understand and comply with protocol requirements and instructions and intend to complete the study as planned.
- Adequate renal function (creatinine must not exceed the upper limit of normal (ULN) reference range by more than 50%) at study entry
- Adequate liver function: bilirubin £ 1.5 times the upper limit of normal. ALT or AST <= 3 times the upper limit of normal without liver involvement with CLL and <= 5 times the upper limit of normal in case of the liver involvement with CLL
- Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must be within 80 to 120% of the normal range with no history of hypercoagulable state
- Total albumin must not be below the lower limit of normal (LLN) by more than 20%.
Who cannot join
- Thrombocytopenia that is primarily caused by ITP
- Refractory CLL: defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of last fludarabine and/or bendamustine based therapy. NOTE: Subjects refractory to rituximab monotherapy as last therapy are permitted
- No prior therapy for CLL
- Active autoimmune hemolytic anemia (AIHA) requiring corticosteroid therapy >100mg equivalent to hydrocortisone, or chemotherapy
- Platelet count > 50 000/μl at screening
- Richter's transformation
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- CNS involvement of B-CLL
- Active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
- Past or current malignancy other than CLL (with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix or breast) unless tumor was successfully treated with curative intent at least 2 years prior to trial entry
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months, congestive heart failure, etc.
- History of significant cerebrovascular disease
- Recurring venous thrombosis or pulmonary embolism
- Glucocorticoids unless given in doses <= 100 mg/day hydrocortisone (or equivalent dose of other glucocorticoids) and for exacerbations other than CLL (e.g. asthma)
- Known HIV positivity
- Active hepatitis B, C
- Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of eltrombopag.
- Subjects known or suspected of not being able to comply with a study protocol
- Patients with recent history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within the preceding 6 months. Patients with recurrent arterial or venous thromboembolic events.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Germany9 sites
Universitätsklinikum Köln; Klinik I für Innere Medizin
Cologne, 50924
Universitätsklinikum Carl Gustav Carus Med. Klinik und Poliklinik I
Dresden, 01307
Gemeinschaftspraxis für Innere Medizin, Hämatologie und Internistische Onkologie
Erlangen, 91052
Universitätsklinikum; Klinik für Hämatologie
Essen, 45147
Klinikum Frankfurt (Oder) Medizinische Klinik I
Frankfurt (Oder), 15236
Universitätsklinikum Schleswig-Holstein, II. Medizinische Klinik und Poliklinik im Städtischen Krankenhaus
Kiel, 24116
Onkologische Schwerpunktpraxis Leer-Emden
Leer, 26789
Städtisches Klinikum München GmbH, Klinikum Schwabing, Klinik für Hämatologie, Immunologie, Palliativmedizin, Infektiologie und Tropenmedizin
München, 80804
Universitätsklinikum Ulm, Medizinische Klinik III
Ulm, 89081
Austria1 site
Medizinische Universität Wien, Innere Medizin I, Abt. Hämatologie und Hämastaseologie
Vienna, 1090
About this study
Official title: A Phase I/II, Multi-centre Trial to Assess the Safety, Efficacy, and Pharmacokinetics of Eltrombopag, Administered to Thrombocytopenic Chronic Lymphocytic Leukemia Patients Prior to Alkylating Agents and/or Purine Analogue-based Therapy
The aim of this study is to find the appropriate dose of eltrombopag in thrombocytopenic CLL patients, that shortens the duration of the thrombocytopenia and achieves platelet count of ≥ 100/nl prior to the start of chemotherapy containing alkylating agents and/or Purine Analogues.
Read the detailed description
The study is divided in a Phase I and a Phase II part. The phase I part uses an open-label, dose escalation design in order to find the appropriate, feasible dose of eltrombopag to achieve a durable increase in platelet count.
In phase II, patients will be randomized (2:1 eltrombopag : placebo) to explore the efficacy and confirm the safety of the identified eltrombopag dose from Phase I. Eltrombopag/placebo will be administered before starting each cycle and will continue during all cycles of treatment until subjects finish treatment with chemotherapy. The schedule and days of eltrombopag dosing in Phase II will be determined based on data analyzed from Phase I, but will not exceed the defined maximum tolerable dose (MTD).
Severe thrombocytopenia is a frequently associated hematologic condition in patients with CLL. In the earlier stages of the disease, mild thrombocytopenia is common in approximately 25% of CLL patients. Later in the disease, the bone marrow will become more extensively infiltrated by the neoplastic cells, which results in more severe thrombocytopenia. Thrombocytopenia in patients with CLL could result from the disease, a packed marrow or from autoimmunity/ITP. For patients with CLL who develop severe thrombocytopenia, treatment options are limited and administration of platelet transfusions is common. Additionally, treatment of CLL patients with chemotherapy to treat the disease can be hampered due to severe thrombocytopenia. The clinical consequences of severe thrombocytopenia include an increased tendency for bleeding, probably due to thrombocytopenia, compromised hemostasis, and delayed administration of chemotherapy with the consequence of less optimal disease control.
Eltrombopag is an orally bioavailable small molecule TPO receptor (TPO-R) agonist being developed by GlaxoSmithKline (GSK) as a treatment for thrombocytopenia. Eltrombopag has been shown to stimulate platelet production and elevates platelet counts in healthy volunteers and in patients with chronic ITP, and in patients with thrombocytopenia related to hepatitis C virus (HCV) (Jenkins, Blood 2007; Bussel, NEJM 2007; McHutchinson NEJM 2007).
The optimal dose of eltrombopag for thrombocytopenic patients with CLL is currently unknown. As such, one objective of this study is to define a safe and effective dose of eltrombopag for thrombocytopenic patients with CLL prior to alkylating agent and/or fludarabine-based therapy. The eltrombopag doses proposed for administration in this study are 75 mg up to 300 mg once daily.
As a prerequisite for the trial, detailed studies have been performed in laboratory of the principal investigator on the in-vitro effects of eltrombopag on CLL cells regarding cell survival, differentiation and proliferation. The results suggest that eltrombopag is unlikely to act as a growth factor in CLL. Therefore clinical trials investigating its effect on platelet counts in CLL are warranted (Zenz T. et al., ASH 2009).
- Conditions
- Chronic Lymphocytic Leukemia, Thrombocytopenia
- Being tested
- Placebo, Eltrombopag
- Keywords
- Chronic lymphocytic leukemia, Thrombocytopenia, Alkylating agents, Purine derivatives, TPO receptor agonist
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Dosage form, frequency and duration exactly as experimental arm.
EltrombopagDrug
Also called Revolade, Promacta
Phase I:
Single arm dose-escalation trial part, to test 4 doses of eltrombopag (75mg, 150mg, 225mg, 300mg) to find the appropriate, feasible dose to achieve a durable increase in platelet count (≥100,000/µl). Eltrombopag will be administered once daily at the respective dose level for 2 weeks (unless platelet counts rise to > 400,000/µl).
Phase II:
Patients will be randomized (2:1 eltrombopag : placebo) to explore the efficacy and confirm the safety of the identified dose level from Phase I. Eltrombopag/placebo will be administered before starting each cycle (and possibly following chemotherapy treatment depending on data from phase I), and will continue during all cycles of treatment until subjects finish chemotherapy (alkylating agents and/or purine analogue-based therapy). The schedule and days of eltrombopag dosing in Phase II will be determined based on data analyzed from Phase I.
| Study group | Role | What they receive |
|---|---|---|
| Eltrombopag | Experimental | In phase II, patients will be randomized (2:1 eltrombopag : placebo) to receive either eltrombopag or placebo to explore the efficacy and confirm the safety of the identified eltrombopag dose from Phase I. Receives: Drug: Eltrombopag |
| Film coated tablet | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in platelet count
Time points of assessment:
1 wk before treatment; 2-3 times/wk during treatment; 30d after end of treatment
Treatment duration:
- Phase I: Two weeks
- Phase II: Eltrombopag is given as concomitant treatment to chemotherapy, with a max. duration of max. 6 cycles of 28 days each. The exact schedule of Eltrombopag administration will be determined after evaluation of Phase I results.
Measured: up to 7 months
Secondary outcomes (9)
Adverse events
Time points of assessment: 1 wk before and continously during treatment up to day 60 after last eltrombopag/placebo administration.
Treatment duration: see primary outcome measure.
Measured: up to 8 months
Change in vital signs
Time points of assessment: 1 wk before treatment; at start of each chemotherapy cycle (Phase II); up to day 30 after last eltrombopag/placebo administration. Treatment duration: see primary outcome measure.
Measured: up to 7 months
Change in clinical laboratory parameters
Time points of assessment: 1 wk before treatment; at start of each chemotherapy cycle (Phase II); up to day 30 after last eltrombopag/placebo administration. Treatment duration: see primary outcome measure.
Measured: up to 7 months
Bleeding events
Time points of assessment: 1 wk before treatment; at start of each chemotherapy cycle (Phase II); up to day 30 after last eltrombopag/placebo administration.
Assessed by WHO bleeding scale. Treatment duration: see primary outcome measure.
Measured: up to 7 months
Number of required platelet transfusions
Time points of assessment: 1 wk before treatment; at start of each chemotherapy cycle (Phase II); up to day 30 after last eltrombopag/placebo administration Treatment duration: see primary outcome measure.
Measured: up to 7 months
Number of chemotherapy dose delay/dose reduction
Time points of assessment: 1 wk before treatment; at start of each chemotherapy cycle (Phase II); up to day 30 after last eltrombopag/placebo administration. In phase II only.
Measured: up to 7 months
CLL overall response rate
Time points of assessment: at start of each chemotherapy cycle (Phase II); up to day 30 after last eltrombopag/placebo administration. In phase II only.
Measured: up to 7 months
Time to CLL progression
In phase II only.
Pre-defined subgroups based on the following stratification factors:
- prior lines of treatment (1 vs. 2 vs. 3)
- platelet count at baseline ≤ 30,000/µL vs > 30,000
Measured: up to 2 years
Trough-level pharmacokinetics of eltrombopag
Assessment at day 1 of each week with eltrombopag administration.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2013
- Study completionNov 2014
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, German CLL Study Group, WiSP Wissenschaftlicher Service Pharma GmbH
- Responsible party
- Principal investigator, Stephan Stilgenbauer, University of Ulm
- Investigators
- Stephan Stilgenbauer, Prof. Dr., Principal investigator, Universitätsklinikum Ulm, Medizinische Klinik III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397149
- Sponsor's protocol ID
- CLL2S
- Other IDs
- 2010-023022-20
- Status last verified
- May 2015
- First submitted
- 30 Jun 2011
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multi-centre Trial to Assess the Safety, Efficacy, and Pharmacokinetics of Eltrombopag, Administered to Thrombocytopenic Chronic Lymphocytic Leukemia Patients Prior to Alkylating Agents and/or Purine Analogue-based Therapy
- ClinicalTrials.gov ID
- NCT01397149
- Acronym / sponsor ID
- CLL2S
- Conditions
- Chronic Lymphocytic Leukemia, Thrombocytopenia
- Keywords
- Chronic lymphocytic leukemia, Thrombocytopenia, Alkylating agents, Purine derivatives, TPO receptor agonist
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, German CLL Study Group, WiSP Wissenschaftlicher Service Pharma GmbH
- Study start
- Oct 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 19 Jul 2011 (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.
The aim of this study is to find the appropriate dose of eltrombopag in thrombocytopenic CLL patients, that shortens the duration of the thrombocytopenia and achieves platelet count of ≥ 100/nl prior to the start of chemotherapy containing alkylating agents and/or Purine Analogues.
Detailed description
The study is divided in a Phase I and a Phase II part. The phase I part uses an open-label, dose escalation design in order to find the appropriate, feasible dose of eltrombopag to achieve a durable increase in platelet count.
In phase II, patients will be randomized (2:1 eltrombopag : placebo) to explore the efficacy and confirm the safety of the identified eltrombopag dose from Phase I. Eltrombopag/placebo will be administered before starting each cycle and will continue during all cycles of treatment until subjects finish treatment with chemotherapy. The schedule and days of eltrombopag dosing in Phase II will be determined based on data analyzed from Phase I, but will not exceed the defined maximum tolerable dose (MTD).
Severe thrombocytopenia is a frequently associated hematologic condition in patients with CLL. In the earlier stages of the disease, mild thrombocytopenia is common in approximately 25% of CLL patients. Later in the disease, the bone marrow will become more extensively infiltrated by the neoplastic cells, which results in more severe thrombocytopenia. Thrombocytopenia in patients with CLL could result from the disease, a packed marrow or from autoimmunity/ITP. For patients with CLL who develop severe thrombocytopenia, treatment options are limited and administration of platelet transfusions is common. Additionally, treatment of CLL patients with chemotherapy to treat the disease can be hampered due to severe thrombocytopenia. The clinical consequences of severe thrombocytopenia include an increased tendency for bleeding, probably due to thrombocytopenia, compromised hemostasis, and delayed administration of chemotherapy with the consequence of less optimal disease control.
Eltrombopag is an orally bioavailable small molecule TPO receptor (TPO-R) agonist being developed by GlaxoSmithKline (GSK) as a treatment for thrombocytopenia. Eltrombopag has been shown to stimulate platelet production and elevates platelet counts in healthy volunteers and in patients with chronic ITP, and in patients with thrombocytopenia related to hepatitis C virus (HCV) (Jenkins, Blood 2007; Bussel, NEJM 2007; McHutchinson NEJM 2007).
The optimal dose of eltrombopag for thrombocytopenic patients with CLL is currently unknown. As such, one objective of this study is to define a safe and effective dose of eltrombopag for thrombocytopenic patients with CLL prior to alkylating agent and/or fludarabine-based therapy. The eltrombopag doses proposed for administration in this study are 75 mg up to 300 mg once daily.
As a prerequisite for the trial, detailed studies have been performed in laboratory of the principal investigator on the in-vitro effects of eltrombopag on CLL cells regarding cell survival, differentiation and proliferation. The results suggest that eltrombopag is unlikely to act as a growth factor in CLL. Therefore clinical trials investigating its effect on platelet counts in CLL are warranted (Zenz T. et al., ASH 2009).
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 |
|---|---|---|
| Eltrombopag | Experimental | Drug: EltrombopagIn phase II, patients will be randomized (2:1 eltrombopag : placebo) to receive either eltrombopag or placebo to explore the efficacy and confirm the safety of the identified eltrombopag dose from Phase I. |
| Film coated tablet | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed diagnosis of CLL (based immunophenotyping performed at the central reference laboratory of the GCLLSG in Cologne)
- Platelet count <50 000/μl at time of screening (measured and confirmed twice)
- Patient is planned to receive alkylating agents and/or fludarabine-based therapy as 2nd or higher-line treatment
- ECOG Performance Status of 0-2
- Age >= 18 years
Key exclusion criteria (18 listed)
- Thrombocytopenia that is primarily caused by ITP
- Refractory CLL: defined as treatment failure (failure to achieve a CR or PR) or disease progression within 6 months of last fludarabine and/or bendamustine based therapy. NOTE: Subjects refractory to rituximab monotherapy as last therapy are permitted
- No prior therapy for CLL
- Active autoimmune hemolytic anemia (AIHA) requiring corticosteroid therapy >100mg equivalent to hydrocortisone, or chemotherapy
- Platelet count > 50 000/μl at 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 |
|---|---|---|
| PlaceboDosage form, frequency and duration exactly as experimental arm. | Drug | Film coated tablet |
| EltrombopagAlso: Revolade, PromactaPhase I: Single arm dose-escalation trial part, to test 4 doses of eltrombopag (75mg, 150mg, 225mg, 300mg) to find the appropriate, feasible dose to achieve a durable increase in platelet count (≥100,000/µl). Eltrombopag will be administered once daily at the respective dose level for 2 weeks (unless platelet counts rise to > 400,000/µl). Phase II: Patients will be randomized (2:1 eltrombopag : placebo) to explore the efficacy and confirm the safety of the identified dose level from Phase I. Eltrombopag/placebo will be administered before starting each cycle (and possibly following chemotherapy treatment depending on data from phase I), and will continue during all cycles of treatment until subjects finish chemotherapy (alkylating agents and/or purine analogue-based therapy). The schedule and days of eltrombopag dosing in Phase II will be determined based on data analyzed from Phase I. | Drug | Eltrombopag |
Primary outcome
Change in platelet count
Time frame: up to 7 months
Time points of assessment: 1 wk before treatment; 2-3 times/wk during treatment; 30d after end of treatment Treatment duration: * Phase I: Two weeks * Phase II: Eltrombopag is given as concomitant treatment to chemotherapy, with a max. duration of max. 6 cycles of 28 days each. The exact schedule of Eltrombopag administration will be determined after evaluation of Phase I results.
9 secondary outcomes
Adverse events
Time frame: up to 8 months
Change in vital signs
Time frame: up to 7 months
Change in clinical laboratory parameters
Time frame: up to 7 months
Bleeding events
Time frame: up to 7 months
Number of required platelet transfusions
Time frame: up to 7 months
Number of chemotherapy dose delay/dose reduction
Time frame: up to 7 months
CLL overall response rate
Time frame: up to 7 months
Time to CLL progression
Time frame: up to 2 years
Trough-level pharmacokinetics of eltrombopag
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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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.
Stephan Stilgenbauer, Prof. Dr. principal investigator
Universitätsklinikum Ulm, Medizinische Klinik III
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Eltrombopag in people with Chronic Lymphocytic Leukemia and Thrombocytopenia, run by University of Ulm at 10 sites in 2 countries.
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 12 inclusion and 18 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 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria. 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?
The study was stopped early (reason given: Insufficient recruitment). 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?
Change in platelet count (time frame: up to 7 months). 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 May 2015.