Transplant Associated Microangiopathy TAMPhase 2NCT02763644
Efficacy and Safety of LFG316 in Transplant Associated Microangiopathy (TAM) Patients
A Phase 2 study testing LFG316 active drug in people with Transplant Associated Microangiopathy TAM, run by Novartis Pharmaceuticals at 6 sites in 3 countries.
Trial summary
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) . Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant Associated Microangiopathy TAM
- What is being tested?
- LFG316 active drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 22 Apr 2016to 30 Jun 2017
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent/assent before any study-specific screening procedures. For pediatric patients, consent will be obtained from parent(s) or legal guardian(s) and the signature of at least 1 parent or guardian will be required. Investigators will also obtain assent of patients according to local, regional or national guidelines.
- Patients after allogeneic stem cell transplantation from a related or unrelated, HLA-matched or mismatched donor with the diagnosis of transplant related microangiopathy. Patients having received any of the following stem cell sources are eligible: G-CSF mobilized peripheral blood stem cells, bone marrow, umbilical cord blood.
- Male and female TAM patients ≥ 2 years old at the time of first dose administration. Patients < 12 years old can only be included in the study after first IA has shown that it is safe and well tolerated in patients ≥ 12 years old (Section 3.5).
- The presence of TAM as per below diagnostic criteria at baseline (or screening if baseline visit is skipped). All the criteria have to be met for the patients included in the study:
- Elevated lactate dehydrogenase (any elevation above normal range)
- Thrombocytopenia with platelet count < 50x10e9/L or more than 50% decrease in platelet count from the highest value achieved after transplant
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- Anemia below lower limit of normal or anemia requiring transfusion support as per center standard
- Schistocytes on peripheral blood smear (>2 per HPF) OR histologic evidence of microangiopathy
- Absence of coagulopathy (no uncompensated disseminated intravascular coagulation, DIC) at screening
- The presence of TAM high risk features at baseline (or screening if baseline visit is skipped): Patients ≤ 16 years must have a Lansky score of ≤ 70 and patients > 16 must have Karnofsky score ≤ 70% and/or proteinuria (> 30 mg/dL) measured in two urine spot analyses.
- Hypertension, defined for adults by SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg at baseline (or screening if baseline visit is skipped), and for pediatric patients by blood pressure greater than the 95th percentile for age, sex, and height (see Table 16-1). Additionally, patients who were started on antihypertensive medication after HSCT or who have received additional antihypertensive medication after HSCT will be eligible, even if they don't have elevated blood pressure.
- Able to receive antibiotic prophylaxis against N. meningitides for the duration of the study.
- Meningococcal vaccine(s) prior to LFG316 treatment if prior vaccination cannot be confirmed. The choice of vaccine(s) should take into account the serotypes prevalent in the geographic areas in which study patients will be enrolled. In case vaccination is not possible or will result in an unfavorable risk benefit ratio as judged by the investigator, vaccination can be postponed until deemed likely to be effective.
- Patients <18 years old should receive vaccination for the prevention of S. pneumoniae and H. influenzae type b prior to LFG316 administration. In case vaccination is not possible or will result in an unfavorable risk benefit ratio as judged by the investigator, vaccination can be postponed until deemed likely to be effective.
- Weight of at least 10kg.
Who cannot join
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or even longer if required by local regulations. Concomitant investigational treatment, including treatment in the context of a clinical trial with marketed drugs (off-label) may be acceptable but requires approval by the sponsor on the case by case basis.
- Known hypersensitivity to any constituent of the study medication.
- Patients with steroid refractory graft versus host disease (SRGvHD). SRGvHD is defined as progression (=increase in overall grade) after 5 days on ≥2mg/kg methylprednisolone or equivalent OR no improvement (no decrease in overall grade) after 10 days on ≥ 2mg/kg methylprednisolone or equivalent. If patients are receiving steroids for GvHD prophylaxis as per center standard, progression after 5 days and no response after 10 days after doubling the steroid dose will be regarded as steroid refractory.
- Patients with ALT > 10x ULN at screening.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (at screening or baseline).
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 45 days after stopping study medication. Highly effective contraception methods include:
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- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (i.e., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
- Female sterilization (have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
- Male sterilization (at least 6 m prior to screening). The vasectomized male partner should be the sole partner for that subject.
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception.
- In case of use of oral contraception women should have been stabile on the same pill for a minimum of 3 months before taking study treatment.
- Sexually active males unwilling to use a condom during intercourse while taking drug and for 45 days after stopping investigational medication. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Male patients should not father a child in this period.
- Positive HIV (ELISA and Western blot) test result (checked at screening). Historical local data will be acceptable if it the test was done within one month before start of HSCT conditioning and not more than 3 months before study visit 3.
- A positive Hepatitis B surface antigen or Hepatitis C test result at screening. Historical local data will be acceptable if it the test was done within one month before start of HSCT conditioning and not more than 3 months before study visit 3.
- Patients with any severe, progressive or uncontrolled acute or chronic medical condition (such as uncontrolled infectious disease or sepsis) or clinical laboratory abnormalities that in the investigator's opinion would make the patient inappropriate for entry into this study (at screening or baseline).
- Patients with proven TTP as per historical data (as defined by ADAMST13 activity test) and if already available results of ADAMST13 test done at screening.
- Patients previously treated with eculizumab for TAM.
- Patients with known or suspected hereditary complement pathway deficiency. This exclusion criterion is not applicable to patients with complement pathway abnormalities/upregulation known to be associated with increased risk of transplant associated microangiopathy
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States2 sites
Novartis Investigative Site
Chapel Hill, North Carolina, 27599
Novartis Investigative Site
Columbus, Ohio, 43210
France2 sites
Novartis Investigative Site
Marseille, 13273
Novartis Investigative Site
Paris, Cedex 10, 75475
Germany2 sites
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Heidelberg, 69120
About this study
Official title: A Randomized, Open Label, Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFG316 in Patients With Transplant Associated Microangiopathy After Hematopoietic Precursor Cell Transplantation
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) .
Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed
Read the detailed description
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT). Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks, 36 weeks follow up, and end of study visit (EOS) at week 52. Duration of follow up depended on duration of treatment. Patients who are treated for more than 41 weeks will proceed directly to EOS visit.
Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers.
Patients showing worsening of disease after two weeks of treatment or showing no response at week 4 or any time after will be considered failures and can be switched to receive the alternative treatment (SoC or LFG316). Patients can only switch treatment arms once.
- Being tested
- LFG316 active drug, Standard of care treatment
- Keywords
- transplant associated microangiopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFG316 active drugDrug
Also called LFG316
LFG316
Standard of care treatmentOther
Also called SoC
SoC (site specific)
| Study group | Role | What they receive |
|---|---|---|
| LFG316 plus SoC | Experimental | LFG316 plus SoC (excluding plasmapheresis and prohibited treatment) Receives: Drug: LFG316 active drug; Other: Standard of care treatment |
| All SoC first | Experimental | Standard of Care then LFG316 plus SoC Receives: Drug: LFG316 active drug; Other: Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks
Hematological response rate was to be assessed at 17 weeks. However, due to early termination and with too few patients for statistical inference, the comparison between the two treatment arms LFG316 and SoC was not performed, and only descriptive statistics at different visits are provided for schistocytes Schistocytes <2/microscopic high power field (HPF) showed a hematological response
Measured: 17 weeks
Secondary outcomes (5)
Peak Plasma Concentration (Cmax)
Peak plasma concentration (Cmax) Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1 and not at 52 Weeks
Measured: Day 1
Area Under the Plasma Concentration Versus Time Curve (AUC Last)
Area under the plasma concentration versus time curve (AUC last) AUC up to the last measurable concentration. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1
Measured: Day 1
Time to Reach the Maximal Concentration (Tmax)
Time to reach the maximal concentration (Tmax)Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference therefore only summary statistics of serum PK values at Day 1
Measured: Day 1
Complete Response Rate at 17 Weeks
Complete response rate was planned to be assessed at 17 weeks. However, due to early termination and low sample size the comparison between the two treatment arms LFG316 and SoC was not performed. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.
Measured: 17 weeks
Non-relapse Mortality
Time to non-relapse-related mortality up to 17 weeks was not assessed due to the paucity of data. Only seven adult patients were enrolled prior to the early study termination decision. Due to low confidence of clinical benefit, this study was closed. There was too few patients for statistical inference.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study start22 Apr 2016
- Primary completion10 Feb 2017
- Study completion30 Jun 2017
Why it stopped: LFG316, had been studied in seven patients with transplantation-associated microangiopathy. Due to low confidence of clinical benefit, this study was closed.
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 Transplant Associated Microangiopathy TAMStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christoph Bucher, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763644
- Sponsor's protocol ID
- CLFG316X2202
- Status last verified
- Mar 2019
- First submitted
- 14 Apr 2016
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Controlled, Multiple Dose Study to Evaluate the Clinical Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LFG316 in Patients With Transplant Associated Microangiopathy After Hematopoietic Precursor Cell Transplantation
- ClinicalTrials.gov ID
- NCT02763644
- Acronym / sponsor ID
- CLFG316X2202
- Keywords
- transplant associated microangiopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: LFG316, had been studied in seven patients with transplantation-associated microangiopathy. Due to low confidence of clinical benefit, this study was closed.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2016 (actual)
- Primary completion
- 10 Feb 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 May 2016 (estimated)
- Results
- Posted 17 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT) .
Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks.Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers. This trial was terminated: LFG316, a monoclonal antibody inhibitor of complement factor 5 (C5), had been studied in seven patients with transplantation-associated microangiopathy (TAM). Due to low confidence of clinical benefit, this study was closed
Detailed description
This was a randomized, SoC-controlled, open-label, multi-center study in patients with TAM after hematopoietic precursor cell transplantation (HPCT). Study consisted of up to 28 days of screening period, 16 weeks treatment period that can be extended to 45 weeks, 36 weeks follow up, and end of study visit (EOS) at week 52. Duration of follow up depended on duration of treatment. Patients who are treated for more than 41 weeks will proceed directly to EOS visit.
Approximately 40 patients was to be randomized to receive SoC or LFG316 plus SoC. Patients was included in the study if they have diagnosis of TAM and poor prognostic markers.
Patients showing worsening of disease after two weeks of treatment or showing no response at week 4 or any time after will be considered failures and can be switched to receive the alternative treatment (SoC or LFG316). Patients can only switch treatment arms once.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LFG316 plus SoC | Experimental | Drug: LFG316 active drug, Other: Standard of care treatmentLFG316 plus SoC (excluding plasmapheresis and prohibited treatment) |
| All SoC first | Experimental | Drug: LFG316 active drug, Other: Standard of care treatmentStandard of Care then LFG316 plus SoC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Written informed consent/assent before any study-specific screening procedures. For pediatric patients, consent will be obtained from parent(s) or legal guardian(s) and the signature of at least 1 parent or guardian will be required. Investigators will also obtain assent of patients according to local, regional or national guidelines.
- Patients after allogeneic stem cell transplantation from a related or unrelated, HLA-matched or mismatched donor with the diagnosis of transplant related microangiopathy. Patients having received any of the following stem cell sources are eligible: G-CSF mobilized peripheral blood stem cells, bone marrow, umbilical cord blood.
- Male and female TAM patients ≥ 2 years old at the time of first dose administration. Patients < 12 years old can only be included in the study after first IA has shown that it is safe and well tolerated in patients ≥ 12 years old (Section 3.5).
- The presence of TAM as per below diagnostic criteria at baseline (or screening if baseline visit is skipped). All the criteria have to be met for the patients included in the study:
- The presence of TAM high risk features at baseline (or screening if baseline visit is skipped): Patients ≤ 16 years must have a Lansky score of ≤ 70 and patients > 16 must have Karnofsky score ≤ 70% and/or proteinuria (> 30 mg/dL) measured in two urine spot analyses.
Key exclusion criteria (18 listed)
- Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or until the expected PD effect has returned to baseline, whichever is longer; or even longer if required by local regulations. Concomitant investigational treatment, including treatment in the context of a clinical trial with marketed drugs (off-label) may be acceptable but requires approval by the sponsor on the case by case basis.
- Known hypersensitivity to any constituent of the study medication.
- Patients with steroid refractory graft versus host disease (SRGvHD). SRGvHD is defined as progression (=increase in overall grade) after 5 days on ≥2mg/kg methylprednisolone or equivalent OR no improvement (no decrease in overall grade) after 10 days on ≥ 2mg/kg methylprednisolone or equivalent. If patients are receiving steroids for GvHD prophylaxis as per center standard, progression after 5 days and no response after 10 days after doubling the steroid dose will be regarded as steroid refractory.
- Patients with ALT > 10x ULN at screening.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (at screening or baseline).
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 |
|---|---|---|
| LFG316 active drugAlso: LFG316LFG316 | Drug | All SoC first, LFG316 plus SoC |
| Standard of care treatmentAlso: SoCSoC (site specific) | Other | All SoC first, LFG316 plus SoC |
Primary outcome
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks
Time frame: 17 weeks
Hematological response rate was to be assessed at 17 weeks. However, due to early termination and with too few patients for statistical inference, the comparison between the two treatment arms LFG316 and SoC was not performed, and only descriptive statistics at different visits are provided for schistocytes Schistocytes <2/microscopic high power field (HPF) showed a hematological response
5 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Day 1
Area Under the Plasma Concentration Versus Time Curve (AUC Last)
Time frame: Day 1
Time to Reach the Maximal Concentration (Tmax)
Time frame: Day 1
Complete Response Rate at 17 Weeks
Time frame: 17 weeks
Non-relapse Mortality
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Related trials for Transplant Associated Microangiopathy TAM
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
RecruitingObservational study
Cell Free DNA Profiling As a Tool to Monitor Clinically-Relevant Events in Allogeneic Hematopoietic Stem Cell Transplantation
GVHD - Graft-Versus-Host Disease, Infections After HSCT
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.
Christoph Bucher study director
Novartis Pharmaceuticals
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LFG316 active drug in people with Transplant Associated Microangiopathy TAM, run by Novartis Pharmaceuticals at 6 sites in 3 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 15 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, France, Germany. 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 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 17 Apr 2019). 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?
Number of Schistocytes Per 1,000 Red Blood Cells (RBCs) for Hematological Responder Rate at 17 Weeks (time frame: 17 weeks). 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 5 Jan 2021.