PIK3CA-related Overgrowth SpectrumNCT05294289
Health-related Quality of Life, Symptom Severity, and Pain Among Patients With PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study
An observational study of PIK3CA-related Overgrowth Spectrum, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This was a mixed-methods observational study that incorporated both qualitative interviews and longitudinal quantitative data collection through an online survey (initial, 2 months, and 4 months). Read more about this study
- Who is it for?
- Ages 5 to 99 years
- Conditions the study is for
- PIK3CA-related Overgrowth Spectrum
- What is being tested?
- Alpelisib
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 28 Jun 2024
- Phase
- Observational
- 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 5 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Three groups of of participants were included: * Adults with PROS who are capable of independently completing the required Clinical Outcome Assessments (adult self-report) * Adolescents, between the ages of 12 and 17 (inclusive), with PROS who are capable of independently completing the required Clinical Outcome Assessments, as assessed by a legal guardian (adolescent self-report). * Caregivers of children/adolescents with PROS (caregivers proxy-report). these must be parents or legal guardians whose children are between the ages of 5 and 11, or adolescents between the ages of 12 and 17 who are unable to independently complete the required Clinical Outcome Assessments.
Who may be able to join
- Adult patients:
- At least 18 years of age
- Self-reports having been diagnosed with 1 of the following syndromes:
- Klippel-Trenaunay Syndrome (KTS)
- Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, Scoliosis/Skeletal and spinal (CLOVES syndrome)
- Isolated Lymphatic Malformation (ILM)
Show all 56Show fewer
- Megalencephaly-Capillary Malformation (MCAP or M-CM)
- Hemimegalencephaly (HME)/Dysplastic Megalencephaly (DMEG)/Focal cortical dysplasia type II
- Hemihyperplasia-Multiple Lipomatosis (HHML)
- Facial Infiltrating Lipomatosis (FIL)
- Fibroadipose Vascular Anomaly (FAVA)
- Macrodactyly
- Hemihyperplasia (Muscular HH)
- Fibroadipose hyperplasia or Overgrowth (FAO)
- Capillary malformation of the lower lip, Lymphatic malformation of the face and neck, Asymmetry of the face and limbs, and Partial or generalized Overgrowth (CLAPO syndrome)
- Epidermal nevus, benign lichenoid keratosis, or seborrheic keratosis
- Able to converse and read/answer survey questions in English
- Willing and able to provide informed consent
- Adolescent patients
- Between the ages of 12 and 17 years
- Self-reports having been diagnosed with one of the following syndromes:
- Klippel-Trenaunay Syndrome (KTS)
- Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, Scoliosis/Skeletal and spinal (CLOVES syndrome)
- Isolated Lymphatic Malformation (ILM)
- Megalencephaly-Capillary Malformation (MCAP or M-CM)
- Hemimegalencephaly (HME)/Dysplastic Megalencephaly (DMEG)/Focal cortical dysplasia type II
- Hemihyperplasia-Multiple Lipomatosis (HHML)
- Facial Infiltrating Lipomatosis (FIL)
- Fibroadipose Vascular Anomaly (FAVA)
- Macrodactyly
- Hemihyperplasia (Muscular HH)
- Fibroadipose hyperplasia or Overgrowth (FAO)
- Capillary malformation of the lower lip, Lymphatic malformation of the face and neck, Asymmetry of the face and limbs, and Partial or generalized Overgrowth (CLAPO syndrome)
- Epidermal nevus, benign lichenoid keratosis, or seborrheic keratosis
- Able to converse and read/answer survey questions in English independently, as assessed by guardian
- Willing and able to provide assent
- Has a parent/legal guardian who is able and willing to provide permission for the adolescent to participate
- Caregivers
- At least 18 years of age
- Is the parent/legal guardian of a child/adolescent who has been diagnosed with one of the following syndromes:
- Klippel-Trenaunay Syndrome (KTS)
- Congenital Lipomatous Overgrowth, Vascular Malformations, Epidermal Nevi, Scoliosis/Skeletal and spinal (CLOVES syndrome)
- Isolated Lymphatic Malformation (ILM)
- Megalencephaly-Capillary Malformation (MCAP or M-CM)
- Hemimegalencephaly (HME)/Dysplastic Megalencephaly (DMEG)/Focal cortical dysplasia type II
- Hemihyperplasia-Multiple Lipomatosis (HHML)
- Facial Infiltrating Lipomatosis (FIL)
- Fibroadipose Vascular Anomaly (FAVA)
- Macrodactyly
- Hemihyperplasia (Muscular HH)
- Fibroadipose hyperplasia or Overgrowth (FAO)
- Capillary malformation of the lower lip, Lymphatic malformation of the face and neck, Asymmetry of the face and limbs, and Partial or generalized Overgrowth (CLAPO syndrome)
- Epidermal nevus, benign lichenoid keratosis, or seborrheic keratosis
- Child is either between the ages of 5 and 11 (inclusive), or between the ages of 12 and 17 years (inclusive) but is unable to self-report due to cognitive difficulties
- Able to converse and read/answer survey questions in English
- Willing and able to provide informed consent
Who cannot join
- There are no specific exclusion criteria. However, participants may be excluded if the quota related to alpelisib treatment (60 treated with alpelisib; 40 not treated with alpelisib) has been achieved. For example, if 40 participants not treated with alpelisib have been recruited into the study, any additional participants not treated with alpelisib will be excluded. Patients treated with alpelisib may be similarly excluded if the quota of 60 patients has already been achieved.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
Official title: Health-related Quality of Life, Symptom Severity, and Pain Among Patients Treated With Alpelisib for PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study
This was a mixed-methods observational study that incorporated both qualitative interviews and longitudinal quantitative data collection through an online survey (initial, 2 months, and 4 months).
Read the detailed description
This study collected qualitative data through interviews with patients and caregivers and qualitative data through a web-based longitudinal survey.
Both parts of the study were designed to collect information on HRQoL, symptom severity, and pain among patients with PROS who were receiving treatment with alpelisib in the US. In addition, patients who had not been treated with alpelisib also participated in the quantitative part of the study by providing data on HRQoL, symptom severity, and pain, collected from a single administration of the web-based survey.
- Conditions
- PIK3CA-related Overgrowth Spectrum
- Being tested
- Alpelisib
- Keywords
- PIK3CA-related overgrowth spectrum, PROS, Alpelisib, NIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlpelisibOther
There was no treatment allocation. Patients administered alpelisib by prescription that were involved in Novartis' alpelisib managed access program were enrolled
| Study group | Role | What they receive |
|---|---|---|
| PROS patients treated with alpelisib | Patients with PROS who receive treatment with alpelisb Receives: Other: Alpelisib | |
| PROS patients not treated with alpelisib | Patients with PROS who don't receive treatment with apelisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS-29 + 2 profile for adult self-report
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 +2 profile.
The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Measured: Up to 4 months
PROMIS pediatric profile for adolescent self-Report and Caregiver-Proxy
The PROMIS Pediatric-25 Profile v2.0 is designed for self-report by children ages 8-17; It is designed for completion by a parent proxy on behalf of children ages 5-17. These assess depressive symptoms, anxiety, physical function-mobility, pain interference, fatigue, peer relationships, on a scale of 1 (worst) to 5 (best) and pain intensity scale ranging from 0 (no pain) to 10 (worst pain you can think of). The content of the pediatric and parent-proxy forms are identical, except for minor modifications to account for differences in responders (e.g., "I felt worried" vs "My child felt worried").
Measured: Up to 4 months
PROMIS pediatric sleep disturbance for Adolescent Self-Report and Caregiver-Proxy
The PROMIS sleep disturbance short form includes 4 items that assess difficulty falling asleep, sleeping through the night, problems with sleep, and trouble sleeping on a scale of 1 (worst) to 5 (best). In order to achieve similar domain coverage across the entire sample, the PROMIS Pediatric and Parent-Proxy Sleep Disturbance Short Form 4a will be administered to participants under the age of 18 and caregivers of children with PROS, since unlike the adult PROMIS Profile, the pediatric and parent-proxy PROMIS profile does not include a sleep disturbance domain.
Measured: Up to 4 months
EQ-5D-5L for Adult self-report
The EuroQoL-5 Dimension (EQ-5D-5L) is a simple, generic measure that includes only 5 basic domains common to many generic health status measures: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The form used in this study (EQ-5D-5L) has 5 response categories for each dimension (no problems, slight problems, moderate problems, severe problems and extreme problems). The EQ-5D-5L was developed for completion by adults
Measured: Up to 4 months
EQ-5D-Youth for adolescent Self-Report and Caregiver-Proxy
The EQ-5D-Y is based on the EQ-5D-3L but assesses the 5 dimensions using language that is more suitable to children/adolescents (the 5 dimensions are: mobility, looking after oneself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy). The 5 dimensions are answered using a 3-point response scale, where higher scores indicate better outcome.
The EQ-5D-Y also has a proxy version that assesses the same domains as the EQ-5D-Y.
Measured: Up to 4 months
Brief Pain Inventory for Adult Self-Report and Adolescent Self-Report
The BPI is a multi-item assessment of pain. This assessment includes 2 domains that, together, assess the overall pain experience: pain severity and pain interference. Three BPI items will be administered as part of the current study: one item assesses pain at its worst over the past 24 hours , one item assesses where on the body pain is experienced, and one item assesses the type of pain that is experienced. The worst pain item includes an 11-point response scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A diagram of the human body (front and back) is provided for responders to mark the areas of pain and the area that hurts the most. A series of descriptors (e.g., burning, tiring, and numb) will be provided for the responders to indicate whether each adjective applies to their pain. As this endpoint has not been adapted for proxy report, it will only be completed by adolescents and adults who are able to self-report.
Measured: Up to 4 months
Global impression of symptom severity
A single item will be fielded to all 3 groups of participants, asking for an assessment of the overall severity of symptoms experienced. This item includes 5 response options: no symptoms, mild, moderate, severe, and very severe. Minor modifications are made to the item wording to account for differences between adult/child self-report and caregiver proxy-report (e.g., changing "your overall symptoms" to "your child's overall symptoms").
Measured: Up to 4 months
Modified PROMIS dyspnea severity for adult Self-Report and Adolescent Self-Report
Two items will be used to assess a specific symptom: shortness of breath. These items are based on 2 items in the PROMIS Dyspnea Severity item bank, but with a 24-hour recall:
- Shortness of breath when walking up 10 stairs
- Shortness of breath when talking while walking The 2 PROMIS dyspnea severity items will be answered using a 5-point response scale: No shortness of breath, Mildly short of breath, Moderately short of breath, Severely short of breath, I did not do this in the past 24 hours.
There is no proxy version of the PROMIS Dyspnea Severity item bank, and thus the dyspnea severity items will not be administered to caregiver participants of the current study.
Measured: Up to 4 months
Secondary outcomes (1)
Description of change in HRQoL, symptom severity, and pain as a result of treatment
These descriptions will be provided by patients and caregivers during qualitative interviews.
Interview transcripts will be coded and analyzed by experienced members of the qualitative research team, using a 2-part thematic analysis approach. In addition to assigning data to a set of a priori codes (i.e., codes developed in advance and linked to the interview guide), the study team will also use a grounded theory approach, in which additional codes will be developed and refined in an on-going manner as the transcripts are reviewed and analyzed. This mix of coding methods will ensure key aspects of interest (e.g., concepts related to HRQoL, symptom severity, and pain) are addressed while still leaving room for new descriptions and experiences to be considered.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start16 May 2022
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PIK3CA-related Overgrowth SpectrumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05294289
- Sponsor's protocol ID
- CBYL719A0US14
- Status last verified
- Jun 2025
- First submitted
- 23 Feb 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health-related Quality of Life, Symptom Severity, and Pain Among Patients Treated With Alpelisib for PIK3CA-related Overgrowth Spectrum: A Mixed-methods Observational Study
- ClinicalTrials.gov ID
- NCT05294289
- Acronym / sponsor ID
- CBYL719A0US14
- Conditions
- PIK3CA-related Overgrowth Spectrum
- Keywords
- PIK3CA-related overgrowth spectrum, PROS, Alpelisib, NIS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 May 2022 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 24 Mar 2022 (actual)
- 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.
This was a mixed-methods observational study that incorporated both qualitative interviews and longitudinal quantitative data collection through an online survey (initial, 2 months, and 4 months).
Detailed description
This study collected qualitative data through interviews with patients and caregivers and qualitative data through a web-based longitudinal survey.
Both parts of the study were designed to collect information on HRQoL, symptom severity, and pain among patients with PROS who were receiving treatment with alpelisib in the US. In addition, patients who had not been treated with alpelisib also participated in the quantitative part of the study by providing data on HRQoL, symptom severity, and pain, collected from a single administration of the web-based survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROS patients treated with alpelisib | – | Other: AlpelisibPatients with PROS who receive treatment with alpelisb |
| PROS patients not treated with alpelisib | – | –Patients with PROS who don't receive treatment with apelisib |
Who may qualify
- Ages
- 5 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three groups of of participants were included: * Adults with PROS who are capable of independently completing the required Clinical Outcome Assessments (adult self-report) * Adolescents, between the ages of 12 and 17 (inclusive), with PROS who are capable of independently completing the required Clinical Outcome Assessments, as assessed by a legal guardian (adolescent self-report). * Caregivers of children/adolescents with PROS (caregivers proxy-report). these must be parents or legal guardians whose children are between the ages of 5 and 11, or adolescents between the ages of 12 and 17 who are unable to independently complete the required Clinical Outcome Assessments.
Key inclusion criteria (56 listed)
- At least 18 years of age
- Self-reports having been diagnosed with 1 of the following syndromes:
- Able to converse and read/answer survey questions in English
- Willing and able to provide informed consent
- Adolescent patients
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria. However, participants may be excluded if the quota related to alpelisib treatment (60 treated with alpelisib; 40 not treated with alpelisib) has been achieved. For example, if 40 participants not treated with alpelisib have been recruited into the study, any additional participants not treated with alpelisib will be excluded. Patients treated with alpelisib may be similarly excluded if the quota of 60 patients has already been achieved.
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 |
|---|---|---|
| AlpelisibThere was no treatment allocation. Patients administered alpelisib by prescription that were involved in Novartis' alpelisib managed access program were enrolled | Other | PROS patients treated with alpelisib |
Primary outcome
PROMIS-29 + 2 profile for adult self-report
Time frame: Up to 4 months
Patient-Reported Outcomes Measurement Information System (PROMIS)-29 +2 profile. The PROMIS-29 plus 2 Profile v2.1 is designed for adults ≥18 years of age and includes 29 items across the following domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, ability to participate in social roles and activities, cognitive function on a scale of 1 (worst) to 5 (best), and pain intensity (on a scale ranging from 0 (no pain) to 10 (worst pain imaginable).
PROMIS pediatric profile for adolescent self-Report and Caregiver-Proxy
Time frame: Up to 4 months
The PROMIS Pediatric-25 Profile v2.0 is designed for self-report by children ages 8-17; It is designed for completion by a parent proxy on behalf of children ages 5-17. These assess depressive symptoms, anxiety, physical function-mobility, pain interference, fatigue, peer relationships, on a scale of 1 (worst) to 5 (best) and pain intensity scale ranging from 0 (no pain) to 10 (worst pain you can think of). The content of the pediatric and parent-proxy forms are identical, except for minor modifications to account for differences in responders (e.g., "I felt worried" vs "My child felt worried").
PROMIS pediatric sleep disturbance for Adolescent Self-Report and Caregiver-Proxy
Time frame: Up to 4 months
The PROMIS sleep disturbance short form includes 4 items that assess difficulty falling asleep, sleeping through the night, problems with sleep, and trouble sleeping on a scale of 1 (worst) to 5 (best). In order to achieve similar domain coverage across the entire sample, the PROMIS Pediatric and Parent-Proxy Sleep Disturbance Short Form 4a will be administered to participants under the age of 18 and caregivers of children with PROS, since unlike the adult PROMIS Profile, the pediatric and parent-proxy PROMIS profile does not include a sleep disturbance domain.
EQ-5D-5L for Adult self-report
Time frame: Up to 4 months
The EuroQoL-5 Dimension (EQ-5D-5L) is a simple, generic measure that includes only 5 basic domains common to many generic health status measures: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The form used in this study (EQ-5D-5L) has 5 response categories for each dimension (no problems, slight problems, moderate problems, severe problems and extreme problems). The EQ-5D-5L was developed for completion by adults
EQ-5D-Youth for adolescent Self-Report and Caregiver-Proxy
Time frame: Up to 4 months
The EQ-5D-Y is based on the EQ-5D-3L but assesses the 5 dimensions using language that is more suitable to children/adolescents (the 5 dimensions are: mobility, looking after oneself, doing usual activities, having pain or discomfort, and feeling worried, sad, or unhappy). The 5 dimensions are answered using a 3-point response scale, where higher scores indicate better outcome. The EQ-5D-Y also has a proxy version that assesses the same domains as the EQ-5D-Y.
Brief Pain Inventory for Adult Self-Report and Adolescent Self-Report
Time frame: Up to 4 months
The BPI is a multi-item assessment of pain. This assessment includes 2 domains that, together, assess the overall pain experience: pain severity and pain interference. Three BPI items will be administered as part of the current study: one item assesses pain at its worst over the past 24 hours , one item assesses where on the body pain is experienced, and one item assesses the type of pain that is experienced. The worst pain item includes an 11-point response scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). A diagram of the human body (front and back) is provided for responders to mark the areas of pain and the area that hurts the most. A series of descriptors (e.g., burning, tiring, and numb) will be provided for the responders to indicate whether each adjective applies to their pain. As this endpoint has not been adapted for proxy report, it will only be completed by adolescents and adults who are able to self-report.
Global impression of symptom severity
Time frame: Up to 4 months
A single item will be fielded to all 3 groups of participants, asking for an assessment of the overall severity of symptoms experienced. This item includes 5 response options: no symptoms, mild, moderate, severe, and very severe. Minor modifications are made to the item wording to account for differences between adult/child self-report and caregiver proxy-report (e.g., changing "your overall symptoms" to "your child's overall symptoms").
Modified PROMIS dyspnea severity for adult Self-Report and Adolescent Self-Report
Time frame: Up to 4 months
Two items will be used to assess a specific symptom: shortness of breath. These items are based on 2 items in the PROMIS Dyspnea Severity item bank, but with a 24-hour recall: * Shortness of breath when walking up 10 stairs * Shortness of breath when talking while walking The 2 PROMIS dyspnea severity items will be answered using a 5-point response scale: No shortness of breath, Mildly short of breath, Moderately short of breath, Severely short of breath, I did not do this in the past 24 hours. There is no proxy version of the PROMIS Dyspnea Severity item bank, and thus the dyspnea severity items will not be administered to caregiver participants of the current study.
1 secondary outcome
Description of change in HRQoL, symptom severity, and pain as a result of treatment
Time frame: 4 months
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 24 Jun 2025.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PIK3CA-related Overgrowth Spectrum, run by Novartis Pharmaceuticals 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 56 inclusion and 1 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 24 Jun 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
PROMIS-29 + 2 profile for adult self-report (time frame: Up to 4 months). The study lists 8 primary outcomes in all. 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 24 Jun 2025.