Blood SampleABBANCT07302880
The Acute Interference of Biotin in Blood Analysis
A study testing Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption in people with Blood Sample and Interference With Routine Analyical Tests, run by University of Copenhagen at 1 site in Denmark.
Trial summary
Biotin, also known as vitamin B7, is a water-soluble vitamin. It is essential for several metabolic processes in the body, including glucose, lipid, and protein metabolism, as it acts as a coenzyme in several carboxylation reactions. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Sample, Interference With Routine Analyical Tests, Biotin Ingestion
- What is being tested?
- Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 17 Mar 2026to 1 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 20-70 years of age at time of screening
- Body mass index of 18.6-25 kg/m2
Who cannot join
- Severe liver disease (estimated by FIB4 score > 3.25)
- Type 2 diabetes according to ADA criteria (estimated by HbA1c levels of ≥ 48 mmol/mol)
- Significant history of alcoholism or drug/chemical abuse as per investigators judgement
- Kidney disease defined as serum creatinine levels ≥ 126 μmol/L for male and ≥ 111 μmol/L for female or eGFR < 60 ml/min/1.73 m2
- Cardiac problems (defined as troponin T levels > 10 ng/L for woman and >19 ng/L for men) or including any of the following, based on medical history:
- Classified as being in New York Heart Association (NYHA) class III or IV
Show all 13Show fewer
- Angina pectoris (chest pain) within the last 6 months
- Acute myocardial infarction (heart attack) within last 2 years
- Cancer within the past 1 year
- Anemia (hemoglobin <8.3 mmol/L for men and <7.3 mmol/L for women)
- Pregnancy (requires negative pregnancy test) or breast feeding
- Smoking
- Any medicine, acute illness (within the last two weeks) or other circumstances that in the opinion of the investigator might endanger the participants' safety or compliance with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael M Richter contact
Denmark1 site, 1 recruiting
- Recruiting
Department of Clinical Biochemistry, Bispebjerg University Hospital, Copenhagen
Copenhagen
Nicolai J Wewer Albrechtsen, 21700880 ext. +45, nicolai.albrechtsen@regionh.dk
Michael M Richter, michael.martin.richter.02@regionh.dk
About this study
Biotin, also known as vitamin B7, is a water-soluble vitamin. It is essential for several metabolic processes in the body, including glucose, lipid, and protein metabolism, as it acts as a coenzyme in several carboxylation reactions. Biotin, available as an over the counter supplement, is widely used to improve nail and hair growth. The use of biotin supplements can interfere with various laboratory tests, due to the use of the streptavidin-biotin interaction in several immunoassays. The investigators therefore wish to assess the acute impact of biotin supplementation on various laboratory assays, with focus on the immediate post-ingestion effects and the time frame in which biotin interference is most pronounced.
Read the detailed description
Biotin, also known as vitamin B7, is a water-soluble vitamin. It is essential for several metabolic processes in the body, including glucose, lipid, and protein metabolism, as it acts as a coenzyme in several carboxylation reactions. Biotin, available as an over the counter supplement, is widely used to improve nail and hair growth. The use of biotin supplements can interfere with various laboratory tests, due to the use of the streptavidin-biotin interaction in several immunoassays. Therefore, if patients consume biotin supplements before blood tests, biotin may interfere with assays that rely on biotin-based analysis, especially in the first hours after biotin intake.
The investigators therefore wish to assess the acute impact of biotin supplementation on various laboratory assays, with focus on the immediate post-ingestion effects and the time frame in which biotin interference is most pronounced.
This study will provide data crucial for developing guidelines to manage and interpret test results for patients who have recently taken biotin supplements.
The primary aim of this study is to evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption.
The investigators hypothesize that biotin intake significantly affects the results of streptavidin-based laboratory assays for up to 5 hours after consumption, leading to inaccurate test results, and that the biotin interference subsides after 24 hours.
- Being tested
- Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption, Arm 1 - 10 mg → Placebo, Arm 2 - Placebo → 10 mg, Arm 3 - 100 mg → Placebo, Arm 4 - Placebo → 100 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumptionOther
The study will include two experimental days, each lasting 5 hours, as well as two short visits for a blood sample 24 hours after an experimental day.
The setup is as follows:
One study day with a single oral dose of biotin (randomized to either 10 mg or 100 mg), followed by a blood sample 24 hours after the study day with biotin.
One study day with a single oral dose of placebo, followed by a blood sample 24 hours after the study day with placebo.
The order of the two trials and the dose of biotin (either 10 mg or 100 mg) will also be randomized at inclusion.
During the study day, subjects will rest in a supine position and an intravenous catheter is inserted into the left or right antecubital vein for collecting blood samples. Following a blood sample, subjects will receive an oral dose either 10 mg or 100 mg biotin or placebo. In total, blood will be sampled 8 times over a period of 5 hours. After 24 hours, the subject will visit again for a single blood sample.
Arm 1 - 10 mg → PlaceboOther
Participants receive a 10 mg oral dose of biotin on the first study day and placebo on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.
Arm 2 - Placebo → 10 mgOther
Participants receive placebo on the first study day and a 10 mg oral dose of biotin on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.
Arm 3 - 100 mg → PlaceboOther
Participants receive a 100 mg oral dose of biotin on the first study day and placebo on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.
Arm 4 - Placebo → 100 mgOther
Intervention: Participants receive placebo on the first study day and a 100 mg oral dose of biotin on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (Cohort A): 10 mg of biotin versus placebo | Experimental | Arm 1: 10 mg biotin → placebo (n = 6) Receives: Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption; Other: Arm 1 - 10 mg → Placebo |
| Arm 2 (Cohort A): 10 mg of biotin versus placebo | Experimental | Arm 2: placebo → 10 mg biotin (n = 6) Receives: Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption; Other: Arm 2 - Placebo → 10 mg |
| Arm 3 (Cohort B): 100 mg of biotin versus placebo | Experimental | Arm 3: 100 mg biotin → placebo (n = 6) Receives: Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption; Other: Arm 3 - 100 mg → Placebo |
| Arm 4 (Cohort B): 100 mg of biotin versus placebo | Experimental | Arm 4: placebo → 100 mg biotin (n = 6) Receives: Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption; Other: Arm 4 - Placebo → 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t=120 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with placebo).
Measured: Blood sample on study day at timepoint = 120 minutes.
Secondary outcomes (6)
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t=30, 60, 90, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with placebo).
Measured: Blood sample on study day at timepoint = 30, 60, 90, 180, 240, 300 minutes
The effect of 10 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
The effect of 10 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t= 30, 60, 90, 120, 180, 240 and 300, calculated as the fold change between study day with biotin (10mg biotin) and study day with placebo.)
Measured: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus 100 mg biotin on plasma levels of thyroid peroxidase antibody (TPOAb)
The effect of 10 mg of biotin versus 100 mg biotin on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with biotin (10 mg biotin).
Measured: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 100 mg of biotin versus placebo on plasma levels of secondary outcomes
The effect of 100 mg of biotin versus placebo on plasma levels of secondary outcomes, including among others insulin, TSH, TnT, C-peptide, ProBNP (defined as the difference in peak concentration levels at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with placebo).
Measured: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus placebo on plasma levels of secondary outcomes
The effect of 10 mg of biotin versus placebo on plasma levels of secondary outcomes, including among others insulin, TSH, TnT, C-peptide, ProBNP (defined as the difference in peak concentration levels at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (10 mg biotin) and study day with placebo).
Measured: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus 100 mg on plasma levels of secondary outcomes
The effect of 10 mg of biotin versus 100 mg on plasma levels of secondary outcomes, including among others insulin, TSH, TnT, C-peptide, ProBNP (defined as the difference in peak concentration levels at t=30, 60, 90, 120, 180, 240 and 300 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with biotin (10 mg).
Measured: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start17 Mar 2026
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood SampleStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Nicolai Jacob Wewer Albrechtsen, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302880
- Sponsor's protocol ID
- ABBA
- Acronym
- ABBA
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have not decided to share IPD as this also would require approval from the ethical and data approval committee.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Interference of Biotin in Blood Analysis
- ClinicalTrials.gov ID
- NCT07302880
- Acronym / sponsor ID
- ABBA / ABBA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- 17 Mar 2026 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 24 Dec 2025 (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.
Biotin, also known as vitamin B7, is a water-soluble vitamin. It is essential for several metabolic processes in the body, including glucose, lipid, and protein metabolism, as it acts as a coenzyme in several carboxylation reactions. Biotin, available as an over the counter supplement, is widely used to improve nail and hair growth. The use of biotin supplements can interfere with various laboratory tests, due to the use of the streptavidin-biotin interaction in several immunoassays. The investigators therefore wish to assess the acute impact of biotin supplementation on various laboratory assays, with focus on the immediate post-ingestion effects and the time frame in which biotin interference is most pronounced.
Detailed description
Biotin, also known as vitamin B7, is a water-soluble vitamin. It is essential for several metabolic processes in the body, including glucose, lipid, and protein metabolism, as it acts as a coenzyme in several carboxylation reactions. Biotin, available as an over the counter supplement, is widely used to improve nail and hair growth. The use of biotin supplements can interfere with various laboratory tests, due to the use of the streptavidin-biotin interaction in several immunoassays. Therefore, if patients consume biotin supplements before blood tests, biotin may interfere with assays that rely on biotin-based analysis, especially in the first hours after biotin intake.
The investigators therefore wish to assess the acute impact of biotin supplementation on various laboratory assays, with focus on the immediate post-ingestion effects and the time frame in which biotin interference is most pronounced.
This study will provide data crucial for developing guidelines to manage and interpret test results for patients who have recently taken biotin supplements.
The primary aim of this study is to evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption.
The investigators hypothesize that biotin intake significantly affects the results of streptavidin-based laboratory assays for up to 5 hours after consumption, leading to inaccurate test results, and that the biotin interference subsides after 24 hours.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blinded, placebo-controlled, cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (Cohort A): 10 mg of biotin versus placebo | Experimental | Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption, Other: Arm 1 - 10 mg → PlaceboArm 1: 10 mg biotin → placebo (n = 6) |
| Arm 2 (Cohort A): 10 mg of biotin versus placebo | Experimental | Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption, Other: Arm 2 - Placebo → 10 mgArm 2: placebo → 10 mg biotin (n = 6) |
| Arm 3 (Cohort B): 100 mg of biotin versus placebo | Experimental | Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption, Other: Arm 3 - 100 mg → PlaceboArm 3: 100 mg biotin → placebo (n = 6) |
| Arm 4 (Cohort B): 100 mg of biotin versus placebo | Experimental | Other: Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption, Other: Arm 4 - Placebo → 100 mgArm 4: placebo → 100 mg biotin (n = 6) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female between 20-70 years of age at time of screening
- Body mass index of 18.6-25 kg/m2
Key exclusion criteria (13 listed)
- Severe liver disease (estimated by FIB4 score > 3.25)
- Type 2 diabetes according to ADA criteria (estimated by HbA1c levels of ≥ 48 mmol/mol)
- Significant history of alcoholism or drug/chemical abuse as per investigators judgement
- Kidney disease defined as serum creatinine levels ≥ 126 μmol/L for male and ≥ 111 μmol/L for female or eGFR < 60 ml/min/1.73 m2
- Cardiac problems (defined as troponin T levels > 10 ng/L for woman and >19 ng/L for men) or including any of the following, based on medical history:
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 |
|---|---|---|
| Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumptionThe study will include two experimental days, each lasting 5 hours, as well as two short visits for a blood sample 24 hours after an experimental day. The setup is as follows: One study day with a single oral dose of biotin (randomized to either 10 mg or 100 mg), followed by a blood sample 24 hours after the study day with biotin. One study day with a single oral dose of placebo, followed by a blood sample 24 hours after the study day with placebo. The order of the two trials and the dose of biotin (either 10 mg or 100 mg) will also be randomized at inclusion. During the study day, subjects will rest in a supine position and an intravenous catheter is inserted into the left or right antecubital vein for collecting blood samples. Following a blood sample, subjects will receive an oral dose either 10 mg or 100 mg biotin or placebo. In total, blood will be sampled 8 times over a period of 5 hours. After 24 hours, the subject will visit again for a single blood sample. | Other | Arm 1 (Cohort A): 10 mg of biotin versus placebo, Arm 2 (Cohort A): 10 mg of biotin versus placebo, Arm 3 (Cohort B): 100 mg of biotin versus placebo, Arm 4 (Cohort B): 100 mg of biotin versus placebo |
| Arm 1 - 10 mg → PlaceboParticipants receive a 10 mg oral dose of biotin on the first study day and placebo on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later. | Other | Arm 1 (Cohort A): 10 mg of biotin versus placebo |
| Arm 2 - Placebo → 10 mgParticipants receive placebo on the first study day and a 10 mg oral dose of biotin on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later. | Other | Arm 2 (Cohort A): 10 mg of biotin versus placebo |
| Arm 3 - 100 mg → PlaceboParticipants receive a 100 mg oral dose of biotin on the first study day and placebo on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later. | Other | Arm 3 (Cohort B): 100 mg of biotin versus placebo |
| Arm 4 - Placebo → 100 mgIntervention: Participants receive placebo on the first study day and a 100 mg oral dose of biotin on the second study day. Blood samples are collected over 5 hours on each visit, with an additional fasting sample 24 hours later. | Other | Arm 4 (Cohort B): 100 mg of biotin versus placebo |
Primary outcome
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
Time frame: Blood sample on study day at timepoint = 120 minutes.
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (defined as the difference in peak concentration level of TPOAb at t=120 minutes, calculated as the fold change between study day with biotin (100 mg biotin) and study day with placebo).
6 secondary outcomes
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 180, 240, 300 minutes
The effect of 10 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb)
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus 100 mg biotin on plasma levels of thyroid peroxidase antibody (TPOAb)
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 100 mg of biotin versus placebo on plasma levels of secondary outcomes
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus placebo on plasma levels of secondary outcomes
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
The effect of 10 mg of biotin versus 100 mg on plasma levels of secondary outcomes
Time frame: Blood sample on study day at timepoint = 30, 60, 90, 120, 180, 240, 300 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. We have not decided to share IPD as this also would require approval from the ethical and data approval committee.
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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.
Michael M Richter contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overall: To evaluate the acute effect of biotin intake on streptavidin-based laboratory assays during the hours immediately following consumption in people with Blood Sample and Interference With Routine Analyical Tests, run by University of Copenhagen at 1 site in Denmark.
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 2 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolai J Wewer Albrechtsen (21700880 ext. 45, nicolai.albrechtsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of 100 mg of biotin versus placebo on plasma levels of thyroid peroxidase antibody (TPOAb) (time frame: Blood sample on study day at timepoint = 120 minutes.). 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 6 May 2026.