Chronic Liver DiseasePhase 2GRI-201NCT02949375
Trial to Examine the Effect of Two Doses of GRI-0621 in Patients With Chronic Liver Disease
A Phase 2 study testing Active Comparator:4.5mg GRI-0621 and Active Comparator: 6.0mg GRI-0621 in people with Chronic Liver Disease, run by GRI Bio Operations, Inc. at 1 site in South Africa.
Trial summary
Primary objectives: To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- Active Comparator:4.5mg GRI-0621 and Active Comparator: 6.0mg GRI-0621
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteSouth Africa
- Study dates
- Sep 2015to Jun 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A participant will be eligible for participation in the trial if all of the following inclusion criteria are met:
- Completion of the written informed consent process for trial participation prior to all trial-related procedures, including HIV testing.
- Male or female participants aged 18 to 65 years.
- Female participants of child-bearing potential must practice an effective method of birth control from four weeks prior to randomization and agree to continue this until 6 months after the completion of the end-of-trial follow-up visit. Effective birth control must include two methods, one of which must be a barrier method. Female participants are considered not to be of child-bearing potential if they are post-menopausal (12 months of spontaneous amenorrhoea with an appropriate clinical profile, or 6 months of spontaneous amenorrhoea with local laboratory serum follicle-stimulating hormone [FSH] levels in keeping with post-menopause) or surgically sterile (after bilateral oophorectomy, hysterectomy or salpingectomy). For the purpose of this trial any participant who has had a tubal ligation will not be considered surgically sterile due to the teratogenic nature of this class of chemical entities.
- Female participants of child-bearing potential must have negative serum and urine pregnancy tests at screening and randomization respectively.
- History of chronic liver disease [CLD] as a result of viral hepatitis, alcoholic steatohepatitis [ASH] or non-alcoholic steatohepatitis [NASH].
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- Evidence of viral hepatitis, ASH or NASH as described beneath:
- Viral Hepatitis:
- Hepatitis C virus [HCV] infection as confirmed by the presence of HCV RNA (determined by PCR) and no other cause of liver disease or
- Hepatitis B virus [HBV] infection as confirmed by the presence of HBV DNA > 104 copies/ml (determined by the Roche COBA TaqMan HBV DNA assay) and no other cause for liver disease or
- Hepatitis C and B co-infection (as defined above) OR
- ASH:
- Findings and history consistent with the diagnosis of ASH in the opinion of the investigator OR
- NASH:
- Absence of viral hepatitis and
- A history of no or minimal alcohol use and
- Findings and history consistent with the diagnosis of NASH in the opinion of the investigator
- Body Mass Index (BMI) of 18 to 39kg/m2.
- Weight ≥ 45kg
- ALT > 1.5 x ULN but less than 10 x ULN on two occasions during the screening period (Day -28 to Day -1). The second occasion must be between Day -7 and Day -1.
- An ability to communicate well with the investigator and to understand and comply with the requirements of the trial.
- Agree to stay in contact with the trial site for the duration of the trial, provide updated contact information as necessary.
Who cannot join
- A participant will not be eligible for trial participation if any of the following exclusion criteria are met:
- Use of any other investigational drug within 30 days or five half-lives (whichever is longer) of the first dose of GRI-0621.
- Current pregnancy or lactation.
- A history of anaphylaxis or severe hypersensitivity to any drugs.
- A known hypersensitivity to any component of the investigational product or to any other retinoids.
- ALT or AST > 10 x ULN on any occasion during the screening period (Day -28 to Day -1)
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- ALT or AST known to have been > 10 X ULN on any occasion during the 2 months prior to screening.
- Any of the following laboratory abnormalities at screening:
- Serum creatinine > 1.5 x ULN
- Hemoglobin < 10.0 g/L
- Platelets < 75 x 109/L
- White cell count < 3.0 x 109/L.
- Known hypothyroidism requiring treatment or laboratory results suggestive of hypothyroidism at screening (thyroxine [T4] < LLN and thyroid-stimulating hormone [TSH] > ULN).
- Any clinically significant ECG abnormalities.
- Current or recent (during the 3 months prior to screening) or required treatment for tuberculosis infection.
- A history of any malignancy (other than treated localized basal cell carcinoma of the skin) in the last 5 years.
- A history or known presence of osteoporosis.
- A history of arthritic conditions requiring treatment with symptom- or disease-modifying drugs for > 4 weeks.
- A history of atopic dermatitis.
- History or presence of decompensated liver disease
- Previous histological evidence of hepatic fibrosis stage > 3.
- The presence of any acute disorder that could further compromise the hepato-biliary system including but not limited to acute infectious or alcoholic hepatitis, acute pancreatitis, biliary obstruction and cholecystitis.
- History or presence of hepatocellular carcinoma, hepatic abscess, biliary obstruction or portal vein thrombosis as confirmed by ultrasound, CT or MRI scans.
- A history of severe gastro-intestinal bleeding requiring blood transfusion therapy (packed cells or whole blood).
- Any surgical or medical condition other than CLD which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the participant or the objectives of the trial including but not limited to inflammatory bowel disease, major gastro-intestinal surgery (e.g. gastrectomy, gastroenterostomy or bowel resection) or pancreatic injury.
- A history of hemachromatosis, Wilson's disease, alpha-1-antitrypsin deficiency or celiac disease.
- Previous organ or hematopoietic transplantation.
- HIV infection confirmed by a positive HIV test result.
- Any other medical condition which, in the opinion of the investigator, could affect the participant's health during trial participation or could compromise his/her ability to participate in the trial. This includes but is not limited to significant cardiovascular, respiratory, renal, neurological, hematological, immunological, endocrinological or metabolic disorders.
- Any psychiatric or mental disorder which could limit the validity of the informed consent or the participant's ability to comply with the protocol requirements.
- A history of drug abuse during the 12 months prior to screening, or evidence of such abuse as indicated by urine testing for drugs of abuse at screening that, in the opinion of the investigator, may be indicative of potential participant adherence issues during the course of the trial.
- In the opinion of the investigator, the participant is not reliable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-Controlled Phase 2a Trial of GRI-0621 in Patients With Chronic Liver Disease
Primary objectives:
To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation.
Read more
To assess the safety and tolerability of GRI-0621 at these two doses.
Secondary objectives:
To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a second marker of liver inflammation.
To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from baseline measured at the different trial time points.
To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or apoptosis.
To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.
To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic liver disease.
Exploratory objectives:
To assess the effect, if any, that the investigational product may have on serum triglyceride levels.
Read the detailed description
This is a multi- centre, double-blind, randomized, placebo-controlled phase 2a trial in participants aged 18 to 65 years with chronic liver disease. It is designed to assess the safety, tolerability and efficacy of both 4.5mg and 6mg of GRI-0621 when administered once daily for 28 days.
A total of 60 participants will be randomised to received 4.5mg or 6mg of GRI-0621 or matching placebo in a 1:1:1 ratio. The investigational product will be administered orally once daily in the morning for a duration of 28 days. Participants will return to the clinic for follow-up safety and efficacy assessments on Days 7, 14, 21 and 28. Additionally, PK sampling will be performed on Days 7 and 28, and samples for immunological assays to assess the activity of NKT cells will be drawn on Days 0 (baseline) and 28. An end-of-trial follow-up visit will be performed 14 days after the last dose of the investigational product on Day 42.
The primary efficacy objective will be measured by the change from baseline to Day 28 in serum ALT levels. The baseline ALT level will be calculated as the mean of the Day -7 to -1 and Day 0 serum ALT results.
Safety and tolerability will be measured by the incidence and severity of adverse events and changes in physical examination findings, physical measurements, vital signs, ECG findings and standard laboratory safety parameters (including hematology, clinical chemistry, coagulation parameters and urinalysis).
- Conditions
- Chronic Liver Disease
- Being tested
- Placebo Comparator, Active Comparator:4.5mg GRI-0621, Active Comparator: 6.0mg GRI-0621
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo ComparatorDrug
Placebo gel capsule to be taken daily for 28 days
Active Comparator:4.5mg GRI-0621Drug
4.5mg GRI-0621 gel capsule to be taken daily for 28 days
Active Comparator: 6.0mg GRI-0621Drug
6.0mg GRI-0621 gel capsule to be taken daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Gel capsule containing Placebo to be taken once per day Receives: Drug: Placebo Comparator |
| 4.5mg GRI-0621 | Active comparator | 4.5mg GRI-0621 gel capsule to be taken once per day Receives: Drug: Active Comparator:4.5mg GRI-0621 |
| 6mg GRI-0621 | Active comparator | 6mg GRI-0621 gel capsule to be taken once per day Receives: Drug: Active Comparator: 6.0mg GRI-0621 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum ALT levels from Day 0 (baseline) to Day 28
To evaluate the change in serum ALT levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation.
Measured: 0 and 28 days
Secondary outcomes (9)
Change in serum AST levels from Day 0 (baseline) to Day 28
To assess the change in serum AST levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a second marker of liver inflammation.
Measured: 0 and 28 days
Response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from Day 0 (baseline) measured at the different trial time points.
Measured: 0 and 28 days
Changes in serum cytokeratin 18 (CK-18) levels from Day 0 (baseline) to Day 28,
To assess changes in serum cytokeratin 18 (CK-18) levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or apoptosis.
Measured: 0 and 28 days
NKT cell activity measured by multi-color flow cytometry at Day 0 (baseline) and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.
Measured: 0 and 28 days
Measurement of GRI-0621 peak plasma concentration [Cmax] on Day 7 and Day 28.
Measured: 7 and 28 days
Measurement of GRI-0621 time to reach Cmax [Tmax].
Measured: 7 and 28 days
Measurement of GRI-0621 half life [t1/2]
Measured: 7 and 28 days
Measurement of GRI-0621 clearance [CL] on Days 7 and 28
Measured: 7 and 28 days
Measurement of GRI-0621 volume of distribution [Vd] on Days 7 and 28
Measured: 7 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study startSep 2015
- Primary completionNov 2018
- Study completionJun 2019
Why it stopped: Administrative decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver 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
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- GRI Bio Operations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mpho K Kgomo, MBBCH, Principal investigator, Department Head; Gastroenetrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949375
- Sponsor's protocol ID
- GRI-0621-201
- Acronym
- GRI-201
- Status last verified
- Aug 2019
- First submitted
- 26 Oct 2016
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-Controlled Phase 2a Trial of GRI-0621 in Patients With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT02949375
- Acronym / sponsor ID
- GRI-201 / GRI-0621-201
- Conditions
- Chronic Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative decision
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GRI Bio Operations, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2015 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 31 Oct 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.
Primary objectives:
To evaluate the change in serum alanine transaminase [ALT] levels from Day 0 to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation.
To assess the safety and tolerability of GRI-0621 at these two doses.
Secondary objectives:
To assess the change in serum aspartate transaminase [AST] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease and elevated serum levels of AST. Serum AST level will be used as a second marker of liver inflammation.
To evaluate the response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from baseline measured at the different trial time points.
To assess changes in serum cytokeratin 18 [CK-18] levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo, in patients with chronic liver disease. Serum CK-18 is used as a marker of hepatocyte cell death due to either necrosis or apoptosis.
To measure Natural Killer T lymphocyte [NKT] cell activity at baseline and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.
To describe the steady-state pharmacokinetics [PK] of GRI-0621 in patients with chronic liver disease.
Exploratory objectives:
To assess the effect, if any, that the investigational product may have on serum triglyceride levels.
Detailed description
This is a multi- centre, double-blind, randomized, placebo-controlled phase 2a trial in participants aged 18 to 65 years with chronic liver disease. It is designed to assess the safety, tolerability and efficacy of both 4.5mg and 6mg of GRI-0621 when administered once daily for 28 days.
A total of 60 participants will be randomised to received 4.5mg or 6mg of GRI-0621 or matching placebo in a 1:1:1 ratio. The investigational product will be administered orally once daily in the morning for a duration of 28 days. Participants will return to the clinic for follow-up safety and efficacy assessments on Days 7, 14, 21 and 28. Additionally, PK sampling will be performed on Days 7 and 28, and samples for immunological assays to assess the activity of NKT cells will be drawn on Days 0 (baseline) and 28. An end-of-trial follow-up visit will be performed 14 days after the last dose of the investigational product on Day 42.
The primary efficacy objective will be measured by the change from baseline to Day 28 in serum ALT levels. The baseline ALT level will be calculated as the mean of the Day -7 to -1 and Day 0 serum ALT results.
Safety and tolerability will be measured by the incidence and severity of adverse events and changes in physical examination findings, physical measurements, vital signs, ECG findings and standard laboratory safety parameters (including hematology, clinical chemistry, coagulation parameters and urinalysis).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Drug: Placebo ComparatorGel capsule containing Placebo to be taken once per day |
| 4.5mg GRI-0621 | Active comparator | Drug: Active Comparator:4.5mg GRI-06214.5mg GRI-0621 gel capsule to be taken once per day |
| 6mg GRI-0621 | Active comparator | Drug: Active Comparator: 6.0mg GRI-06216mg GRI-0621 gel capsule to be taken once per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- A participant will be eligible for participation in the trial if all of the following inclusion criteria are met:
- Completion of the written informed consent process for trial participation prior to all trial-related procedures, including HIV testing.
- Male or female participants aged 18 to 65 years.
- Female participants of child-bearing potential must practice an effective method of birth control from four weeks prior to randomization and agree to continue this until 6 months after the completion of the end-of-trial follow-up visit. Effective birth control must include two methods, one of which must be a barrier method. Female participants are considered not to be of child-bearing potential if they are post-menopausal (12 months of spontaneous amenorrhoea with an appropriate clinical profile, or 6 months of spontaneous amenorrhoea with local laboratory serum follicle-stimulating hormone [FSH] levels in keeping with post-menopause) or surgically sterile (after bilateral oophorectomy, hysterectomy or salpingectomy). For the purpose of this trial any participant who has had a tubal ligation will not be considered surgically sterile due to the teratogenic nature of this class of chemical entities.
- Female participants of child-bearing potential must have negative serum and urine pregnancy tests at screening and randomization respectively.
Key exclusion criteria (32 listed)
- A participant will not be eligible for trial participation if any of the following exclusion criteria are met:
- Use of any other investigational drug within 30 days or five half-lives (whichever is longer) of the first dose of GRI-0621.
- Current pregnancy or lactation.
- A history of anaphylaxis or severe hypersensitivity to any drugs.
- A known hypersensitivity to any component of the investigational product or to any other retinoids.
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 |
|---|---|---|
| Placebo ComparatorPlacebo gel capsule to be taken daily for 28 days | Drug | Placebo Arm |
| Active Comparator:4.5mg GRI-06214.5mg GRI-0621 gel capsule to be taken daily for 28 days | Drug | 4.5mg GRI-0621 |
| Active Comparator: 6.0mg GRI-06216.0mg GRI-0621 gel capsule to be taken daily for 28 days | Drug | 6mg GRI-0621 |
Primary outcome
Change in serum ALT levels from Day 0 (baseline) to Day 28
Time frame: 0 and 28 days
To evaluate the change in serum ALT levels from baseline to Day 28, following daily doses of 4.5 or 6mg of GRI-0621 compared to placebo, in patients with chronic liver disease and elevated serum levels of ALT. Serum ALT level will be used as a marker of liver inflammation.
9 secondary outcomes
Change in serum AST levels from Day 0 (baseline) to Day 28
Time frame: 0 and 28 days
Response to 4.5mg GRI-0621 versus 6mg GRI-0621 in terms of the change in serum ALT levels from Day 0 (baseline) measured at the different trial time points.
Time frame: 0 and 28 days
Changes in serum cytokeratin 18 (CK-18) levels from Day 0 (baseline) to Day 28,
Time frame: 0 and 28 days
NKT cell activity measured by multi-color flow cytometry at Day 0 (baseline) and at Day 28 following daily doses of 4.5 or 6mg of GRI-0621 or matching placebo.
Time frame: 0 and 28 days
Measurement of GRI-0621 peak plasma concentration [Cmax] on Day 7 and Day 28.
Time frame: 7 and 28 days
Measurement of GRI-0621 time to reach Cmax [Tmax].
Time frame: 7 and 28 days
Measurement of GRI-0621 half life [t1/2]
Time frame: 7 and 28 days
Measurement of GRI-0621 clearance [CL] on Days 7 and 28
Time frame: 7 and 28 days
Measurement of GRI-0621 volume of distribution [Vd] on Days 7 and 28
Time frame: 7 and 28 days
Results and safety
The study was stopped early (reason given: Administrative decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Mpho K Kgomo, MBBCH principal investigator
Department Head; Gastroenetrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Comparator:4.5mg GRI-0621 and Active Comparator: 6.0mg GRI-0621 in people with Chronic Liver Disease, run by GRI Bio Operations, Inc. at 1 site in South Africa.
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 22 inclusion and 32 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 9 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 South Africa. 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 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?
The study was stopped early (reason given: Administrative decision). 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?
Change in serum ALT levels from Day 0 (baseline) to Day 28 (time frame: 0 and 28 days). 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 9 Aug 2019.