Crohn's DiseaseENvISIONNCT04131504
Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
An observational study of Crohn's Disease and IBD, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial summary
Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents. Physicians need better ways to inform decisions on therapy selection and recognize ongoing intestinal injury while on treatment. Read more about this study
- Who is it for?
- Ages 1 year to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease, IBD
- What is being tested?
- Infliximab and Adalimumab
- How many people
- 239 participants
- Where
- 4 sitesUnited States
- Study dates
- 16 Oct 2019to 31 Oct 2023
- 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 1 year to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Potential IBD participants will be recruited through the Division of Gastroenterology at each participating site. Healthy volunteers will be recruited from through direct advertising methods approved by the IRB and formal local databases intended for recruitment.
Who may be able to join
- Age criteria: > 1 year to < 22 years of age
- Diagnosis of Crohn's disease, anti-TNF naïve, and colonoscopy scheduled OR
- Clinical suspicion for IBD (treatment naïve) and colonoscopy scheduled
- Permission of parent/guardian and assent or consent of research participant
- Age criteria: > 1 year to < 22 years of age
- Any CCHMC patient
Show all 14Show fewer
- Permission of parent/guardian and assent or consent of research participant
- Age criteria: > 1 year to < 22 years of age
- Diagnosis of Crohn's disease with:
- Luminal inflammation (ulcerations in ileum and/or colon visible by ileocolonoscopy) and
- Endoscopic evidence of active Crohn's disease (up to 90 days prior to starting anti-TNF) OR if no colonoscopy within 90 days then fecal calprotectin ≥250 µg/g or fecal lactoferrin >10 µg/g (<90 days from starting anti-TNF)
- Anti-TNF naïve
- Starting infliximab or adalimumab (or either biosimilar)
- Permission of parent/guardian and assent or consent of research participant
Who cannot join
- Any prior treatment with an anti-TNF, such as infliximab, adalimumab, certolizumab or golimumab
- Known diagnosis of ulcerative colitis (UC) or inflammatory bowel disease-unspecified (IBD-U)
- Active or prior evidence of internal (abdominal/pelvic) penetrating fistula(e)
- Active intra-abdominal abscess or perianal abscess
- Active Clostridium difficile infection or other known enteric infection in last 2 weeks
- Current ileostomy or colostomy, extensive small bowel resection, ileoanal pouch or short bowel syndrome
Show all 25Show fewer
- History of autoimmune disease (including autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)
- Any condition that in the opinion of the PI will prevent the research participant from taking part in this study
- Phase I - Cross-sectional Study (healthy volunteers)
- Known diagnosis of one or more of the following: irritable bowel syndrome, gastroesophageal reflux, constipation, BMI>95% for age, small intestinal bacterial overgrowth (SIBO) or history of intestinal polyps
- Received any antibiotic in the last 30 days or known viral or bacterial illness in the last 30 days
- Any NSAID use in the last 14 days
- History of an autoimmune disease (including diabetes, autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)
- Any condition that in the opinion of the PI will prevent the research participant from taking part in this study
- Phase II - Longitudinal Study of Participants with CD
- Crohn's disease limited to esophagus, stomach, duodenum or jejunum
- Prior treatment with infliximab, adalimumab, certolizumab or golimumab
- Known diagnosis of Ulcerative colitis (UC) or inflammatory bowel disease-unspecified (IBD-U)
- Active or prior evidence of internal (abdominal/pelvic) penetrating fistula(e)
- Active intra-abdominal abscess or perianal abscess
- Active Clostridium difficile infection or other known enteric infection in last 2 weeks
- Current ileostomy or colostomy, extensive small bowel resection, ileoanal pouch or short bowel syndrome
- History of autoimmune disease (including autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)
- Contraindications to MRI scanning, such as metal implants/non-compatible medical devices or medical conditions
- Any condition that in the opinion of the PI will prevent the research participant from taking part in this study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Connecticut Children's Medical Center
Hartford, Connecticut, 06016
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF
Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents. Physicians need better ways to inform decisions on therapy selection and recognize ongoing intestinal injury while on treatment.
The main reason for this research study is to see if a blood test or stool test, which measures specific proteins, taken just before starting a new treatment for Crohn's disease can predict a patient's ability to achieve complete intestinal healing. The investigators also want to see if the intensity of gut inflammation can be detected by measuring a separate set of proteins in the blood.
Read the detailed description
Despite the heterogeneity of CD phenotypes and a potentially aggressive course of inadequately treated CD, treatment selection for newly diagnosed patients is currently based on clinical factors which do not define CD sub-types. Now, with additional biologic therapies for CD, there is a critical need for individual biochemical analysis both pre-treatment, and following induction to assess the probability of durable remission. These data will inform decisions on continued dosing of the current biologic, or whether addition of combination therapy or switching to a therapy with an alternative mechanism of action will be more beneficial.
The Food \& Drug Administration (FDA) defines a companion diagnostic as a device that can identify patients most likely to benefit from a therapy or a device to monitor response with the purpose to adjust the treatment to achieve improved effectiveness.Our global aim is to develop a companion diagnostic (peripheral blood panel) that accurately predicts the probability of deep remission (clinical remission with MH) to anti-TNF and a protein (blood) biomarker panel that reproducibly distinguishes endoscopic MH from active (ulcerated) intestinal inflammation in patients with CD.
The long-term strategy is to utilize the "low-risk" anti-TNF specific module (protein panel) to personalize CD therapy. With the addition of new biologics for CD, patients with a low-risk inflammatory profile would not only be expected to achieve MH but also predicted to respond to treatment escalation strategies while avoiding or stopping the drug (if drug exposure is optimized) sooner in patients in which the protein profile predicts a low probability of deep remission with anti-TNF. As additional therapies are approved for pediatric CD, the priority would be to avoid anti-TNF in patients with a "high-risk" protein profile and specifically select therapies that target the patient's individual inflammatory signature. Additionally, the investigators expect the protein profile of patients failing to achieve deep remission to provide further insight into molecular mechanisms contributing to the continued inflammation and thereby directing the next therapeutic option.
- Conditions
- Crohn's Disease, IBD
- Being tested
- Infliximab, Adalimumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Remicade
No standard dosing regimen will be used and the dose will be determined by the treating physician
AdalimumabDrug
Also called Humira
No standard dosing regimen will be used and the dose will be determined by the treating physician
| Study group | Role | What they receive |
|---|---|---|
| Phase I - Cross-sectional Study (CD and Suspected IBD) | 150 children and young adults who have been previously diagnosed with CD (anti-TNF naïve) or suspected of having IBD (based on clinical symptoms and laboratory testing) who are scheduled for a clinically-indicated colonoscopy are eligible to be enrolled in this cohort. | |
| Phase I - Cross-sectional Study (healthy volunteers) | 20 healthy controls will be enrolled at Cincinnati Children's Hospital only. Once demographics, past medical/surgical history and biospecimens (blood/stool) are collected, controls will complete participation. | |
| Phase II - Longitudinal Study of Participants with CD | 70 children and young adults who have been diagnosed with CD (anti-TNF naïve) and are scheduled to receive infliximab (or adalimumab) are eligible to be enrolled in this cohort. Receives: Drug: Infliximab; Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Deep Remission
Sustained Deep Remission, defined as meeting all of the following at 1 year (check all that apply):
- no wPCDAI score of ≥12.5 on two consecutive visits between week 30-52
- wPCDAI at week 52 is <12.5
- off prednisone between weeks 30-52
- endoscopic remission (SES-CD<3)
Measured: 1 year
Secondary outcomes (24)
End of Induction Outcomes: Clinical Response
Improvement of >17.5 points from baseline wPCDAI and/or Week 16 wPCDAI= <12.5 points
Measured: Week 16
End of Induction Outcomes: Clinical Remission
wPCDAI <12.5 at Week 16
Measured: Week 16
End of Induction Outcomes: Steroid Free Clinical Remission
wPCDAI <12.5 and off prednisone by Week 16
Measured: Week 16
End of Induction Outcomes: Fecal Biochemical Response
Fecal calprotectin improved >50% from baseline stool (+/- 30 days from Week 16)
Measured: Week 16
End of Induction Outcomes: Fecal Biochemical Remission
Fecal calprotectin <250µg/g at Week 16 (+/- 30 days)
Measured: Week 16
End of Induction Outcomes: Blood CRP Biochemical Remission
CRP <0.5 mg/dL at Week 16
Measured: Week 16
End of Induction Outcomes: Blood CD64 Biochemical Remission
nCD64 <4.5 at Week 16
Measured: Week 16
Week 52 Outcomes: Endoscopic Response
50% reduction in SES-CD score from baseline SES-CD (if performed)
Measured: 1 year
Week 52 Outcomes: Endoscopic Remission
SES-CD <3
Measured: 1 year
Week 52 Outcomes: Minimal Endoscopic Activity
SES-CD <6 with no individual SES-CD subscore >1
Measured: 1 year
Week 52 Outcomes: Complete Intestinal Healing
SES-CD = 0
Measured: 1 year
Week 52 Outcomes: Sustained, Steroid-free Clinical Remission
wPCDAI <12.5 for all visits from weeks 30-52, off prednisone
Measured: 1 year
Week 52 Outcomes: Clinical Remission
wPCDAI <12.5 and off prednisone at last study visit
Measured: 1 year
Week 52 Outcomes: Clinical Remission and Endoscopic Response
wPCDAI <12.5 at week 52 and SES-CD>50% reduction from baseline
Measured: 1 year
Week 52 Outcomes: Clinical Remission and Minimal Endoscopic Activity
wPCDAI <12.5 at week 52 and SES-CD<6 with no individual SES-CD subscore >1
Measured: 1 year
Week 52 Outcomes: Treatment Response
continues on anti-TNF without surgery, hospitalization and off prednisone by week 16
Measured: 1 year
Week 52 Outcomes: Transmural ileal healing
ileum subscore stage 0 (score = 0) or stage 1 (score 1-3)
Measured: 1 year
Week 52 Outcomes: Transmural colonic healing
all segments of colon subscore stage 0 (score=0) or stage 1 (score 1-3)
Measured: 1 year
Week 52 Outcomes: Total Bowel Transmural healing
total ileum and colonic subscore is not greater than stage 1 on either individual score
Measured: 1 year
Week 52 Outcomes: Fecal Biochemical Remission
fecal calprotectin <250 µg/g at week 52
Measured: 1 year
Week 52 Outcomes: Deep Fecal Biochemical Remission
fecal calprotectin <150 µg/g at week 52
Measured: 1 year
Week 52 Outcomes: CRP Biochemical Remission
CRP <0.5 mg/dL at week 52
Measured: 1 year
Week 52 Outcomes: CD64 Biochemical Remission
nCD64 <4.5 at week 52
Measured: 1 year
Week 52 Outcomes: PGA Remission
physician-rated PGA is quiescent and subject is off prednisone
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start16 Oct 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Phillip Minar, MD, MS, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04131504
- Sponsor's protocol ID
- 2019-0730
- Acronym
- ENvISION
- Status last verified
- Jan 2024
- First submitted
- 16 Oct 2019
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Velez Lopez A, Waddell A, Antonacci S, Castillo D, Santucci N, Ollberding NJ, Eshleman EM, Denson LA, Alenghat T. Microbiota-derived butyrate dampens linaclotide stimulation of the guanylate cyclase C pathway in patient-derived colonoids. Neurogastroenterol Motil. 2023 Dec;35(12):e14681. doi: 10.1111/nmo.14681. Epub 2023 Sep 22.
PubMed 37736865
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Study to Discover a Companion Diagnostic for Biologics Targeting TNF
- ClinicalTrials.gov ID
- NCT04131504
- Acronym / sponsor ID
- ENvISION / 2019-0730
- Conditions
- Crohn's Disease, IBD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 18 Oct 2019 (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.
Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents. Physicians need better ways to inform decisions on therapy selection and recognize ongoing intestinal injury while on treatment.
The main reason for this research study is to see if a blood test or stool test, which measures specific proteins, taken just before starting a new treatment for Crohn's disease can predict a patient's ability to achieve complete intestinal healing. The investigators also want to see if the intensity of gut inflammation can be detected by measuring a separate set of proteins in the blood.
Detailed description
Despite the heterogeneity of CD phenotypes and a potentially aggressive course of inadequately treated CD, treatment selection for newly diagnosed patients is currently based on clinical factors which do not define CD sub-types. Now, with additional biologic therapies for CD, there is a critical need for individual biochemical analysis both pre-treatment, and following induction to assess the probability of durable remission. These data will inform decisions on continued dosing of the current biologic, or whether addition of combination therapy or switching to a therapy with an alternative mechanism of action will be more beneficial.
The Food \& Drug Administration (FDA) defines a companion diagnostic as a device that can identify patients most likely to benefit from a therapy or a device to monitor response with the purpose to adjust the treatment to achieve improved effectiveness.Our global aim is to develop a companion diagnostic (peripheral blood panel) that accurately predicts the probability of deep remission (clinical remission with MH) to anti-TNF and a protein (blood) biomarker panel that reproducibly distinguishes endoscopic MH from active (ulcerated) intestinal inflammation in patients with CD.
The long-term strategy is to utilize the "low-risk" anti-TNF specific module (protein panel) to personalize CD therapy. With the addition of new biologics for CD, patients with a low-risk inflammatory profile would not only be expected to achieve MH but also predicted to respond to treatment escalation strategies while avoiding or stopping the drug (if drug exposure is optimized) sooner in patients in which the protein profile predicts a low probability of deep remission with anti-TNF. As additional therapies are approved for pediatric CD, the priority would be to avoid anti-TNF in patients with a "high-risk" protein profile and specifically select therapies that target the patient's individual inflammatory signature. Additionally, the investigators expect the protein profile of patients failing to achieve deep remission to provide further insight into molecular mechanisms contributing to the continued inflammation and thereby directing the next therapeutic option.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I - Cross-sectional Study (CD and Suspected IBD) | – | –150 children and young adults who have been previously diagnosed with CD (anti-TNF naïve) or suspected of having IBD (based on clinical symptoms and laboratory testing) who are scheduled for a clinically-indicated colonoscopy are eligible to be enrolled in this cohort. |
| Phase I - Cross-sectional Study (healthy volunteers) | – | –20 healthy controls will be enrolled at Cincinnati Children's Hospital only. Once demographics, past medical/surgical history and biospecimens (blood/stool) are collected, controls will complete participation. |
| Phase II - Longitudinal Study of Participants with CD | – | Drug: Infliximab, Drug: Adalimumab70 children and young adults who have been diagnosed with CD (anti-TNF naïve) and are scheduled to receive infliximab (or adalimumab) are eligible to be enrolled in this cohort. |
Who may qualify
- Ages
- 1 year to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Potential IBD participants will be recruited through the Division of Gastroenterology at each participating site. Healthy volunteers will be recruited from through direct advertising methods approved by the IRB and formal local databases intended for recruitment.
Key inclusion criteria (14 listed)
- Age criteria: > 1 year to < 22 years of age
- Diagnosis of Crohn's disease, anti-TNF naïve, and colonoscopy scheduled OR
- Clinical suspicion for IBD (treatment naïve) and colonoscopy scheduled
- Permission of parent/guardian and assent or consent of research participant
- Age criteria: > 1 year to < 22 years of age
Key exclusion criteria (25 listed)
- Any prior treatment with an anti-TNF, such as infliximab, adalimumab, certolizumab or golimumab
- Known diagnosis of ulcerative colitis (UC) or inflammatory bowel disease-unspecified (IBD-U)
- Active or prior evidence of internal (abdominal/pelvic) penetrating fistula(e)
- Active intra-abdominal abscess or perianal abscess
- Active Clostridium difficile infection or other known enteric infection in last 2 weeks
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: RemicadeNo standard dosing regimen will be used and the dose will be determined by the treating physician | Drug | Phase II - Longitudinal Study of Participants with CD |
| AdalimumabAlso: HumiraNo standard dosing regimen will be used and the dose will be determined by the treating physician | Drug | Phase II - Longitudinal Study of Participants with CD |
Primary outcome
Sustained Deep Remission
Time frame: 1 year
Sustained Deep Remission, defined as meeting all of the following at 1 year (check all that apply): * no wPCDAI score of ≥12.5 on two consecutive visits between week 30-52 * wPCDAI at week 52 is <12.5 * off prednisone between weeks 30-52 * endoscopic remission (SES-CD<3)
24 secondary outcomes
End of Induction Outcomes: Clinical Response
Time frame: Week 16
End of Induction Outcomes: Clinical Remission
Time frame: Week 16
End of Induction Outcomes: Steroid Free Clinical Remission
Time frame: Week 16
End of Induction Outcomes: Fecal Biochemical Response
Time frame: Week 16
End of Induction Outcomes: Fecal Biochemical Remission
Time frame: Week 16
End of Induction Outcomes: Blood CRP Biochemical Remission
Time frame: Week 16
End of Induction Outcomes: Blood CD64 Biochemical Remission
Time frame: Week 16
Week 52 Outcomes: Endoscopic Response
Time frame: 1 year
Week 52 Outcomes: Endoscopic Remission
Time frame: 1 year
Week 52 Outcomes: Minimal Endoscopic Activity
Time frame: 1 year
Week 52 Outcomes: Complete Intestinal Healing
Time frame: 1 year
Week 52 Outcomes: Sustained, Steroid-free Clinical Remission
Time frame: 1 year
Week 52 Outcomes: Clinical Remission
Time frame: 1 year
Week 52 Outcomes: Clinical Remission and Endoscopic Response
Time frame: 1 year
Week 52 Outcomes: Clinical Remission and Minimal Endoscopic Activity
Time frame: 1 year
Week 52 Outcomes: Treatment Response
Time frame: 1 year
Week 52 Outcomes: Transmural ileal healing
Time frame: 1 year
Week 52 Outcomes: Transmural colonic healing
Time frame: 1 year
Week 52 Outcomes: Total Bowel Transmural healing
Time frame: 1 year
Week 52 Outcomes: Fecal Biochemical Remission
Time frame: 1 year
Week 52 Outcomes: Deep Fecal Biochemical Remission
Time frame: 1 year
Week 52 Outcomes: CRP Biochemical Remission
Time frame: 1 year
Week 52 Outcomes: CD64 Biochemical Remission
Time frame: 1 year
Week 52 Outcomes: PGA Remission
Time frame: 1 year
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 30 Jan 2024.
- Derived from this study: PubMed 37736865Velez Lopez A, Waddell A, Antonacci S, Castillo D, Santucci N, Ollberding NJ, Eshleman EM, Denson LA, Alenghat T. Microbiota-derived butyrate dampens linaclotide stimulation of the guanylate cyclase C pathway in patient-derived colonoids. Neurogastroenterol Motil. 2023 Dec;35(12):e14681. doi: 10.1111/nmo.14681. Epub 2023 Sep 22.
- 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.
Phillip Minar, MD, MS principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and IBD, run by Children's Hospital Medical Center, Cincinnati at 4 sites 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 14 inclusion and 25 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Sustained Deep Remission (time frame: 1 year). 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 NCT04131504, 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 30 Jan 2024.