DermatomyositisPhase 3NCT03686969
Study Evaluating Efficacy and Safety of Octanorm in Patients With Dermatomyositis
A Phase 3 study testing Octanorm in people with Dermatomyositis, run by Octapharma at 1 site in Russia.
Trial summary
DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dermatomyositis
- What is being tested?
- Octanorm
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteRussia
- Study dates
- 2 Aug 2018to 29 Nov 2018
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with diagnosis of definite or probable DM according to the Bohan and Peter criteria.
- Subjects who have responded to IGIV treatment as assessed by the treating physician and being on a stable dose for at least 3 months on 2 g/kg bodyweight (+/- 10%).
- For subjects being on other medication(s) for the treatment of DM (immunosuppressants, corticosteroids): a) subject was on such medication(s) at the start of IGIV treatment in the first place, and b) received such medication(s) for at least 3 months prior to study enrolment and at a stable dose for at least 4 weeks prior to study enrolment at the maximally allowed conditions as per Table 2 (see section 4.2.1).
- MMT-8 score ≥144, with at least 3 other CSM to be normal or near normal as per the following criteria: Visual Analogue Scale [VAS] of patient global disease activity ≤2 cm, physician's global disease activity ≤2 cm, extra-muscular disease activity ≤2 cm; no muscle enzyme >4 times upper limit of normal due to myositis, Health Assessment Questionnaire [HAQ] ≤0.25.
- Males or females ≥ 18 to <80 years of age.
- Voluntarily given, fully informed written consent obtained from subject before any study-related procedures are conducted.
- Subject must be capable and willing to understand and comply with the relevant aspects of the study protocol.
Who cannot join
- Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured and at least 1 or 5 years, respectively, have passed since excision).
- Evidence of active malignant disease or malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors) or breast cancer diagnosed within the previous 10 years. Subjects >5 years (>10 years for breast cancer) of cancer diagnosis who have been treated and are in remission are allowed.
- Subjects with overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis or drug-induced myopathy.
- Subjects with immune-mediated necrotizing myopathy with absence of typical DM rash.
- Subjects with generalized, severe musculoskeletal conditions other than DM that prevent a sufficient assessment of the subject by the physician.
- Subjects who received blood or plasma-derived products (other than IGIV) or plasma exchange within the last 3 months before enrolment.
Show all 22Show fewer
- Subjects with administration of permitted concomitant medications exceeding the maximally allowed conditions as per section 4.2.1.
- Subjects with administration of forbidden concomitant medications within the washout periods as defined in Table 3: see section 4.2.2.
- Subjects starting or planning to start a physical therapy-directed exercise regimen during the trial. Subjects on stable physical therapy for >4 weeks are allowed but the regimen should remain the same throughout the trial.
- Cardiac insufficiency (New York Heart Association III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease.
- Severe liver disease, with signs of ascites and hepatic encephalopathy.
- Severe kidney disease (as defined by estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2).
- Known hepatitis B, hepatitis C or HIV infection.
- Subjects with a history of deep vein thrombosis within the last year prior to study enrolment or pulmonary embolism ever.
- Body mass index >40 kg/m2 and/or body weight >120 kg.
- Medical conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome).
- Known IgA deficiency with antibodies to IgA.
- History of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products or any component of octanorm 16.5% such as polysorbate 80 or to sodium chloride.
- Known blood hyperviscosity, or other hypercoagulable states.
- Subjects with a history of drug abuse within the past 5 years prior to study enrolment.
- Participating in another interventional clinical study with investigational treatment within 3 months prior to study enrolment. Subjects who participated in the Octagam 10% Dermatomyositis Study (GAM10-08) can be included.
- Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to apply an effective birth control method (as per protocol section 7.3.9 b) up to four weeks after the last IMP infusion received.
Trial locations and contacts
1 site in 1 country.
Russia1 site
I.M. SECHENOV FIRST MOSCOW STATE MEDICAL UNIVERSITY Rheumatology Department Of, Clinici Of Nephrology
Moscow, 119992
About this study
Official title: Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Dermatomyositis (SCGAM-02)
DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS
- Conditions
- Dermatomyositis
- Being tested
- Octanorm, Placebo
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctanormDrug
Octanorm 0.5g/kg/week
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Octanorm | Experimental | 0.5g/kg/week octanorm 16.5% Receives: Drug: Octanorm |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMT-8
MMT-8; a set of 8 designated muscles tested bilaterally [potential score 0 - 150]
Measured: 32 weeks
CDASI
The CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM patients for use in clinical practice or clinical/therapeutic studies.
Measured: 32 weeks
Physician's Global Disease Activity VAS Worsening
Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis).
Measured: 32 weeks
Secondary outcomes (56)
Extra-Muscular Disease Activity
Extra-muscular activity (part of MDAAT; a combined tool that captures the physician's assessment of disease activity of various organ systems using a scale from 0 = "Not present in the last 4 weeks" to 4 = "New - in the last 4 weeks [compared to the previous 4 weeks]" and a VAS).
Measured: 32 weeks
Muscle Enzymes - Aldolase
Measurement of aldolase in blood
Measured: 32 weeks
Muscle Enzymes - Creatine Kinase
Measurement of creatine kinase in blood
Measured: 32 weeks
Muscle Enzymes - Alanine Aminotransferase
Measurement of alanine aminotransferase in blood
Measured: 32 weeks
Muscle Enzymes - Aspartate Aminotransferase
Measurement of aspartate aminotransferase in blood
Measured: 32 weeks
Muscle Enzymes - Lactate Dehydrogenase
Measurement of lactate dehydrogenase in blood
Measured: 32 weeks
Health Assessment Questionnaire
- Health Assessment Questionnaire (HAQ; a generic rather than a disease-specific instrument; comprised of 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. There are 2 or 3 questions for each section. Scoring within each section is from 0 [without any difficulty] to 3 [unable to do]. For each section the score given to that section is the worst score within the section. The 8 scores of the 8 sections are summed and divided by 8).
Measured: 32 weeks
SF-36v2 Health Survey
The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index.
Measured: 32 weeks
Mean Change in TIS
Total Improvement Score
Measured: 32 weeks
Time to Clinically Important Deterioration
Time to clinically important deterioration
Measured: 32 weeks
Adverse Events
Occurrence of all adverse events
Measured: 32 weeks
TEEs
Monitoring safety with occurrence of all thromboembolic events (TEEs)
Measured: 32 weeks
HTRs
Monitoring safety with occurrence of all hemolytic transfusion reactions (HTRs)
Measured: 32 weeks
Injection Site Reactions
Monitoring safety by assessing local injection site reactions
Measured: 32 weeks
Blood Pressure
Monitoring safety through blood pressure values
Measured: 32 weeks
Heart Rate
Monitoring safety through heart rate values
Measured: 32 weeks
Body Temperature
Monitoring safety through body temperature values
Measured: 32 weeks
Respiratory Rate
Monitoring safety through respiratory rate values
Measured: 32 weeks
Physical Examination
The physical examination outcome will be analyzed based on changes from baseline as adverse events.
Measured: 32 Weeks
Sodium
Monitoring safety through lab sodium levels
Measured: 32 weeks
Potassium
Monitoring safety through lab potassium levels
Measured: 32 weeks
Glucose
Monitoring safety through lab glucose levels
Measured: 32 weeks
ALAT
Monitoring safety through lab ALAT levels
Measured: 32 weeks
ASAT
Monitoring safety through lab ASAT levels
Measured: 32 weeks
LDH
Monitoring safety through lab LDH levels
Measured: 32 weeks
Total Bilirubin
Monitoring safety through lab total bilirubin levels
Measured: 32 weeks
Blood Urea Nitrogen
Monitoring safety through lab blood urea nitrogen levels
Measured: 32 weeks
Urea
Monitoring safety through lab urea levels
Measured: 32 weeks
Creatinine
Monitoring safety through lab creatinine levels
Measured: 32 weeks
Albumin
Monitoring safety through lab albumin levels
Measured: 32 weeks
Hematocrit
Monitoring safety through lab hematocrit levels
Measured: 32 weeks
Hemoglobin
Monitoring safety through lab hemoglobin levels
Measured: 32 weeks
Red Blood Cell Count
Monitoring safety through lab red blood cell count levels
Measured: 32 weeks
White Blood Cell Count
Monitoring safety through lab white blood cell count levels
Measured: 32 weeks
Platelets
Monitoring safety through lab platelet levels
Measured: 32 weeks
Serum Haptoglobin
Monitoring safety through lab serum haptoglobin levels
Measured: 32 weeks
Plasma-Free Hemoglobin
Monitoring safety through lab plasma-free hemoglobin
Measured: 32 weeks
Direct Coombs' Test
Monitoring safety through Direct Coombs' test
Measured: 32 weeks
D-dimers
Monitoring safety through D-dimers test
Measured: 32 weeks
Serum IgG
Monitoring safety through lab IgG levels
Measured: 32 weeks
Aldolase
Monitoring safety through lab aldolase levels
Measured: 32 weeks
Creatine Kinase
Monitoring safety through lab creatine kinase levels
Measured: 32 weeks
Pregnancy Test
Monitoring safety through pregnancy test
Measured: 32 weeks
Urine Protein
Monitoring safety through lab urine protein levels
Measured: 32 weeks
Urine Glucose
Monitoring safety through lab urine glucose levels
Measured: 32 weeks
Urine pH
Monitoring safety through lab urine pH levels
Measured: 32 weeks
Urine Nitrite
Monitoring safety through lab urine nitrite levels
Measured: 32 weeks
Urine Ketones
Monitoring safety through lab urine ketone levels
Measured: 32 weeks
Urine Leukocytes
Monitoring safety through lab urine leukocyte levels
Measured: 32 weeks
Urine Hemoglobin
Monitoring safety through lab urine hemoglobin levels
Measured: 32 weeks
Urine Bilirubin
Monitoring safety through lab urine bilirubin levels
Measured: 32 weeks
Urine Urobilinogen
Monitoring safety through lab urine urobilinogen levels
Measured: 32 weeks
Urine Hemosiderin
Monitoring safety through lab urine hemosiderin levels
Measured: 32 weeks
HIV
Monitoring safety through HIV testing
Measured: 32 weeks
Hepatitis B
Monitoring safety through hepatitis B testing
Measured: 32 weeks
Hepatitis C
Monitoring safety through hepatitis C testing
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start2 Aug 2018
- Primary completion22 Nov 2018
- Study completion29 Nov 2018
Why it stopped: Study complexity, low study recruitment
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 DermatomyositisStudies of the same condition, open and under way.
- More trials run by OctapharmaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686969
- Sponsor's protocol ID
- SCGAM-02
- Status last verified
- Apr 2021
- First submitted
- 31 Aug 2018
- Last updated
- 23 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Dermatomyositis (SCGAM-02)
- ClinicalTrials.gov ID
- NCT03686969
- Acronym / sponsor ID
- SCGAM-02
- Conditions
- Dermatomyositis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study complexity, low study recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- 22 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Posted 23 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED PHASE III STUDY EVALUATING EFFICACY AND SAFETY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH DERMATOMYOSITIS
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octanorm | Experimental | Drug: Octanorm0.5g/kg/week octanorm 16.5% |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with diagnosis of definite or probable DM according to the Bohan and Peter criteria.
- Subjects who have responded to IGIV treatment as assessed by the treating physician and being on a stable dose for at least 3 months on 2 g/kg bodyweight (+/- 10%).
- For subjects being on other medication(s) for the treatment of DM (immunosuppressants, corticosteroids): a) subject was on such medication(s) at the start of IGIV treatment in the first place, and b) received such medication(s) for at least 3 months prior to study enrolment and at a stable dose for at least 4 weeks prior to study enrolment at the maximally allowed conditions as per Table 2 (see section 4.2.1).
- MMT-8 score ≥144, with at least 3 other CSM to be normal or near normal as per the following criteria: Visual Analogue Scale [VAS] of patient global disease activity ≤2 cm, physician's global disease activity ≤2 cm, extra-muscular disease activity ≤2 cm; no muscle enzyme >4 times upper limit of normal due to myositis, Health Assessment Questionnaire [HAQ] ≤0.25.
- Males or females ≥ 18 to <80 years of age.
Key exclusion criteria (22 listed)
- Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the diagnosis of cancer (except basal or squamous cell skin cancer or carcinoma in situ of the cervix that has been excised and cured and at least 1 or 5 years, respectively, have passed since excision).
- Evidence of active malignant disease or malignancies diagnosed within the previous 5 years (including hematological malignancies and solid tumors) or breast cancer diagnosed within the previous 10 years. Subjects >5 years (>10 years for breast cancer) of cancer diagnosis who have been treated and are in remission are allowed.
- Subjects with overlap myositis (except for overlap with Sjögren's syndrome), connective tissue disease associated DM, inclusion body myositis, polymyositis or drug-induced myopathy.
- Subjects with immune-mediated necrotizing myopathy with absence of typical DM rash.
- Subjects with generalized, severe musculoskeletal conditions other than DM that prevent a sufficient assessment of the subject by the physician.
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 |
|---|---|---|
| OctanormOctanorm 0.5g/kg/week | Drug | Octanorm |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
MMT-8
Time frame: 32 weeks
MMT-8; a set of 8 designated muscles tested bilaterally [potential score 0 - 150]
CDASI
Time frame: 32 weeks
The CDASI is a clinician-scored single page instrument that separately measures activity and damage in the skin of DM patients for use in clinical practice or clinical/therapeutic studies.
Physician's Global Disease Activity VAS Worsening
Time frame: 32 weeks
Physician's Global Disease Activity (10 cm VAS assessing global disease activity from "No evidence of disease activity" to "Extremely active or severe disease activity"; Disease Activity being defined as potentially reversible pathology or physiology resulting from the myositis).
56 secondary outcomes
Extra-Muscular Disease Activity
Time frame: 32 weeks
Muscle Enzymes - Aldolase
Time frame: 32 weeks
Muscle Enzymes - Creatine Kinase
Time frame: 32 weeks
Muscle Enzymes - Alanine Aminotransferase
Time frame: 32 weeks
Muscle Enzymes - Aspartate Aminotransferase
Time frame: 32 weeks
Muscle Enzymes - Lactate Dehydrogenase
Time frame: 32 weeks
Health Assessment Questionnaire
Time frame: 32 weeks
SF-36v2 Health Survey
Time frame: 32 weeks
Mean Change in TIS
Time frame: 32 weeks
Time to Clinically Important Deterioration
Time frame: 32 weeks
Adverse Events
Time frame: 32 weeks
TEEs
Time frame: 32 weeks
HTRs
Time frame: 32 weeks
Injection Site Reactions
Time frame: 32 weeks
Blood Pressure
Time frame: 32 weeks
Heart Rate
Time frame: 32 weeks
Body Temperature
Time frame: 32 weeks
Respiratory Rate
Time frame: 32 weeks
Physical Examination
Time frame: 32 Weeks
Sodium
Time frame: 32 weeks
Potassium
Time frame: 32 weeks
Glucose
Time frame: 32 weeks
ALAT
Time frame: 32 weeks
ASAT
Time frame: 32 weeks
LDH
Time frame: 32 weeks
Total Bilirubin
Time frame: 32 weeks
Blood Urea Nitrogen
Time frame: 32 weeks
Urea
Time frame: 32 weeks
Creatinine
Time frame: 32 weeks
Albumin
Time frame: 32 weeks
Hematocrit
Time frame: 32 weeks
Hemoglobin
Time frame: 32 weeks
Red Blood Cell Count
Time frame: 32 weeks
White Blood Cell Count
Time frame: 32 weeks
Platelets
Time frame: 32 weeks
Serum Haptoglobin
Time frame: 32 weeks
Plasma-Free Hemoglobin
Time frame: 32 weeks
Direct Coombs' Test
Time frame: 32 weeks
D-dimers
Time frame: 32 weeks
Serum IgG
Time frame: 32 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Dermatomyositis
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
Active, not recruitingPhase 2
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
Dermatomyositis, Myositis
RecruitingObservational study
Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingPhase 2
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
Dermatomyositis
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 record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octanorm in people with Dermatomyositis, run by Octapharma at 1 site in Russia.
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 7 inclusion and 22 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 23 Apr 2021. 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 Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Apr 2021). 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?
MMT-8 (time frame: 32 weeks). The study lists 3 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 23 Apr 2021.