PreeclampsiaPhase 2CRUSHNCT04725812
Complement Regulation to Undo Systemic Harm in Preeclampsia
A Phase 2 study testing Eculizumab in people with Preeclampsia and Severe Preeclampsia, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This is a Phase II, single arm, open-label study to determine if treatment with eculizumab prolongs pregnancy compared to historical controls in women with preeclampsia between 23-30 weeks gestation. Read more about this study
- Who is it for?
- Ages 13 years and older, women only
- Conditions the study is for
- Preeclampsia, Severe Preeclampsia, Eculizumab
- What is being tested?
- Eculizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 7 Dec 2021
- 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 13 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures \& availability for study duration
- Biologically female, aged ≥13, body weight ≥40kg
- Diagnosed with preeclampsia between 23-29+6/7 weeks gestation, by following criteria:
- Blood pressure ≥160 mmHg systolic or ≥110 mmHg diastolic OR
- Blood pressure ≥140 mmHg systolic or ≥90 mmHg diastolic and at least one of the following
Show all 9Show fewer
- Proteinuria (spot protein/creatinine ≥0.3mg/mg or 24Hr protein ≥300 mg) ii. Platelet count <100,000/μl iii. Aspartate or alanine transaminase >2x upper limit of normal iv. Creatinine >1.1 mg/dl or oliguria v. Pulmonary edema
- Ability to take intravenous medication and be willing to adhere to the eculizumab regimen
- Ability to receive meningococcal vaccine and be willing to adhere to antibiotic regimen
Who cannot join
- An individual who meets any of the following criteria prior to enrollment will be excluded from participation in this study:
- Known allergic reactions eculizumab or meningococcal vaccine
- Febrile illness within prior 2 weeks
- Treatment with another investigational drug within previous 6 months
- Inpatient expectant management for preeclampsia >72 hours prior to enrollment
- Fetal contraindication to expectant management of pregnancy
Show all 42Show fewer
- Platelet count <50,000/μl
- Diagnosis of hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
- Must meet all of the following criteria to be excluded: LDH >600 U/L, platelet count < 100,000/μl, AST >2x upper limit of normal, ALT >2x upper limit of normal
- Diagnosis of Eclampsia
- Diagnosis of Placental abruption
- Intrauterine fetal demise
- Coagulopathy (INR ≥ 1.5)
- Fibrinogen <200 mg/dl
- Persistent, severe headache unresponsive to medications
- Persistent, severe visual disturbances
- Persistent, severe epigastric or RUQ pain unresponsive to medications
- Diagnosis of Systemic lupus erythematosus
- Diagnosis of Anti-phospholipid antibody syndrome
- Diagnosis of Atypical hemolytic uremic syndrome
- Diagnosis of Paroxysmal nocturnal hemoglobinuria
- Known complement deficiency
- Diagnosis of Venous thromboembolism active or within 6 months of enrollment
- Diagnosis of Human immunodeficiency virus (HIV)
- Diagnosis of Hepatitis C virus (active viremia)
- Diagnosis of Cancer (not in remission)
- History of Solid organ transplant
- Systemic viral or bacterial infection (active, untreated)
- Active use of eculizumab at time of enrollment
- Contraindication to eculizumab treatment or complement system blockade
- Contraindication to meningococcal vaccine
- Body weight <40kg
- Age <13
- Neutropenia (<1500/mm3)
- Gonorrhea, chlamydia, or syphilis in current pregnancy
- Illicit substance use in current pregnancy
- Currently homeless or incarcerated
- Alcoholism
- Liver cirrhosis
- Insulin dependent diabetes
- Active use of immunosuppressive therapies, other than use of corticosteroids for fetal lung maturity
- Use of prophylactic or therapeutic heparin, or low molecular weight heparin, in pregnancy for hypercoagulable condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study
This is a Phase II, single arm, open-label study to determine if treatment with eculizumab prolongs pregnancy compared to historical controls in women with preeclampsia between 23-30 weeks gestation.
Read the detailed description
The purpose of this study is to determine if eculizumab is an effective treatment to prolong pregnancy in women with preeclampsia, compared to a historical control group of women that received standard of care alone. Eligible subjects will be women with preeclampsia before 30 weeks gestation, who have been deemed suitable for prolongation of pregnancy.
The primary research procedure is administration of the study drug, eculizumab, by intravenous infusions weekly for four weeks, then every other week. Eculizumab is approved by the FDA for the treatment of women with atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria and is frequently used in pregnant women with these disorders. However, eculizumab is considered investigational in this study because it has not been approved by the FDA for use in patients with preeclampsia. Subject participation will last approximately 8-12 weeks on average, and the study drug will be continued until 48 hours after delivery in the treatment arm. All subjects will be followed at 2 weeks and 6 weeks after delivery to assess maternal and neonatal outcomes. A later visit may be required to complete the meningococcal vaccine schedule.
The investigators believe that eculizumab will prolong pregnancy in women with preeclampsia diagnosed before 30 weeks gestation with overactive complement. As there is no effective treatment for preeclampsia other than delivery currently, women with preeclampsia before 30 weeks gestation are managed using a "watch and wait" approach (i.e., expectant management). Due to the unpredictable nature of preeclampsia, expectant management places mother and child at significant risk until delivery occurs. Eculizumab may be an improvement over current standard of care as it provides a treatment option for patients who would otherwise be managed with expectant management alone. If the study aims are achieved, eculizumab will emerge as an effective treatment option for women with preeclampsia.
- Conditions
- Preeclampsia, Severe Preeclampsia, Eculizumab, HELLP, HELLP Syndrome, HELLP Syndrome Second Trimester
- Being tested
- Eculizumab
- Medical subject headings
- Pre-Eclampsia, HELLP Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EculizumabDrug
Also called Soliris
Eculizumab Intravenous Solution
| Study group | Role | What they receive |
|---|---|---|
| Eculizumab | Experimental | Twelve subjects in the interventional arm will receive eculizumab at an induction dose of 900mg IV weekly (q7 days) for 4 weeks followed by a dose of 1200mg IV at week 5. Thereafter, patients will receive a maintenance dose of 1200mg IV every two weeks (q14 days). The last dose of eculizumab will be given up to 48 hours post-partum, with a dose that is dependent on the dosing schedule (i.e. whether the last dose is given within the 4-week induction period or is during the maintenance phase). Receives: Drug: Eculizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency (in Days) From Enrollment to Delivery
The difference in mean number of days (latency) from enrollment in the study (or hospital admission for controls) to delivery between participant receiving eculizumab compared to historical controls.
- For treatment-arm participants latency is determined from enrollment to delivery.
- For historical controls latency is determined from hospital admission (or initial diagnosis for controls hospitalized for other indication) for preeclampsia until delivery.
- Subjects and historical controls all defined as women with preeclampsia between 23-30 weeks gestation.
Measured: 24 months
Secondary outcomes (16)
Composite Adverse Maternal Outcomes
The difference in the composite number of adverse maternal outcomes between subjects receiving eculizumab compared to historical controls
•Adverse maternal outcomes directly attributed to preeclampsia defined as the following: syndrome of hemolysis, elevated liver enzyme, and low platelet count (HELLP), eclampsia, placental abruption, stroke, venous thrombosis or pulmonary embolism, pulmonary edema, posterior reversible encephalopathy syndrome, postpartum hemorrhage (>1000 cc), blood transfusion, admission to the intensive care unit, acute kidney injury, acute tubular necrosis, dialysis, or death
Measured: 24 months
Composite Adverse Neonatal Outcomes
The difference in the composite number of adverse neonatal outcomes between subjects receiving eculizumab compared to historical controls.
•Adverse neonatal outcomes directly attributable to preeclampsia or indirectly attributable due to preterm delivery due to preeclampsia defined as the following: Respiratory distress syndrome, bronchopulmonary dysplasia, intraventricular hemorrhage, retinopathy of prematurity, necrotizing enterocolitis, seizure, hypoxic-ischemic encephalopathy, metabolic acidosis, infection, sepsis, previously unrecognized major malformation detected at birth, patent ductus arteriosus requiring indomethacin, or death.
Measured: 24 months
Changes in Blood and Urine Concentrations of Terminal Complement Protein C5a Before and After Each Treatment.
The Difference in the concentration of C5a in blood and urine, before treatment ( ex. visit day 1) compared to after treatment in each participant receiving eculizumab.
•Concentrations of C5a in blood and urine will be determined by enzyme linked immunosorbent assays (ELISA).
Measured: 24 months
Changes in Blood and Urine Concentrations of Terminal Complement Protein C5b-9 Before and After Each Treatment.
The difference in blood and urine concentrations of C5b-9, before treatment ( ex. visit day 1) compared to after treatment in each participant receiving eculizumab.
Measured: 24 months
Changes in Blood and Urine Concentrations of Complement Protein CD59 Before and After Each Treatment.
The difference in blood and urine concentrations of CD59, before treatment ( ex. visit day 1) compared to after treatment in each participant receiving eculizumab.
Measured: 24 months
Aspartate and Alanine Transaminase Concentration Before and After Each Treatment.
Differences in the concentration of aspartate and alanine transaminase (U/L) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Hemoglobin Concentration Before and After Each Treatment.
Differences in the concentrations of measures of hemoglobin will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Platelet Count Before and After Each Treatment.
Differences in the platelet count will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Lactate Dehydrogenase Concentration Before and After Each Treatment.
Differences in the concentration of serum lactate dehydrogenase will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Serum Creatinine Before and After Each Treatment.
Differences in the concentration of serum creatinine will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Urine Protein Concentration Before and After Each Treatment.
Differences in urine protein concentration will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Ratio of Urine Protein to Urine Creatinine Before and After Each Treatment.
Differences in the ratio of urine protein concentration to urine creatinine concentration will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Serum Concentration of Soluble Fms-like Tyrosine Kinase 1 (sFlt-1) Before and After Each Treatment.
Differences in the concentration of soluble fms-like tyrosine kinase 1 (sFlt-1) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Serum Concentration of Placental Growth Factor (PlGF) Before and After Each Treatment.
Differences in the concentration of placental growth factor (PlGF) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Serum Ratio of Soluble Fms-like Tyrosine Kinase 1 (sFlt-1) Concentration to Placental Growth Factor (PlGF) Concentration (sFlt-1/PlGF) Before and After Each Treatment.
Differences in the serum ratio of soluble fms-like tyrosine kinase 1 (sFlt-1) concentration to placental growth factor (PlGF) concentration (sFlt-1/PlGF) will be compared before treatment (ex. visit day 1) and after treatment in each participant receiving eculizumab.
Measured: 24 months
Serious Adverse Events
Assessment of serious adverse events in eculizumab treatment arm compared with historical controls.
- Neisseria meningitidis infection or development of invasive meningococcal disease, Neisseria gonorrhoeae, Neisseria sicca/subflava, and Neisseria spp unspecified and Aspergillus infections.
- Graded clinical and laboratory abnormalities, according to the U.S. Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of AIDS; DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1. [July 2017].
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start13 Sep 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Why it stopped: PI moved institutions
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 PreeclampsiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm open label study.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, S Ananth Karumanchi, Cedars-Sinai Medical Center
- Investigators
- Richard Burwick, MD, MPH, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725812
- Sponsor's protocol ID
- STUDY00000039
- Acronym
- CRUSH
- Status last verified
- Nov 2023
- First submitted
- 19 Jan 2021
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complement Regulation to Undo Systemic Harm in Preeclampsia: The CRUSH Study
- ClinicalTrials.gov ID
- NCT04725812
- Acronym / sponsor ID
- CRUSH / STUDY00000039
- Conditions
- Preeclampsia, Severe Preeclampsia, Eculizumab, HELLP, HELLP Syndrome, HELLP Syndrome Second Trimester
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI moved institutions
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Alexion Pharmaceuticals, Inc.
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Posted 29 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, single arm, open-label study to determine if treatment with eculizumab prolongs pregnancy compared to historical controls in women with preeclampsia between 23-30 weeks gestation.
Detailed description
The purpose of this study is to determine if eculizumab is an effective treatment to prolong pregnancy in women with preeclampsia, compared to a historical control group of women that received standard of care alone. Eligible subjects will be women with preeclampsia before 30 weeks gestation, who have been deemed suitable for prolongation of pregnancy.
The primary research procedure is administration of the study drug, eculizumab, by intravenous infusions weekly for four weeks, then every other week. Eculizumab is approved by the FDA for the treatment of women with atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria and is frequently used in pregnant women with these disorders. However, eculizumab is considered investigational in this study because it has not been approved by the FDA for use in patients with preeclampsia. Subject participation will last approximately 8-12 weeks on average, and the study drug will be continued until 48 hours after delivery in the treatment arm. All subjects will be followed at 2 weeks and 6 weeks after delivery to assess maternal and neonatal outcomes. A later visit may be required to complete the meningococcal vaccine schedule.
The investigators believe that eculizumab will prolong pregnancy in women with preeclampsia diagnosed before 30 weeks gestation with overactive complement. As there is no effective treatment for preeclampsia other than delivery currently, women with preeclampsia before 30 weeks gestation are managed using a "watch and wait" approach (i.e., expectant management). Due to the unpredictable nature of preeclampsia, expectant management places mother and child at significant risk until delivery occurs. Eculizumab may be an improvement over current standard of care as it provides a treatment option for patients who would otherwise be managed with expectant management alone. If the study aims are achieved, eculizumab will emerge as an effective treatment option for women with preeclampsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm open label study.
| Arm | Type | Receives |
|---|---|---|
| Eculizumab | Experimental | Drug: EculizumabTwelve subjects in the interventional arm will receive eculizumab at an induction dose of 900mg IV weekly (q7 days) for 4 weeks followed by a dose of 1200mg IV at week 5. Thereafter, patients will receive a maintenance dose of 1200mg IV every two weeks (q14 days). The last dose of eculizumab will be given up to 48 hours post-partum, with a dose that is dependent on the dosing schedule (i.e. whether the last dose is given within the 4-week induction period or is during the maintenance phase). |
Who may qualify
- Ages
- 13 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures \& availability for study duration
- Biologically female, aged ≥13, body weight ≥40kg
- Diagnosed with preeclampsia between 23-29+6/7 weeks gestation, by following criteria:
- Ability to take intravenous medication and be willing to adhere to the eculizumab regimen
Key exclusion criteria (42 listed)
- An individual who meets any of the following criteria prior to enrollment will be excluded from participation in this study:
- Known allergic reactions eculizumab or meningococcal vaccine
- Febrile illness within prior 2 weeks
- Treatment with another investigational drug within previous 6 months
- Inpatient expectant management for preeclampsia >72 hours prior to enrollment
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 |
|---|---|---|
| EculizumabAlso: SolirisEculizumab Intravenous Solution | Drug | Eculizumab |
Primary outcome
Latency (in Days) From Enrollment to Delivery
Time frame: 24 months
The difference in mean number of days (latency) from enrollment in the study (or hospital admission for controls) to delivery between participant receiving eculizumab compared to historical controls. * For treatment-arm participants latency is determined from enrollment to delivery. * For historical controls latency is determined from hospital admission (or initial diagnosis for controls hospitalized for other indication) for preeclampsia until delivery. * Subjects and historical controls all defined as women with preeclampsia between 23-30 weeks gestation.
16 secondary outcomes
Composite Adverse Maternal Outcomes
Time frame: 24 months
Composite Adverse Neonatal Outcomes
Time frame: 24 months
Changes in Blood and Urine Concentrations of Terminal Complement Protein C5a Before and After Each Treatment.
Time frame: 24 months
Changes in Blood and Urine Concentrations of Terminal Complement Protein C5b-9 Before and After Each Treatment.
Time frame: 24 months
Changes in Blood and Urine Concentrations of Complement Protein CD59 Before and After Each Treatment.
Time frame: 24 months
Aspartate and Alanine Transaminase Concentration Before and After Each Treatment.
Time frame: 24 months
Hemoglobin Concentration Before and After Each Treatment.
Time frame: 24 months
Platelet Count Before and After Each Treatment.
Time frame: 24 months
Lactate Dehydrogenase Concentration Before and After Each Treatment.
Time frame: 24 months
Serum Creatinine Before and After Each Treatment.
Time frame: 24 months
Urine Protein Concentration Before and After Each Treatment.
Time frame: 24 months
Ratio of Urine Protein to Urine Creatinine Before and After Each Treatment.
Time frame: 24 months
Serum Concentration of Soluble Fms-like Tyrosine Kinase 1 (sFlt-1) Before and After Each Treatment.
Time frame: 24 months
Serum Concentration of Placental Growth Factor (PlGF) Before and After Each Treatment.
Time frame: 24 months
Serum Ratio of Soluble Fms-like Tyrosine Kinase 1 (sFlt-1) Concentration to Placental Growth Factor (PlGF) Concentration (sFlt-1/PlGF) Before and After Each Treatment.
Time frame: 24 months
Serious Adverse Events
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Preeclampsia
Not yet recruitingObservational study
Blood Pressure Goal in Preterm Preeclampsia
Hypertensive Disorder of Pregnancy, Preeclampsia
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
Usability Evaluation of Gen AI-based Nutrition Chatbot for Pregnant Women
Diabetes, Gestational, Pre-eclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
RecruitingPhase 2
Ravulizumab in Pregnancies Complicated by Severe Hypertensive Disorders
Preeclampsia
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.
Richard Burwick, MD, MPH principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eculizumab in people with Preeclampsia and Severe Preeclampsia, run by Cedars-Sinai Medical Center 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 9 inclusion and 42 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 29 Nov 2023. 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.
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 29 Nov 2023). 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?
Latency (in Days) From Enrollment to Delivery (time frame: 24 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 29 Nov 2023.