Asymptomatic HyperuricemiaPhase 1NCT05302388
A Study Exploring Efficacy of Pegloticase in Subjects With Asymptomatic Hyperuricemia
A Phase 1 study testing SIBP-R002, Dexamethasone or Methyl prednisolone and Diphenhydramine in people with Asymptomatic Hyperuricemia, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
The main purpose To evaluate the safety and tolerability of pegloticase in subjects with asymptomatic hyperuricemia by single intravenous infusion at different doses, and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asymptomatic Hyperuricemia
- What is being tested?
- SIBP-R002, Dexamethasone or Methyl prednisolone and Diphenhydramine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 11 Apr 2022to 9 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subjects voluntarily participated in the study and signed the informed consent.
- Male and female aged between 18 and 65 years old , regardless of gender.
- Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg/m2 (including 19 and 30), and no central obesity (waist circumference <90 cm for men, waist circumference <85 cm for women);
- Patients diagnosed as "hyperuricemia" according to The Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019), namely, patients whose blood uric acid level exceeds 480 μmol/L twice on other days, and no clinical symptoms related to hyperuricemia such as arthritis;
- Agree to use effective contraceptive methods (including but not limited to abstinence, physical or hormonal contraception, but not hormonal contraception during the study) from signing the informed consent form until 6 months after the infusion of the study drug;
- The subjects can attend the interview on time and complete the interview content.
Who cannot join
- People who have a history of gout and are using or have used other medications to control uric acid levels in the last 3 months, Asymptomatic hyperuricemia patients who stopped taking uricate-lowering drugs for more than 3 months were excluded.
- Secondary hyperuricemia (such as kidney disease, blood system disease, tumor chemotherapy or drug induced).
- Urolithiasis, or renal, ureteral calculi, urate crystal deposition indicated by ultrasound during screening; The presence of tophi or joint/bursa involvement was indicated by junction ultrasonography.
- Autoimmune disease, allergic disease, prior known food or drug allergy.
- Allergic reactions to recombinant proteins or pig products, or to uricase, polyethylene glycol, corticosteroids and antihistamines.
- Patients who have previously been treated with pegyluricase or other recombinant uricase, or who have been treated with other pegylated biological products.
Show all 18Show fewer
- Patients have unstable angina, severe arrhythmias requiring drug intervention, congestive heart failure (NYHA grade≥Ⅱ), uncontrolled hypertension (over 150/95 mmHg), poor glycemic control in diabetics ( HbA1c≥7%), end-stage renal disease (CKD4-5), acute stroke, chest imaging suggesting active or severe lung disease, requiring dialysis, organ transplant recipients, and patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- Serum creatinine was 1.5 times higher than the upper limit of normal value, and serum transaminase baseline level was 1.5 times higher than the upper limit of normal value.
- Hepatitis B surface antigen positive, hepatitis C antibody positive, treponema pallidum antibody positive or HIV antibody positive in serum virology examination.
- Patients who have been treated with any other investigational drug or participated in another interventional clinical trial within 3 months prior to screening.
- Patients complicated with malignant tumor or undergoing anti-tumor therapy.
- Patients have serious mental and psychological disorders, cognitive disorders and the existence of a history of mental illness.
- Patients have been alcohol abuse within 3 months prior to screening (drinking more than 14 units of alcohol per week (1 unit ≈360 mL beer or 45 mL 40% spirits or 150 mL wine)); Alcohol breath test positive at screening or admission.
- Patients who smoked more than 5 cigarettes a day during the 3 months prior to the study and were unwilling to stop smoking during the study period.
- Patients had been excessive drinking of tea , coffee or caffeinated beverages for a long time (more than 8 cups per day, 1 cup =250 mL); Or any food or beverage containing caffeine or xanthine (such as coffee, strong tea, chocolate, etc.) within 48 hours prior to initial administration.
- Patients have a history of drug or substance abuse, or a positive drug screening test.
- Women who are pregnant or breast-feeding or who plan to become pregnant or breast-feeding during the study period, or who have a positive pregnancy test at the screening stage or baseline.
- The investigator considers that the patient has any other medical or psychological conditions that may pose an undue risk to the subject or interfere with the subject's ability to comply with study protocol requirements or complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of Bengbu medical college
Bengbu, Anhui
About this study
Official title: A Phase I Randomized, Double-blind, Placebo-controlled, Dose-increasing Single Dose Study Evaluating the Safety, Tolerability，Pharmacokinetics and Pharmacodynamics Analysis of Pegloticase in Subjects With Asymptomatic Hyperuricemia
The main purpose To evaluate the safety and tolerability of pegloticase in subjects with asymptomatic hyperuricemia by single intravenous infusion at different doses, and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia.
A secondary purpose To evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of Pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia.
Exploratory purpose Plasma uricase activity (pUox) analysis of pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia.
Read the detailed description
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics analysis of pegloticase in subjects with asymptomatic hyperuricemia.
This is a phase I randomized, double-blind, placebo-controlled and dose-increasing single dosing study. Five dose groups of 1, 2, 4, 8 or 12 mg were planned to explore the most appropriate dose and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia.
- Conditions
- Asymptomatic Hyperuricemia
- Being tested
- SIBP-R002, Dexamethasone or Methyl prednisolone, Diphenhydramine, Placebo
- Keywords
- Hyperuricemia, Pegloticase, Safety, Tolerability
- Medical subject headings
- Hyperuricemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIBP-R002Drug
SIBP-R002: injection; strength: 1, 2, 4, 8 or 12 mg; dose escalation and the first group is 1mg (intravenous infusion, 5 groups, the first group consisted of four people, and the other groups consisted of eight).
Dexamethasone or Methyl prednisoloneDrug
Intravenous infusion, 5mg or 1~2mg/kg. These were administered within 30 minutes prior to infusion of the experimental drug.
DiphenhydramineDrug
10mg, intramuscular injection.These were administered within 30 minutes prior to infusion of the experimental drug.
PlaceboDrug
The same volume of placebo as SIBP-R002: injection; strength: the same volume of placebo as SIBP-R002 of 1, 2, 4, 8 or 12 mg (intravenous infusion, 5 groups, the first group consisted of one people, and the other groups consisted of two). The rule and dose of placebo were the same as SIBP-R002.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Drug: SIBP-R002 \& Dexamethasone/Methyl prednisolone \& Diphenhydramine Starting from the lowest dose, when the former dose does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). Receives: Drug: SIBP-R002; Drug: Dexamethasone or Methyl prednisolone; Drug: Diphenhydramine |
| Placebo control group | Placebo comparator | Placebo control: The same volume of placebo as SIBP-R002 \& Dexamethasone/Methyl prednisolone \& Diphenhydramine The rule and dose of placebo were the same as SIBP-R002. Receives: Drug: Dexamethasone or Methyl prednisolone; Drug: Diphenhydramine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of any adverse events (AE)
All subjects were observed during the trial for any AE that occurred during the clinical study, including clinical symptoms and life abnormal physical signs, abnormalities in electrocardiogram and laboratory tests. Attention should be paid to the occurrence of AE related to infusion reaction, allergic reaction, vomiting and watery stools/loose stools, acute attack of gout, cardiovascular adverse events and so on.
Measured: 35 days after the last dose
The number of serious adverse events (SAE)
That is serious adverse events, any serious adverse events that occurred to the subject during the study period.
Measured: 35 days after the last dose
Secondary outcomes (16)
AUC 0-t (Area Under The Plasma Concentration Versus Time Curve)
Area under the blood concentration-time curve from 0 to T. It shows the degree to which a drug is absorbed and used in the body.
Measured: 35 days after the last dose
Cmax(Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Measured: 35 days after the last dose
AUC inf (Area Under The Plasma Concentration Versus Time Curve)
Area under the blood concentration-time curve from 0 to unlimited time. It shows the degree to which a drug is absorbed and used in the body.
Measured: 35 days after the last dose
Tmax(Peak Time)
That is peak time of drug action, it shows the time required to reach the maximum concentration on the subject plasma concentration curve after administration.
Measured: 35 days after the last dose
T ½(Terminal elimination half-life)
It reflects how quickly the drug is eliminated from the body.
Measured: 35 days after the last dose
CL(Clearance Rate)
Apparent volume of drug distribution removed from the body per unit time.
Measured: 35 days after the last dose
The uric acid to creatinine ratio in Urine
To evaluate the effect of single use of peruricase on uric acid to creatinine ratio (UAc:Cr) in 24h urine of patients with hyperuricemia.
Measured: 35 days after the last dose
Vd(Apparent volume of distribution)
Apparent volume of distribution refers to the ratio of the amount of drug in vivo to the concentration of drug in blood when a drug reaches dynamic equilibrium in the body. It is a widely used parameters for drug distribution.
Measured: 35 days after the last dose
λz
Elimination rate constant of a drug.It is a common pharmacokinetic indicator.
Measured: 35 days after the last dose
The positive rate of anti-uricase antibody
An evaluation index of immunogenicity of an experimental drug. If detected, it is positive.
Measured: 35 days after the last dose
The positive rate of anti-PEG antibody
An evaluation index of immunogenicity of an experimental drug. If detected, it is positive.
Measured: 35 days after the last dose
The positive rate of anti-PEG-uricase antibody
An evaluation index of immunogenicity of an experimental drug. If detected, it is positive.
Measured: 35 days after the last dose
Antibody titer of anti-uricase antibody
An evaluation index of immunogenicity of an experimental drug.
Measured: 35 days after the last dose
Antibody titer of anti-PEG Antibody
An evaluation index of immunogenicity of an experimental drug.
Measured: 35 days after the last dose
Antibody titer of anti-PEG-uricase Antibody
An evaluation index of immunogenicity of an experimental drug.
Measured: 35 days after the last dose
Positive rate of neutralizing antibody(NAb)
NAb positive rate was assessed by detecting neutralizing antibodies in blood samples.
Measured: 35 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start11 Apr 2022
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asymptomatic HyperuricemiaStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a phase I randomized, double-blind, placebo-controlled and dose-increasing single dosing study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Responsible party
- Sponsor
- Investigators
- The First Affiliated Hospital of Bengbu Medical College The First Affiliated Hospital of Bengbu Medical College, Master, Study director, Shanghai Institute Of Biological ProductsHuan Zhou, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302388
- Sponsor's protocol ID
- SIBP-R002
- Status last verified
- Dec 2023
- First submitted
- 19 Mar 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-blind, Placebo-controlled, Dose-increasing Single Dose Study Evaluating the Safety, Tolerability，Pharmacokinetics and Pharmacodynamics Analysis of Pegloticase in Subjects With Asymptomatic Hyperuricemia
- ClinicalTrials.gov ID
- NCT05302388
- Acronym / sponsor ID
- SIBP-R002
- Conditions
- Asymptomatic Hyperuricemia
- Keywords
- Hyperuricemia, Pegloticase, Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Bengbu Medical University
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 31 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.
The main purpose To evaluate the safety and tolerability of pegloticase in subjects with asymptomatic hyperuricemia by single intravenous infusion at different doses, and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia.
A secondary purpose To evaluate the pharmacokinetics, pharmacodynamics and immunogenicity of Pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia.
Exploratory purpose Plasma uricase activity (pUox) analysis of pegloticase with single-pass intravenous drip in subjects with asymptomatic hyperuricemia.
Detailed description
To evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics analysis of pegloticase in subjects with asymptomatic hyperuricemia.
This is a phase I randomized, double-blind, placebo-controlled and dose-increasing single dosing study. Five dose groups of 1, 2, 4, 8 or 12 mg were planned to explore the most appropriate dose and to provide a basis for multiple doses of Pegloticase in subjects with asymptomatic hyperuricemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a phase I randomized, double-blind, placebo-controlled and dose-increasing single dosing study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: SIBP-R002, Drug: Dexamethasone or Methyl prednisolone, Drug: DiphenhydramineDrug: SIBP-R002 \& Dexamethasone/Methyl prednisolone \& Diphenhydramine Starting from the lowest dose, when the former dose does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). |
| Placebo control group | Placebo comparator | Drug: Dexamethasone or Methyl prednisolone, Drug: Diphenhydramine, Drug: PlaceboPlacebo control: The same volume of placebo as SIBP-R002 \& Dexamethasone/Methyl prednisolone \& Diphenhydramine The rule and dose of placebo were the same as SIBP-R002. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subjects voluntarily participated in the study and signed the informed consent.
- Male and female aged between 18 and 65 years old , regardless of gender.
- Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg/m2 (including 19 and 30), and no central obesity (waist circumference <90 cm for men, waist circumference <85 cm for women);
- Patients diagnosed as "hyperuricemia" according to The Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019), namely, patients whose blood uric acid level exceeds 480 μmol/L twice on other days, and no clinical symptoms related to hyperuricemia such as arthritis;
- Agree to use effective contraceptive methods (including but not limited to abstinence, physical or hormonal contraception, but not hormonal contraception during the study) from signing the informed consent form until 6 months after the infusion of the study drug;
Key exclusion criteria (18 listed)
- People who have a history of gout and are using or have used other medications to control uric acid levels in the last 3 months, Asymptomatic hyperuricemia patients who stopped taking uricate-lowering drugs for more than 3 months were excluded.
- Secondary hyperuricemia (such as kidney disease, blood system disease, tumor chemotherapy or drug induced).
- Urolithiasis, or renal, ureteral calculi, urate crystal deposition indicated by ultrasound during screening; The presence of tophi or joint/bursa involvement was indicated by junction ultrasonography.
- Autoimmune disease, allergic disease, prior known food or drug allergy.
- Allergic reactions to recombinant proteins or pig products, or to uricase, polyethylene glycol, corticosteroids and antihistamines.
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 |
|---|---|---|
| SIBP-R002SIBP-R002: injection; strength: 1, 2, 4, 8 or 12 mg; dose escalation and the first group is 1mg (intravenous infusion, 5 groups, the first group consisted of four people, and the other groups consisted of eight). | Drug | Experimental group |
| Dexamethasone or Methyl prednisoloneIntravenous infusion, 5mg or 1~2mg/kg. These were administered within 30 minutes prior to infusion of the experimental drug. | Drug | Experimental group, Placebo control group |
| Diphenhydramine10mg, intramuscular injection.These were administered within 30 minutes prior to infusion of the experimental drug. | Drug | Experimental group, Placebo control group |
| PlaceboThe same volume of placebo as SIBP-R002: injection; strength: the same volume of placebo as SIBP-R002 of 1, 2, 4, 8 or 12 mg (intravenous infusion, 5 groups, the first group consisted of one people, and the other groups consisted of two). The rule and dose of placebo were the same as SIBP-R002. | Drug | Placebo control group |
Primary outcome
The number of any adverse events (AE)
Time frame: 35 days after the last dose
All subjects were observed during the trial for any AE that occurred during the clinical study, including clinical symptoms and life abnormal physical signs, abnormalities in electrocardiogram and laboratory tests. Attention should be paid to the occurrence of AE related to infusion reaction, allergic reaction, vomiting and watery stools/loose stools, acute attack of gout, cardiovascular adverse events and so on.
The number of serious adverse events (SAE)
Time frame: 35 days after the last dose
That is serious adverse events, any serious adverse events that occurred to the subject during the study period.
16 secondary outcomes
AUC 0-t (Area Under The Plasma Concentration Versus Time Curve)
Time frame: 35 days after the last dose
Cmax(Peak Plasma Concentration)
Time frame: 35 days after the last dose
AUC inf (Area Under The Plasma Concentration Versus Time Curve)
Time frame: 35 days after the last dose
Tmax(Peak Time)
Time frame: 35 days after the last dose
T ½(Terminal elimination half-life)
Time frame: 35 days after the last dose
CL(Clearance Rate)
Time frame: 35 days after the last dose
The uric acid to creatinine ratio in Urine
Time frame: 35 days after the last dose
Vd(Apparent volume of distribution)
Time frame: 35 days after the last dose
λz
Time frame: 35 days after the last dose
The positive rate of anti-uricase antibody
Time frame: 35 days after the last dose
The positive rate of anti-PEG antibody
Time frame: 35 days after the last dose
The positive rate of anti-PEG-uricase antibody
Time frame: 35 days after the last dose
Antibody titer of anti-uricase antibody
Time frame: 35 days after the last dose
Antibody titer of anti-PEG Antibody
Time frame: 35 days after the last dose
Antibody titer of anti-PEG-uricase Antibody
Time frame: 35 days after the last dose
Positive rate of neutralizing antibody(NAb)
Time frame: 35 days after the last dose
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 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Asymptomatic Hyperuricemia
Active, not recruitingPhase 1
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
Healthy Volunteers, Hyperuricemia
Recruiting
Tart Cherry Citrate Effervescent Tablet for Urate-Lowering Therapy in Participants With Asymptomatic Hyperuricemia
Hyperuricemia With or Without Gout
Not yet recruiting
Study on the Effects and Mechanisms of Probiotic Supplementation in Ameliorating Uric Acid Metabolism in Asymptomatic Hyperuricemic Individuals
Asymptomatic Hyperuricemia
Active, not recruiting
Imagery as Biomarker of Gout
Hyperuricemia
Recruiting
Clinical Efficacy Trial of Burdock Root Extract in Patients With Asymptomatic Hyperuricaemia
Hyperuricemia or Gout
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.
The First Affiliated Hospital of Bengbu Medical College The First Affiliated Hospital of Bengbu Medical College, Master study director
Shanghai Institute Of Biological Products
Huan Zhou principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SIBP-R002, Dexamethasone or Methyl prednisolone and Diphenhydramine in people with Asymptomatic Hyperuricemia, run by Shanghai Institute Of Biological Products at 1 site in China.
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 6 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: finished, as of the sponsor's last update on 27 Dec 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 China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study 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?
The number of any adverse events (AE) (time frame: 35 days after the last dose). The study lists 2 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 27 Dec 2023.