Hepatocellular CarcinomaPhase 2/3ARTEMISNCT04797884
Electromagnetic Fields Versus Placebo For Child-Pugh A and B Patients With Advanced Hepatocellular Carcinoma
A Phase 2/3 study testing TheraBionic Device and Quality of Life Assessment in people with Hepatocellular Carcinoma, run by THERABIONIC INC. at 7 sites in United States.
Trial summary
The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- TheraBionic Device and Quality of Life Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 7 sitesUnited States
- Study dates
- Jul 2023to 30 Oct 2024
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven HCC that is locally advanced or metastatic OR
- Patients without biopsy confirmation are also eligible if they meet one of the following criteria:
- Radiologic diagnosis of HCC as per the AASLD guidelines OR
- Liver cirrhosis AND a liver mass that shows arterial phase hyperenhancement on triphasic computed tomography (CT) or MRI, AND either:
- Is ≥ 20 mm with either non-peripheral portal washout or an enhancing capsule OR
- Is 10-19 mm with non-peripheral portal venous washout AND an enhancing capsule
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- For Child-Pugh A participants: treatment failure (defined as documented radiological progression) and/or intolerance to at least two prior treatments with approved or experimental systemic therapies including atezolizumab plus bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilimumab, pembrolizumab or any other approved or experimental first line and/or second line therapy.
- Child-Pugh B participants are not required to have received any prior treatment.
- Measurable disease according to RECIST v 1.1.
- At least one target lesion that has not previously received any local therapy, such as surgery, radiation therapy, hepatic arterial embolization, transarterial chemoembolization (TACE), hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed by 20% or more according to RECIST v 1.1 and mRECIST for HCC.
- Patients with Child-Pugh A or B (at time of enrollment) as defined by the parameters contained in the Child-Pugh Calculator. Subjects with Child-Pugh score of B8-B9 may be included if they have:
- Albumin ≥ 2.8 mg/l AND
- Total Bilirubin ≤ 3.0mg/l.
- ECOG performance status of 0-2.
- At least 2 weeks must have elapsed since administration of any anticancer treatment prior to initiation of protocol therapy.
- Patients must be greater than or equal to 18 years old and must be able to understand and sign an informed consent.
- Female patients of childbearing potential and their partners and male patients must agree to use adequate contraception during the period of study treatment.
Who cannot join
- Known leptomeningeal disease. (Previously treated, asymptomatic central nervous system (CNS) metastases are eligible).
- Fibrolamellar HCC or combined hepatocellular-cholangiocarcinoma (cHCC-CC).
- Prior treatment with the TheraBionic Device.
- Patients with any of the following within the 12 months prior to registration: uncontrolled/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
- Pregnant or breastfeeding women.
- Patients with another active malignancy within the past one year except for treated cervical cancer in situ, treated in situ carcinoma of the bladder or treated non-melanoma carcinoma of the skin, low-risk prostate cancer not requiring active treatment, treated T1/T2 glottic cancer, treated stage 0 or stage I breast cancer not requiring adjuvant therapy or treated non-invasive bladder cancer.
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- Patients receiving calcium channel blockers and any agent blocking L-type of T-type Voltage Gated Calcium Channels, e.g., amlodipine, nifedipine, ethosuximide, ascorbic acid (vitamin C), etc. unless their medical treatment is modified to exclude calcium channel blockers prior to enrollment.
- Patients with curative treatment options available, including surgery or radiofrequency ablation, as assessed by their physician.
- Patients receiving other anticancer treatments.
- Patients that do not agree to be followed according to the study protocol.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 7 recruiting
- Not yet recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
Al B Benson, MD, albenson@nm.org
Al Benson, MD
- Not yet recruiting
DHR Health Advanced Care Center, DHR Oncology Institute
Edinburg, Texas, 78539
Prinicipal Investigator, l.drinkard@dhr-rgv.com
Lee Drinkard, MD
- Not yet recruiting
Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
Principal Investigator
James.PoseyIII@jefferson.edu
- Not yet recruiting
Oregon Health & Science University, Knight Cancer Institute
Portland, Oregon, 97239
Principal Investigator, kardosh@ohsu.edu
Adel Kardosh, MD
- Not yet recruiting
University of Texas Health Science Center, Mays Cancer Center
San Antonio, Texas, 78229
Principal Investigator, aroras@uthscsa.edu
Sukeshi P Arora, MD
- Not yet recruiting
Tampa General Hospital, Tampa General Cancer Center
Tampa, Florida, 33606
Principal Investigator, andreask@usf.edu
Andreas Karachristos, MD
- Recruiting
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
Study Nurse, snmoore@wakehealth.edu
Ravi Paluri, MD
About this study
Official title: A Randomized Study of Intrabucally Administered Electromagnetic Fields Versus Placebo for Patients With Child-Pugh A or B With Advanced Hepatocellular Carcinoma
The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Read the detailed description
Primary Objectives
To compare the overall survival between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare the patient-reported disease-related symptoms between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Secondary Objectives
To compare progression-free survival between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare safety and tolerability between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare the effect on levels of alpha-fetoprotein between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare global treatment side effect bother between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare patient-rated symptomatic adverse events between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- TheraBionic Device, Placebo Device, Quality of Life Assessment
- Keywords
- Child-Pugh A and B
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraBionic DeviceDevice
Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at one of the recruiting site, all other treatments will be self-administered at the patient's home.
Placebo DeviceDevice
Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at the recruiting site, all other treatments will be self-administered at the patient's home.
Quality of Life AssessmentDevice
Ancillary services
| Study group | Role | What they receive |
|---|---|---|
| TheraBionic Arm - Active Arm | Experimental | For subjects who are randomized to the active arm, the device will be programmed with hepatocellular carcinoma-specific modulation frequencies and will be activated for >200 one-hour treatment sessions. Receives: Device: TheraBionic Device; Device: Quality of Life Assessment |
| Placebo Arm | Placebo comparator | For subjects randomized to the placebo arm, the device will not emit any hepatocellular carcinoma-specific modulation frequencies and will be activated for >200 one-hour treatment sessions. Receives: Device: Placebo Device; Device: Quality of Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival.
Measured: Baseline to 6 months
Quality of Life Survey
Patient-reported hepatobiliary-specific disease-related symptoms will be assessed by the 18-item FACT-Hepatobiliary (Hep) subscale every cycle for the first 6 cycles then every other cycle thereafter, at the end of treatment, and at every 3 months during follow-up.
Measured: Baseline to 6 months
Secondary outcomes (7)
Progression-Free Survival
Progression free survival (PFS) will be compared between groups using a 2-sided log rank test. Kaplan-Meier survival curves for PFS will also be generated and median progression free survival and corresponding 95% confidence intervals will be estimated for each group
Measured: Up to 2 years
Proportion of Patients With Disease Control
Proportion of patients who respond and the corresponding 95% Clopper Pearson exact confidence intervals. Patients who are removed from study before the 6-month time point will be considered to not have disease control at that time point.
Measured: At 4 months and 6 months and up to 2 years
Proportion of Participants That Are Progression Free
we will determine the proportion of patients who are progression free after 12 weeks (after 2nd 6-week visit) and compare this between groups using a Fisher's exact test. In addition, the corresponding 95% Clopper Pearson exact confidence intervals will be calculated for the 4 month and 6 month progression free survival rates.
Measured: At 12 weeks, 4 months and 6 months and up to 2 years
Incidences of Adverse Events - CTCAE version 5.0
Using Common Terminology Criteria for Adverse Events [CTCAE], version 5.0, type, incidence, severity, timing, seriousness, and relatedness of adverse events and laboratory abnormalities will be assessed.
Measured: Up to 28 days after study treatment administration or until death
Changes in Alfa-Fetoprotein Levels
Investigators will examine whether these is any association between the AFP levels (potential biomarker for response) and the objective response observed for each participant. Average alfa-fetoprotein levels will be examined over time, and these changes in alfa-fetoprotein rates after 6 months will be examined for each Response category (complete response/ partial response/ stable disease/ progressive disease) and tested using a 1-way ANOVA to see if the change in AFP level differs by response category.
Measured: 6 months
Functional Assessment of Cancer Therapy-General (FACT-G) Item GP5
Participants will answer a single item question from the FACT-G questionnaire "I am bothered by side effects of treatment" Scoring scale of 0 (not at all) to 4 (very much) to assess for side effects to assess for patient rated treatment tolerability.
Measured: At baseline and every 6 weeks up to 6 months
Frequency of Adverse Events - PRO-CTCAE
The frequency and nature of patient-reported symptomatic adverse events will be assessed using 10 items from the PRO-CTCAE item library. PRO-CTCAE items will assess mucositis (2 items; severity, interference), dry mouth (1 item, severity), fatigue (2 items; severity, interference), decreased appetite (2 items; severity, interference), nausea (1 item, severity), and headache (2 items; severity, interference) to measure potential adverse events associated with the study intervention. Participants will select the one response that best describes their experience with a scoring scale(s) of None to Very Severe or Not at all to Very Much.
Measured: At baseline and every 8 weeks up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study startJul 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- THERABIONIC INC.
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Valerie K Pasche, MD, Principal investigator, THERABIONIC INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797884
- Sponsor's protocol ID
- IRB00072592
- Other IDs
- 20231793, R44CA256984
- Acronym
- ARTEMIS
- Status last verified
- Jun 2023
- First submitted
- 10 Mar 2021
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators of this project will make the non-proprietary results and accomplishments of the research plan available to the research community and to the public at large by the timely release and sharing of data. As a means of sharing knowledge, the investigators supported by this grant will seek to publish the original research in primary scientific journals. The investigators will also assert copyright in scientific and technical articles based on data produced under the grant where necessary. For each publication that results from the grant-supported research, we will include an acknowledgment of NIH grant support and follow guidelines regarding free access to published materials. Information on each publication resulting from work performed under the NIH grant supported project will be included in the annual and/or final progress report submitted to the NIH awarding office. Proprietary developments will be protected using intellectual property rights.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Intrabucally Administered Electromagnetic Fields Versus Placebo for Patients With Child-Pugh A or B With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04797884
- Acronym / sponsor ID
- ARTEMIS / IRB00072592
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Child-Pugh A and B
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- THERABIONIC INC.University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 15 Mar 2021 (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.
The primary goals of this study are to compare overall survival and quality of life in subjects with Child-Pugh A or B advanced hepatocellular carcinoma when treated with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Detailed description
Primary Objectives
To compare the overall survival between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare the patient-reported disease-related symptoms between subjects with advanced hepatocellular carcinoma treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Secondary Objectives
To compare progression-free survival between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare safety and tolerability between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare the effect on levels of alpha-fetoprotein between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare global treatment side effect bother between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
To compare patient-rated symptomatic adverse events between subjects treated either with a device emitting radiofrequencies modulated at specific frequencies or with a device emitting unmodulated radiofrequencies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TheraBionic Arm - Active Arm | Experimental | Device: TheraBionic Device, Device: Quality of Life AssessmentFor subjects who are randomized to the active arm, the device will be programmed with hepatocellular carcinoma-specific modulation frequencies and will be activated for >200 one-hour treatment sessions. |
| Placebo Arm | Placebo comparator | Device: Placebo Device, Device: Quality of Life AssessmentFor subjects randomized to the placebo arm, the device will not emit any hepatocellular carcinoma-specific modulation frequencies and will be activated for >200 one-hour treatment sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Biopsy-proven HCC that is locally advanced or metastatic OR
- Patients without biopsy confirmation are also eligible if they meet one of the following criteria:
- For Child-Pugh A participants: treatment failure (defined as documented radiological progression) and/or intolerance to at least two prior treatments with approved or experimental systemic therapies including atezolizumab plus bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, nivolumab plus ipilimumab, pembrolizumab or any other approved or experimental first line and/or second line therapy.
- Child-Pugh B participants are not required to have received any prior treatment.
- Measurable disease according to RECIST v 1.1.
Key exclusion criteria (10 listed)
- Known leptomeningeal disease. (Previously treated, asymptomatic central nervous system (CNS) metastases are eligible).
- Fibrolamellar HCC or combined hepatocellular-cholangiocarcinoma (cHCC-CC).
- Prior treatment with the TheraBionic Device.
- Patients with any of the following within the 12 months prior to registration: uncontrolled/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| TheraBionic DeviceEach treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at one of the recruiting site, all other treatments will be self-administered at the patient's home. | Device | TheraBionic Arm - Active Arm |
| Placebo DeviceEach treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at the recruiting site, all other treatments will be self-administered at the patient's home. | Device | Placebo Arm |
| Quality of Life AssessmentAncillary services | Device | Placebo Arm, TheraBionic Arm - Active Arm |
Primary outcome
Overall Survival
Time frame: Baseline to 6 months
Overall survival assessment will be recorded in days and will represent the period starting at the date of treatment initiation and finishing at the date of patient death. Living patients at the time of analysis will have the date of last contact (consultation visit or phone contact) used to define overall survival.
Quality of Life Survey
Time frame: Baseline to 6 months
Patient-reported hepatobiliary-specific disease-related symptoms will be assessed by the 18-item FACT-Hepatobiliary (Hep) subscale every cycle for the first 6 cycles then every other cycle thereafter, at the end of treatment, and at every 3 months during follow-up.
7 secondary outcomes
Progression-Free Survival
Time frame: Up to 2 years
Proportion of Patients With Disease Control
Time frame: At 4 months and 6 months and up to 2 years
Proportion of Participants That Are Progression Free
Time frame: At 12 weeks, 4 months and 6 months and up to 2 years
Incidences of Adverse Events - CTCAE version 5.0
Time frame: Up to 28 days after study treatment administration or until death
Changes in Alfa-Fetoprotein Levels
Time frame: 6 months
Functional Assessment of Cancer Therapy-General (FACT-G) Item GP5
Time frame: At baseline and every 6 weeks up to 6 months
Frequency of Adverse Events - PRO-CTCAE
Time frame: At baseline and every 8 weeks up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: Yes. The investigators of this project will make the non-proprietary results and accomplishments of the research plan available to the research community and to the public at large by the timely release and sharing of data. As a means of sharing knowledge, the investigators supported by this grant will seek to publish the original research in primary scientific journals. The investigators will also assert copyright in scientific and technical articles based on data produced under the grant where necessary. For each publication that results from the grant-supported research, we will include an acknowledgment of NIH grant support and follow guidelines regarding free access to published materials. Information on each publication resulting from work performed under the NIH grant supported project will be included in the annual and/or final progress report submitted to the NIH awarding office. Proprietary developments will be protected using intellectual property rights.
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Hepatocellular Carcinoma
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.
Valerie K Pasche, MD principal investigator
THERABIONIC INC.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TheraBionic Device and Quality of Life Assessment in people with Hepatocellular Carcinoma, run by THERABIONIC INC. at 7 sites in United States.
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 17 inclusion and 10 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 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Valerie K Pasche, MD (3129610168, valerie.pasche@therabionic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Baseline to 6 months). The study lists 2 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 28 Jun 2023.