HealthyPhase 1NCT03535571
A Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
A Phase 1 study testing Salmon Protein Hydrolysate in people with Healthy, run by Hofseth Biocare ASA at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder (CollaGo®) on energy increase and anti-inflammatory modulation in healthy males and females. Eligible participants will be asked to consume 1 sachet of CollaGo for 128 days and keep a study diary. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Salmon Protein Hydrolysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 5 Jun 2018to 23 Oct 2018
- Phase
- Phase 1
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, 30-60 years of age
- Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) or,
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
Show all 14Show fewer
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner (shown successful as per appropriate follow-up)
- BMI of 18.5 kg/m²-32.5 kg/m²
- Agrees to comply with study procedures
- Willing to commit to taking product for 128 days
- Agrees to provide voluntary, written, informed consent to participate in the study
- Agrees to maintain normal diet and exercise routine throughout the study
- Healthy as determined by medical history, medical physical test for good health, and laboratory results
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Blood donation during or within 30 days of the last study visit
- Taking any specific energy supplements or vitamins at least 1 month prior to and during the trial as assessed by the QI
- Unstable weight for the last 2 months prior to the study assessed case by case by QI
- Individuals on a low protein diet
- Excessive consumption of alcohol equivalent to >2 alcoholic drinks/day
Show all 29Show fewer
- Use of marijuana assessed case by case by QI
- Known allergy to the test material's active or inactive ingredients
- Clinically significant abnormal Physical Examination results at screening
- Participation in clinical trials in the past 30 days
- Cognitively impaired and/or unable to give informed consent
- current cardiovascular disorders or uncontrolled blood pressure will be assessed by QI)
- Verbal confirmation of history of or current diagnosis of bleeding/blood disorder
- Verbal confirmation of Type I or Type II diabetes
- Verbal confirmation of kidney disease
- Verbal confirmation of history of liver disease
- Anemia based on hemoglobin and hematocrit at screening
- Thyroid disease assessed case by case by QI
- Iron Supplementation
- Mood stabilizers assessed case by case by QI
- Energy boosting supplements
- Individuals on workout supplements
- Habitual users of energy drinks
- Melatonin supplementation assessed case by case by QI
- Autoimmune disease or if immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive)
- Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
- Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission will be assessed by the QI for inclusion.
- Presence or history of neurological disorders or significant psychiatric illness as assessed by QI
- Any other condition, in the QI's opinion, which may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-concept Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder (CollaGo®) on energy increase and anti-inflammatory modulation in healthy males and females. Eligible participants will be asked to consume 1 sachet of CollaGo for 128 days and keep a study diary. Assessments will be measured at the randomization visit, and the end of study visit.
- Conditions
- Healthy
- Being tested
- Salmon Protein Hydrolysate
- Keywords
- Energy increase, Energy, Healthy, anti-inflammatory, Open-label, Salmon protein, Natural health product, Dietary supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmon Protein HydrolysateDietary supplement
Also called CollaGo®
4g of salmon protein hydrolysate per serving.
| Study group | Role | What they receive |
|---|---|---|
| Salmon Protein Hydrolysate (CollaGo®) | Experimental | Dose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. Receives: Dietary Supplement: Salmon Protein Hydrolysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change From Baseline (Day 0) to End-of-study (Day 128) in Energy Level After a 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
This questionnaire consists of a total of 30 questions that assess vitality and quality of life. The responses for these questions range from 1 to 7, where 1 indicates "never" or "not at all true" 4 indicates "sometimes" or "somewhat true" and 7 indicates "always" or "very true" depending on the item that is assessed by the question.
15 of the 30 questions are positively keyed in which a higher score indicates a better outcome and remaining 15 questions are negatively keyed where a lower score indicates a better outcome. The responses on the negatively keyed questions will be reversed prior to calculating the total score (i.e. a response of 1 will be considered as 7, 2 will be considered as 6, etc.). Total range will be 30-210, where a higher total score indicates a better outcome and a lower total score indicates a worse outcome.
Measured: Baseline (Day 0) to end-of-study (Day 128)
Secondary outcomes (19)
Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Evaluated by oxidative stress-related gene RT Profiler PCR array. Seven of the 84 genes were upregulated, which are highlighted in the results.
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Total Reactive Oxygen Species/Reactive Nitrogen Species Free Radical Activity After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Assessed by ROS/RNS assay
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Measured by the Multi-Analyte ELISArray
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Measured by the Multi-Analyte ELISArray
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Measured by the Multi-Analyte ELISArray
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Measured by the Multi-Analyte ELISArray
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-11 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Measured by the Multi-Analyte ELISArray.
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Measured by the Multi-Analyte ELISArray
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine TGF-Beta After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured by the Multi-Analyte ELISArray
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Measured: Baseline (Day 0) to end-of-study (Day 128)
Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
This questionnaire consists of a total of 7 questions that assess the participant's perception on hair (4 questions), nail (1 question) and skin health (2 question). The response to each question can range from 1 to 6 where 1 indicates "greatly satisfied" and 6 indicates "greatly dissatisfied".
The range for the total score on this questionnaire is 7-42. Lower total score indicates a better outcome, and higher total score indicates a worse outcome.
Measured: Baseline (Day 0) to end-of-study (Day 128)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start5 Jun 2018
- Primary completion23 Oct 2018
- Study completion23 Oct 2018
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 HealthyStudies 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 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535571
- Sponsor's protocol ID
- 18PEHH
- Status last verified
- Jul 2019
- First submitted
- 14 May 2018
- Last updated
- 19 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Study to Evaluate the Efficacy of Salmon Protein Hydrolysate Powder on Energy Increase and Anti-inflammatory Modulation in Healthy Males and Females
- ClinicalTrials.gov ID
- NCT03535571
- Acronym / sponsor ID
- 18PEHH
- Conditions
- Healthy
- Keywords
- Energy increase, Energy, Healthy, anti-inflammatory, Open-label, Salmon protein, Natural health product, Dietary supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 23 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 24 May 2018 (actual)
- Results
- Posted 19 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the efficacy of Salmon Protein Hydrolysate Powder (CollaGo®) on energy increase and anti-inflammatory modulation in healthy males and females. Eligible participants will be asked to consume 1 sachet of CollaGo for 128 days and keep a study diary. Assessments will be measured at the randomization visit, and the end of study visit.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Salmon Protein Hydrolysate (CollaGo®) | Experimental | Dietary Supplement: Salmon Protein HydrolysateDose: 1 sachet of CollaGo® will be mixed with 100-300 mL of water and consumed daily at breakfast. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male or female, 30-60 years of age
- Female participant is not of child bearing potential, defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) or,
- Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- BMI of 18.5 kg/m²-32.5 kg/m²
- Agrees to comply with study procedures
Key exclusion criteria (29 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Blood donation during or within 30 days of the last study visit
- Taking any specific energy supplements or vitamins at least 1 month prior to and during the trial as assessed by the QI
- Unstable weight for the last 2 months prior to the study assessed case by case by QI
- Individuals on a low protein diet
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 |
|---|---|---|
| Salmon Protein HydrolysateAlso: CollaGo®4g of salmon protein hydrolysate per serving. | Dietary supplement | Salmon Protein Hydrolysate (CollaGo®) |
Primary outcome
The Change From Baseline (Day 0) to End-of-study (Day 128) in Energy Level After a 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
This questionnaire consists of a total of 30 questions that assess vitality and quality of life. The responses for these questions range from 1 to 7, where 1 indicates "never" or "not at all true" 4 indicates "sometimes" or "somewhat true" and 7 indicates "always" or "very true" depending on the item that is assessed by the question. 15 of the 30 questions are positively keyed in which a higher score indicates a better outcome and remaining 15 questions are negatively keyed where a lower score indicates a better outcome. The responses on the negatively keyed questions will be reversed prior to calculating the total score (i.e. a response of 1 will be considered as 7, 2 will be considered as 6, etc.). Total range will be 30-210, where a higher total score indicates a better outcome and a lower total score indicates a worse outcome.
19 secondary outcomes
Change From Baseline to Day 128 in Red Blood Cell (RBC) Count After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Mean Corpuscular Volume (MCV) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin (MCH) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Mean Corpuscular Hemoglobin Concentration (MCHC) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Hematocrit After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Red Cell Distribution Width (RDW) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Hemoglobin (Hb) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Relative Expression of 84 Stress Genes After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Total Reactive Oxygen Species/Reactive Nitrogen Species Free Radical Activity After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-1 Alpha After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-4 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-6 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-10 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-11 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine IL-13 After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®).
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Levels of Human Inflammatory Cytokine TGF-Beta After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Glycated Hemoglobin (HbA1c) After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change From Baseline to Day 128 in Fasting Glucose After Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Change in Score of the Hair, Nails, and Skin Self-Assessment Questionnaire After 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®)
Time frame: Baseline (Day 0) to end-of-study (Day 128)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Crowley, MD principal investigator
KGK Science Inc.
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 Salmon Protein Hydrolysate in people with Healthy, run by Hofseth Biocare ASA at 1 site in Canada.
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 29 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 19 Aug 2019. 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 Canada. 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 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?
Yes. Results are posted in the registry (first posted 19 Aug 2019). 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?
The Change From Baseline (Day 0) to End-of-study (Day 128) in Energy Level After a 128-day Supplementation With Collagenic Salmon Protein Hydrolysate Powder (CollaGo®) (time frame: Baseline (Day 0) to end-of-study (Day 128)). 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 19 Aug 2019.