PsoriasisPhase 1NCT02649270
Tolerability, Safety and Pharmacokinetic Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese Psoriasis
A Phase 1 study testing T1h in people with Psoriasis, run by Biotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for psoriasis in India. The first trial in China is to evaluate the tolerability, safety, pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- T1h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Oct 2017
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranged from 18 to 55 years, males or females ( no less than 3 patients in each dose group)
- Patients with chronic plaque psoriasis for at least 6 months (until patients with an informed consent) with or without arthritis psoriasis
- BSA≥3% or PASI≥10
- PGA≥3
- Patients were eligible if wash-out period was no less than the time as follows:
- 2 weeks for topical retinoic acid or glucocorticoid therapy
Show all 14Show fewer
- 6 months for retinoic acid of this kind drugs therapy
- 2 weeks for light therapy
- 4 weeks for Psoralen combined with UV-A therapy
- 4 weeks for methotrexate(MTX),cyclophosphamide,cyclosporine and other immunosuppressive therapy
- 7 half life time periods for other systemic immunosuppressive therapy
- 8 weeks for Biological agents for psoriasis therapy
- Fertile males or females who are willing to adopt contraceptive methods (e.g. hormonal pitch, intrauterine device, condoms)
- Patients were voluntary to sign a written informed consent.
Who cannot join
- The females were pregnant, or lactating or showed positive urine pregnancy reaction during screening.
- Patients with erythroderma or pustular psoriasis.
- Patients receiving glucocorticoid systemic drug therapy.
- Patients previously or currently suffered from autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome ), or suffering from primary or secondary immunodeficiency or human immunodeficiency virus
- Patients with any active infection (nail bed induced fungal infections were excluded), chronic infections, and tuberculosis history.
- Patients with severe heart disease, heart failure, asthma, chronic obstructive pulmonary disease or neuropsychiatric diseases.
Show all 16Show fewer
- Patients previously or currently suffered from tumors including solid tumors, hematologic malignancies and carcinoma in situ.
- Patients with positive tests for hepatitis B surface antigen (HBsAg), hepatitis C serology (HCV-Ab) or human immunodeficiency virus (HIV-Ab)
- Patients with Hemoglobin < 90 g/L, white blood cell count <3.5 × 10^9 / L, neutrophil count <1.5 × 10^9 / L, or platelet count <80 × 10^9 / L
- Patients with more than doubled serum cereal third transaminase(ALT )and glutamic-oxaloacetic transaminase(AST) as the upper limit of the reference value or serum creatinine values were above the upper limit of the reference.
- Patients with a history of drug abuse or alcoholism
- Patients were allergic to a recombinant biologic agent or any component of proteins derived from murine
- Patients with surgery within three months or any planned surgery or laser skin treatment within six months
- Patients received any vaccination within 28 days
- Patients received any experimental drug treatment within three months
- Patients were not suitable determined by researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single and Multiple Dose -Based Tolerability, Safety and Pharmacokinetic Phase 1 Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese Patients With Psoriasis
The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for psoriasis in India. The first trial in China is to evaluate the tolerability, safety, pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with psoriasis.
Read the detailed description
The humanized recombinant anti-CD6 monoclonal antibody (T1h) is developed whose ligand binding properties of the original murine monoclonal antibody are preserved on the CD6 molecule. T1h monoclonal antibody has been approved for clinical studies of autoimmune diseases in Cuba and India, such as psoriasis and rheumatoid arthritis (RA).
Single and multiple dose based tolerability, safety and pharmacokinetic phase 1 Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese patients with psoriasis, 40 patients are enrolled. They are divided into 4 groups (0.2mg/kg, 0.4mg/kg, 0.8mg/kg, 1.6mg/kg) and each group includes 10 patients. First, these doses are all single-dose administration gradually from low then the doses 0.4mg/kg, 0.8mg/kg and 1.6mg/kg are multi-dose administration gradually from low.
- Conditions
- Psoriasis
- Being tested
- T1h
- Keywords
- Tolerability, Safety, Pharmacokinetic Study, preliminary pharmacodynamic study, Humanized Anti-CD6 Monoclonal Antibody(T1h)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T1hBiological
Also called Anti-CD6 Monoclonal Antibody
Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Experimental | 10 Psoriasis patients,T1h 0.2mg/kg,only single dose administration at week 1. Receives: Biological: T1h |
| Group2 | Experimental | 10 Psoriasis patients,T1h 0.4mg/kg ,first administration at week 1 and continous administration from fifth week for 9 weeks. Receives: Biological: T1h |
| Group3 | Experimental | 10 Psoriasis patients,T1h 0.8mg/kg,first administration at week 1 and continous administration from fifth week for 9 weeks. Receives: Biological: T1h |
| Group4 | Experimental | 10 Psoriasis patients,T1h 1.6mg/kg,first administration at week 1 and biweekly from fifth week for 9 weeks.
. Receives: Biological: T1h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: from patients with informed consents to 30 days after the last administration
Secondary outcomes (26)
single-dose ,Peak plasma concentration (Cmax) of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Area under the plasma concentration versus time curve( AUC(0-t)) of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Area under the plasma concentration versus time curve(AUC(0-∞))of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Time to peak(Tmax) of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Elimination rate constant （kel）of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Half time (t1/2) of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Total body clearance (CLs)of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Apparent volume of distribution(Vd) of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Mean residence time(MRT) of T1h
Measured: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
multiple dose,Time to peak(Tmax) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Peak plasma concentration in steady state(Css_max) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Minimum plasma concentration in steady state(Css_min) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Average plasma concentration in steady state(Css_avg) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose, Area under the plasma concentration versus time curve in steady state(AUCss) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Apparent volume of distribution in steady state (Vss) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Degree of fluctuation (DF) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Accumulation Index(AI) of T1h
Measured: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
Erythrocyte sedimentation rate(ESR)
Measured: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
C-reactive protein(CRP)
Measured: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Tumor Necrosis Factor -alpha(TNF-α)
Measured: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Interleukin (il)-6 (IL-6)
Measured: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
interferon--γ (IFN-γ)
Measured: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
CD6
Measured: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Psoriasis Area and Severity Index(PASI)
Measured: at the end of 4th week,8th week,12th week after administration
Physician's Global Assessment(PGA)
Measured: The 29th day,The 57th day,The 85th day and The 113th day after administration
Body surface area(BSA)
Measured: The 29th day,The 57th day,The 85th day and The 113th day after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startOct 2014
- Primary completionJun 2015
- Study completionOct 2017
Why it stopped: company strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- lihong liu, Principal investigator, Beijing Chao Yang Hospitalyanling he, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649270
- Sponsor's protocol ID
- BT-T1h-PSO-1
- Status last verified
- Apr 2023
- First submitted
- 12 May 2015
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single and Multiple Dose -Based Tolerability, Safety and Pharmacokinetic Phase 1 Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese Patients With Psoriasis
- ClinicalTrials.gov ID
- NCT02649270
- Acronym / sponsor ID
- BT-T1h-PSO-1
- Conditions
- Psoriasis
- Keywords
- Tolerability, Safety, Pharmacokinetic Study, preliminary pharmacodynamic study, Humanized Anti-CD6 Monoclonal Antibody(T1h)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: company strategy
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Biotech Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 7 Jan 2016 (estimated)
- 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 humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for psoriasis in India. The first trial in China is to evaluate the tolerability, safety, pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with psoriasis.
Detailed description
The humanized recombinant anti-CD6 monoclonal antibody (T1h) is developed whose ligand binding properties of the original murine monoclonal antibody are preserved on the CD6 molecule. T1h monoclonal antibody has been approved for clinical studies of autoimmune diseases in Cuba and India, such as psoriasis and rheumatoid arthritis (RA).
Single and multiple dose based tolerability, safety and pharmacokinetic phase 1 Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese patients with psoriasis, 40 patients are enrolled. They are divided into 4 groups (0.2mg/kg, 0.4mg/kg, 0.8mg/kg, 1.6mg/kg) and each group includes 10 patients. First, these doses are all single-dose administration gradually from low then the doses 0.4mg/kg, 0.8mg/kg and 1.6mg/kg are multi-dose administration gradually from low.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 | Experimental | Biological: T1h10 Psoriasis patients,T1h 0.2mg/kg,only single dose administration at week 1. |
| Group2 | Experimental | Biological: T1h10 Psoriasis patients,T1h 0.4mg/kg ,first administration at week 1 and continous administration from fifth week for 9 weeks. |
| Group3 | Experimental | Biological: T1h10 Psoriasis patients,T1h 0.8mg/kg,first administration at week 1 and continous administration from fifth week for 9 weeks. |
| Group4 | Experimental | Biological: T1h10 Psoriasis patients,T1h 1.6mg/kg,first administration at week 1 and biweekly from fifth week for 9 weeks. . |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age ranged from 18 to 55 years, males or females ( no less than 3 patients in each dose group)
- Patients with chronic plaque psoriasis for at least 6 months (until patients with an informed consent) with or without arthritis psoriasis
- BSA≥3% or PASI≥10
- PGA≥3
- Patients were eligible if wash-out period was no less than the time as follows:
Key exclusion criteria (16 listed)
- The females were pregnant, or lactating or showed positive urine pregnancy reaction during screening.
- Patients with erythroderma or pustular psoriasis.
- Patients receiving glucocorticoid systemic drug therapy.
- Patients previously or currently suffered from autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome ), or suffering from primary or secondary immunodeficiency or human immunodeficiency virus
- Patients with any active infection (nail bed induced fungal infections were excluded), chronic infections, and tuberculosis 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 |
|---|---|---|
| T1hAlso: Anti-CD6 Monoclonal AntibodyGiven T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration. | Biological | Group1, Group2, Group3, Group4 |
Primary outcome
Adverse events
Time frame: from patients with informed consents to 30 days after the last administration
26 secondary outcomes
single-dose ,Peak plasma concentration (Cmax) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Area under the plasma concentration versus time curve( AUC(0-t)) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Area under the plasma concentration versus time curve(AUC(0-∞))of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Time to peak(Tmax) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Elimination rate constant （kel）of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Half time (t1/2) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Total body clearance (CLs)of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Apparent volume of distribution(Vd) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Mean residence time(MRT) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
multiple dose,Time to peak(Tmax) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Peak plasma concentration in steady state(Css_max) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Minimum plasma concentration in steady state(Css_min) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Average plasma concentration in steady state(Css_avg) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose, Area under the plasma concentration versus time curve in steady state(AUCss) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Apparent volume of distribution in steady state (Vss) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Degree of fluctuation (DF) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Accumulation Index(AI) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
Erythrocyte sedimentation rate(ESR)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
C-reactive protein(CRP)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Tumor Necrosis Factor -alpha(TNF-α)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Interleukin (il)-6 (IL-6)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
interferon--γ (IFN-γ)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
CD6
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Psoriasis Area and Severity Index(PASI)
Time frame: at the end of 4th week,8th week,12th week after administration
Physician's Global Assessment(PGA)
Time frame: The 29th day,The 57th day,The 85th day and The 113th day after administration
Body surface area(BSA)
Time frame: The 29th day,The 57th day,The 85th day and The 113th day after administration
Results and safety
The study was stopped early (reason given: company strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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.
lihong liu principal investigator
Beijing Chao Yang Hospital
yanling he principal investigator
Beijing Chao Yang Hospital
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 T1h in people with Psoriasis, run by Biotech Pharmaceutical Co., Ltd. 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 14 inclusion and 16 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 27 Apr 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. 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 was stopped early (reason given: company strategy). Results are not available in the source record.
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?
Adverse events (time frame: from patients with informed consents to 30 days after the last administration). 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 Apr 2023.