Fabry DiseasePhase 2NCT06114329
Study of the Safety and Biologic Activity of AL01211 in Treatment Naive Males With Classic Fabry Disease
A Phase 2 study testing AL01211 in people with Fabry Disease, run by AceLink Therapeutics, Inc. at 6 sites in China.
Trial summary
This is a Phase II, open-label study designed to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of AL01211 in male subjects with classic Fabry disease who have never received any treatment (eg. ERT or chaperone therapy). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Fabry Disease
- What is being tested?
- AL01211
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 6 sitesChina
- Study dates
- 25 Oct 2023to Jun 2026
- Phase
- Phase 2
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male subjects with classic Fabry mutations with between 18 and 60 years of age, inclusive, at screening.
- Have never received any Fabry disease-specific treatment (eg. ERT, chaperone therapy).
- Signed and dated informed consent prior to any study mandated procedure.
- Confirmed diagnosis of Fabry disease as documented by the presence of a Fabry genetic variant of known significance and documented (within 10 years prior to study entry) leukocyte αGAL activity of <4 nmol/hr/mg or plasma αGAL activity of <1.5 nmol/hr/mL. If the genetic variant is not known or available, genetic test will be done to document the genetic variation after obtaining the patient's informed consent. If documented leukocyte or plasma αGAL activity is unavailable, the subject must consent to plasma αGAL activity screening.
- eGFR ≥50 mL/min/1.73 m2 by CKD-EPI Creatinine-Cystatin Equation (2021) at the screening visit.
- Subject agrees to comply with all procedural requirements as presented in the protocol, including participation in observational period which extends beyond the planned 52-week treatment duration of the study and 1 month follow-up visit.
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- For subjects receiving renin-angiotensin-aldosterone system (RAAS) inhibitors/blockers (ACEIs, ARBs, aldosterone receptor antagonists) or sodium-glucose cotransporter-2 (SGLT2) inhibitors, the dose should be stable (ie, prescribed dose and frequency) for at least the immediate 3 months prior to screening.
- Symptom or clinical finding of ≥1 of the characteristic features of Fabry disease, such as, but not limited to, neuropathic pain, symptoms of gastrointestinal, renal, or cardiac dysfunction.
- Willing to undergo opthalmological examination with photodocumentation at baseline and at specified times during the study.
- Plasma Lyso GL3 ≥25 ng/mL.
Who cannot join
- Subject on regular dialysis for the treatment of chronic kidney disease or has undergone a kidney transplant.
- Clinically significant abnormal liver function judged by the investigator, including but not limited to serum total bilirubin > 1.5 the upper limit of normal [ULN], serum alanine aminotransferase > 2 times the ULN, or aspartate aminotransferase >2 times the ULN).
- Scheduled in-patient hospitalization, including elective surgery, during the study.
- A positive result on any of the following tests: hepatitis B surface antigen (HBsAg) (If HBsAg is positive, hepatitis B virus DNA needs to be tested, and the copy number >ULN), antihepatitis C virus antibodies, anti-human immunodeficiency virus 1 and 2 antibodies.
- A cortical cataract (COR) >one quarter of the lens circumference (Grade COR-2) or a posterior subcapsular cataract (PSC) with about 30% opacity (Grade PSC-2), according to World Health Organization grading. Subjects with nuclear cataracts are not excluded.
- Currently receiving, or has received within the past month, potentially cataractogenic medications, including a chronic regimen (more frequently than once every 2 weeks) of any route of corticosteroids (limited to medium and high-potency topical steroids; intranasal steroids are acceptable) or any medication that may cause cataracts (such as phenothiazines and miotics, amiodarone, allopurinol and phenytoin) according to the Prescribing Information.
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- Male subjects with partners of child-bearing potential who do not agree to use a medically accepted, highly effective method of contraception during the study until 3 months after the last administration of study drug. Male subjects must be willing to withhold from any sperm donation during the study and up to 3 months after the last dose of study treatment.
- Presence of any medical, emotional, behavioral, or psychological condition that, in the judgment of the investigator, would interfere with the subject's compliance with the requirements of the study or interpretation of the results.
- Prior participation in a study involving an investigational drug within 90 days since the end of the study or within 5 half lives since the last dose of investigational drug, whichever is longer.
- Unwilling to comply with the requirements of the protocol.
- Known and documented cardiovascular event (eg, myocardial infarction, unstable angina), cerebrovascular event (eg, stroke, transient ischemic attack), or clinically significant unstable cardiac disease (eg, uncontrolled symptomatic arrhythmia or congestive heart failure of New York Heart Association Class III or IV) in the 6 months prior to screening.
- Any cardiac disease that could mimic Fabry disease or confound cardiac measurement, such as (non-Fabry related) hypertrophic cardiomyopathy or the presence of a pacemaker or implantable cardioverter/defibrillator; any contraindications to MRI measurement (eg, cerebral aneurysm clips).
- History of acute kidney injury in the 12 months prior to screening, including specific kidney diseases (eg, acute interstitial nephritis, acute glomerular and vasculitic renal diseases), nonspecific conditions (eg, ischemia and toxic injury), and extrarenal pathology (eg, prerenal azotemia and acute postrenal obstructive nephropathy).
- Subjects received herbal medicines within 14 days prior to screening.
- The participant had received strong or moderate inducers or inhibitors of Cytochrome P450 3A4 (CYP3A4) within 14 days prior to enrollment or within 5 times the elimination half-life or PD half-life of the medication, whichever is longer; Ingested grapefruit, grapefruit juice, or grapefruit products within 72 hours prior to initial administration, or were unwilling to avoid grapefruit, grapefruit juice, or grapefruit products during treatment.
- Any other situations that the investigator considers unsuitable for the patient to participate in this study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610044
- Recruiting
The First Affiliated Hospital of Sun Yat sen University
Guangzhou, Guangdong, 510062
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Shanghai, 200025
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Phase II, Open-label Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy in Males With Classic Fabry Disease Who Have Never Received Any Treatment
This is a Phase II, open-label study designed to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of AL01211 in male subjects with classic Fabry disease who have never received any treatment (eg. ERT or chaperone therapy). Eligible subjects will receive 182 days (26 weeks) of study treatment as the primary study period followed by an extension period. The total study duration for a subject is up to at most 2 years including the primary period of 26 weeks.
- Conditions
- Fabry Disease
- Being tested
- AL01211
- Medical subject headings
- Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL01211Drug
AL01211 is a novel, proprietary, selective GCS inhibitor with high potency against GCS with limited off target activity.
| Study group | Role | What they receive |
|---|---|---|
| AL01211 30 mg, once daily | Experimental | 9 subjects will first be enrolled in this arm, receiving 30 mg AL01211 treatment, once daily Receives: Drug: AL01211 |
| AL01211 60 mg, once daily | Experimental | After enrolling into 30 mg arm is completed and preliminary data show good safety, 9 subjects will be enrolled in this arm, receiving 60 mg AL01211 treatment, once daily Receives: Drug: AL01211 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Number of subjects with TEAEs will be evaluated. AEs will be coded by using the current version of the Medical Dictionary for Regulatory Activities and summarized by system organ class, preferred term, and dose level for the number and percent of AEs reported, the number of subjects reporting each AE, and the number of subjects with any AE.
Measured: 104 weeks
Secondary outcomes (24)
The pharmacodynamics of AL01211 by measuring plasma GL1 level
Plasma level of GL1 will be determined by Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).
Measured: Baseline, weeks 2, 4, 8, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring plasma GL3 level
Plasma levels of GL3 will be determined by Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).
Measured: Baseline, weeks 2, 4, 8, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring plasma lyso globotriaosylceramide (Lyso GL3) level
Plasma levels of Lyso-GL3 will be determined by Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).
Measured: Baseline, weeks 2, 4, 8, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring urine GL3 level
Urine levels of GL3 will be determined by Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).
Measured: Baseline, weeks 4, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring urine lyso globotriaosylceramide (Lyso GL3) level
Urine levels of Lyso-GL3 will be determined by Liquid Chromatography with tandem mass spectrometry (LC-MS-MS).
Measured: Baseline, weeks 4, 13, 26, 52, 104
The pharmacokinetics of AL01211 in plasma
Plasma samples will be collected, and AL01211 plasma concentrations will be measured with Liquid Chromatography with tandem mass spectrometry (LC-MS/MS).
Measured: Weeks 1, 2, 4, 8, 13, 26, 52, 104
The pharmacokinetics of AL01211 in urine
Urine samples will be collected, and AL01211 urine concentrations will be measured with Liquid Chromatography with tandem mass spectrometry (LC-MS/MS).
Measured: weeks 1 and 13
The effect of AL01211 on renal function: eGFR
Change from Baseline in estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine-Cystatin Equation (2021) at Weeks 2, 4, 8, 13, 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on renal function: UPCR
Change from Baseline in urine protein/creatinine ratio (UPCR) at Weeks 13, 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on renal function: UACR
Change from Baseline in urine albumin/creatinine ratio (UACR) at Weeks 13, 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on cardiac function: MRI±gadolinium
Change from Baseline in MRI±gadolinium measurements at Weeks 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on cardiac function: troponin T
Change from Baseline in plasma troponin T level at Weeks 2, 4, 8, 13, 26, 52 and 104.
Measured: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: BPI-SF
Change from Baseline in Brief Pain Inventory-Short Form (BPI-SF) at Weeks 4, 8, 13, 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: average weekly pain severity during Fabry crises
Change from Baseline in average weekly pain severity during Fabry crises (episodic pain attacks) as assessed by an 11-point Numeric Rating Scale (NRS) at Weeks 4, 8, 13, 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: weekly frequency of Fabry crises
Change from Baseline in weekly frequency of Fabry crises (episodic pain attacks) at Weeks 4, 8, 13, 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: weekly frequency of use of pain medication
Change from Baseline in weekly frequency of use of pain medication at Weeks 4, 8, 13, 26, 52, 104.
Measured: 104 weeks
The effect of AL01211 on symptoms of gastrointestinal disturbance
Change from Baseline in average weekly gastrointestinal symptom diary up to at Weeks 4, 8, 13, 26, 52, 104.
Measured: 104 weeks
The pharmacodynamics of AL01211 by measuring GL3 inclusion in kidney biopsies
Change from baseline in histological scoring of the number of GL-3 inclusions per kidney interstitial capillary (KIC) at Week 52 and 104. (optional)
Measured: Baseline, weeks 52, and 104
The effect of AL01211 on quality of life: EQ-5D-5L
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Change from Baseline in EQ-5D-5L at Weeks 13, 26, 52 and 104 will be assessed.
Measured: 104 weeks
The effect of AL01211 on overall disease burden
Fabry Outcome Survey Mainz Severity Score Index (FOS-MSSI) is a tool for clinicians to evaluate the severity and progression of Fabry disease in adult patients. A higher score on FOS-MSSI means a higher disease burden. It will be assessed at Weeks 13, 26, 52 and 104
Measured: 104 weeks
The effect of AL01211 on clinician reported global impression of severity of disease
Change from Baseline in Clinical Global Impression of Severity (CGI-S) score at Weeks 4, 8, 13, 26, 52 and 104. A higher score (from 0 to 3) means a greater severity.
Measured: 104 weeks
The effect of AL01211 on clinician reported global impression of change of disease
Change from Baseline in Clinical Global Impression of Change (CGI-C) score assessed at Weeks 4, 8, 13, 26, 52 and 104. A higher score (from 1 to 5) means a greater overall worsening of symptoms.
Measured: 104 weeks
The effect of AL01211 on patient reported global impression of severity of disease
Change from Baseline in Patient Global Impression of Severity (PGI-S) score assessed at Weeks 4, 8, 13, 26, 52 and 104. A higher score (from 0 to 3) means a greater severity.
Measured: 104 weeks
The effect of AL01211 on patient reported global impression of change of disease
Change from Baseline in Patient Global Impression of Change (PGI-C) score assessed at Weeks 4, 8, 13, 26, 52 and 104. A higher score (from 1 to 5) means a greater overall worsening of symptoms.
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start25 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fabry DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AceLink Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nan Chen, Dr., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114329
- Sponsor's protocol ID
- AL01211-202
- Status last verified
- Nov 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-label Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy in Males With Classic Fabry Disease Who Have Never Received Any Treatment
- ClinicalTrials.gov ID
- NCT06114329
- Acronym / sponsor ID
- AL01211-202
- Conditions
- Fabry Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- AceLink Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Nov 2023 (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.
This is a Phase II, open-label study designed to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of AL01211 in male subjects with classic Fabry disease who have never received any treatment (eg. ERT or chaperone therapy). Eligible subjects will receive 182 days (26 weeks) of study treatment as the primary study period followed by an extension period. The total study duration for a subject is up to at most 2 years including the primary period of 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL01211 30 mg, once daily | Experimental | Drug: AL012119 subjects will first be enrolled in this arm, receiving 30 mg AL01211 treatment, once daily |
| AL01211 60 mg, once daily | Experimental | Drug: AL01211After enrolling into 30 mg arm is completed and preliminary data show good safety, 9 subjects will be enrolled in this arm, receiving 60 mg AL01211 treatment, once daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male subjects with classic Fabry mutations with between 18 and 60 years of age, inclusive, at screening.
- Have never received any Fabry disease-specific treatment (eg. ERT, chaperone therapy).
- Signed and dated informed consent prior to any study mandated procedure.
- Confirmed diagnosis of Fabry disease as documented by the presence of a Fabry genetic variant of known significance and documented (within 10 years prior to study entry) leukocyte αGAL activity of <4 nmol/hr/mg or plasma αGAL activity of <1.5 nmol/hr/mL. If the genetic variant is not known or available, genetic test will be done to document the genetic variation after obtaining the patient's informed consent. If documented leukocyte or plasma αGAL activity is unavailable, the subject must consent to plasma αGAL activity screening.
- eGFR ≥50 mL/min/1.73 m2 by CKD-EPI Creatinine-Cystatin Equation (2021) at the screening visit.
Key exclusion criteria (16 listed)
- Subject on regular dialysis for the treatment of chronic kidney disease or has undergone a kidney transplant.
- Clinically significant abnormal liver function judged by the investigator, including but not limited to serum total bilirubin > 1.5 the upper limit of normal [ULN], serum alanine aminotransferase > 2 times the ULN, or aspartate aminotransferase >2 times the ULN).
- Scheduled in-patient hospitalization, including elective surgery, during the study.
- A positive result on any of the following tests: hepatitis B surface antigen (HBsAg) (If HBsAg is positive, hepatitis B virus DNA needs to be tested, and the copy number >ULN), antihepatitis C virus antibodies, anti-human immunodeficiency virus 1 and 2 antibodies.
- A cortical cataract (COR) >one quarter of the lens circumference (Grade COR-2) or a posterior subcapsular cataract (PSC) with about 30% opacity (Grade PSC-2), according to World Health Organization grading. Subjects with nuclear cataracts are not excluded.
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 |
|---|---|---|
| AL01211AL01211 is a novel, proprietary, selective GCS inhibitor with high potency against GCS with limited off target activity. | Drug | AL01211 30 mg, once daily, AL01211 60 mg, once daily |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: 104 weeks
Number of subjects with TEAEs will be evaluated. AEs will be coded by using the current version of the Medical Dictionary for Regulatory Activities and summarized by system organ class, preferred term, and dose level for the number and percent of AEs reported, the number of subjects reporting each AE, and the number of subjects with any AE.
24 secondary outcomes
The pharmacodynamics of AL01211 by measuring plasma GL1 level
Time frame: Baseline, weeks 2, 4, 8, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring plasma GL3 level
Time frame: Baseline, weeks 2, 4, 8, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring plasma lyso globotriaosylceramide (Lyso GL3) level
Time frame: Baseline, weeks 2, 4, 8, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring urine GL3 level
Time frame: Baseline, weeks 4, 13, 26, 52, 104
The pharmacodynamics of AL01211 by measuring urine lyso globotriaosylceramide (Lyso GL3) level
Time frame: Baseline, weeks 4, 13, 26, 52, 104
The pharmacokinetics of AL01211 in plasma
Time frame: Weeks 1, 2, 4, 8, 13, 26, 52, 104
The pharmacokinetics of AL01211 in urine
Time frame: weeks 1 and 13
The effect of AL01211 on renal function: eGFR
Time frame: 104 weeks
The effect of AL01211 on renal function: UPCR
Time frame: 104 weeks
The effect of AL01211 on renal function: UACR
Time frame: 104 weeks
The effect of AL01211 on cardiac function: MRI±gadolinium
Time frame: 104 weeks
The effect of AL01211 on cardiac function: troponin T
Time frame: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: BPI-SF
Time frame: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: average weekly pain severity during Fabry crises
Time frame: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: weekly frequency of Fabry crises
Time frame: 104 weeks
The effect of AL01211 on symptoms of neuropathic pain: weekly frequency of use of pain medication
Time frame: 104 weeks
The effect of AL01211 on symptoms of gastrointestinal disturbance
Time frame: 104 weeks
The pharmacodynamics of AL01211 by measuring GL3 inclusion in kidney biopsies
Time frame: Baseline, weeks 52, and 104
The effect of AL01211 on quality of life: EQ-5D-5L
Time frame: 104 weeks
The effect of AL01211 on overall disease burden
Time frame: 104 weeks
The effect of AL01211 on clinician reported global impression of severity of disease
Time frame: 104 weeks
The effect of AL01211 on clinician reported global impression of change of disease
Time frame: 104 weeks
The effect of AL01211 on patient reported global impression of severity of disease
Time frame: 104 weeks
The effect of AL01211 on patient reported global impression of change of disease
Time frame: 104 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
Nan Chen, Dr. principal investigator
Ruijin Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL01211 in people with Fabry Disease, run by AceLink Therapeutics, Inc. at 6 sites 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 10 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Acelink Clinical Trial (+86 (21) 54302251, info@acelinktherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: 104 weeks). 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 30 Jul 2024.