Gaucher Disease, Type 3Phase 2/3NCT05815004
An Efficacy and Safety Study of AVR-RD-02 Compared to Enzyme Replacement Therapy for Treatment of Gaucher Disease Type 3
A Phase 2/3 study testing Gene therapy and Enzyme Replacement Agent in people with Gaucher Disease, Type 3, run by AVROBIO.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of autologous hemotopoietic stem cell (HSC) gene therapy, AVR-RD-02, compared to enzyme replacement therapy, for the treatment of Gaucher disease Type 3 in male and female participants aged 2 to 25 years. Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Gaucher Disease, Type 3
- What is being tested?
- Gene therapy and Enzyme Replacement Agent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2027
- 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 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participant and/or parent, caregiver, or legal representative must be willing and able to provide written informed consent/assent for the study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures, including the use of any data collection device(s) that may be used to directly record participant data.
- Participant is ≥2 to ≤ 25 years old, at the time of providing informed consent or assent.
- Participant has a confirmed diagnosis of Gaucher disease Type 3 based on all of the following:
- Biallelic GBA1 gene mutation
- Deficient GCase enzyme activity in blood
- Clinical phenotype with the presence of gaze palsy, predominantly horizontal and with slow or absent saccades
Show all 19Show fewer
- Participant has the presence of one or both of the following within 3 months of screening:
- Ataxia (score ≥1) based on the modified scale for the assessment and rating of ataxia total score (mSARA)
- Interstitial lung disease (to be confirmed by radiological imaging)
- Participant has the presence of one or both of the following within 3 months of screening:
- Hepatomegaly
- Splenomegaly
- Participant is on stable prescribed ERT dose for ≥6 consecutive months at the time of Screening.
- Participant has not received SRT or chaperone therapy for Gaucher disease during the 6 months immediately preceding Screening.
- Participant is willing to attend all study visits and comply with all study procedures and assessments.
- Participant is willing to comply with the contraceptive and reproductive requirements.
- Male and female participants must agree to refrain from donating sperm and eggs, respectively, after undergoing conditioning.
- Participant must be willing to refrain from donating blood, organs, tissues, or cells for gene therapy infusion any time after AVR-RD-02 treatment.
- Participant must be willing to receive blood or blood products transfusion to manage AEs as required.
Who cannot join
- Participant has a diagnosis of Gaucher disease Type 1 or Type 2.
- Participant has any one of the following:
- Hemoglobin value of <9.0 g/dL
- Platelet count of <70 × 109/L
- Pulmonary hypertension
- Bone crisis attributable to osteonecrosis and/or pathological fractures within 3 months prior to Screening
Show all 29Show fewer
- Treatment refractory epilepsy
- Progressive myoclonic epilepsy
- Participant has had or is scheduled to undergo a partial or total splenectomy.
- Participant requires use of invasive ventilatory support.
- Participant requires use of noninvasive ventilator support while awake for longer than 12 hours daily.
- Participant has a contraindication to ERT, including a prior anaphylactic or anaphylactoid reaction of any severity to ERT.
- Busulfan is contraindicated for the participant.
- Participant has a history of sensitivity to dimethyl sulfoxide.
- Participant presents with iron, folic acid, and/or vitamin B12 deficiency anemia during Screening.
- Participant has idiopathic thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), thrombocytopenia, anemia, hepatomegaly, splenomegaly, and/or osteoporosis, unrelated to Gaucher disease.
- Participant has a clinical comorbidity, such as neurologic, cardiovascular, pulmonary, hepatic, gastrointestinal, renal, hematologic, endocrine, metabolic, genetic, immunologic, neoplastic, or psychiatric disease, other medical condition(s), or intercurrent illnesses that may confound the study results or may preclude participation in the study.
- Participant has a prior or current history of cancer. The one exception is a history of resected squamous cell carcinoma.
- Participant has any other medical condition that predisposes him/her to (or conveys increased risk of) malignancy, in the opinion of the Investigator.
- Participant has undergone, or is scheduled to undergo, bone marrow, HSC, and/or solid organ transplant.
- NOTE: Participants who are otherwise eligible for the study but are scheduled for bone marrow transplant or HSC infusion to treat Gaucher disease Type 3 may be enrolled in the study (instead of receiving an allogeneic transplant) and undergo autologous HSC gene therapy with AVR-RD-02.
- Participant has clinically significant immunosuppressive disease or condition at Screening.
- Participant is on (or requires treatment with) cytotoxic or immunosuppressive agents from 60 days prior to signing informed consent at Screening (i.e., study enrollment) through the Week 52 study visit; the one exception is treatment with agents required per protocol for autologous HSC infusion.
- Participant is on (or requires treatment with) red blood cell growth factor (e.g., erythropoietin) from 6 months prior to enrollment (i.e., signing of informed consent at Screening) through the Week 52 study visit.
- Participant has any condition that makes it impossible to perform magnetic resonance imaging (MRI) studies (including allergies to anesthetics or contrast agents).
- Participant has medical conditions(s) and/or is receiving medication(s) that would contraindicate ability to undergo mobilization (including contraindication to granulocyte colony stimulating factor [G-CSF] and/or plerixafor), apheresis, or conditioning.
- Participant has previously received treatment with AVR-RD-02 or any other gene therapy.
- Participation in (or plan to participate in) any other investigational drug study or plan to be exposed to any other investigational agent, device, and/or procedure from 30 days prior to enrollment (i.e., signing of informed consent at Screening) through study completion.
- Participant is not suitable for participation as judged by the Investigator, for any reason, including medical or clinical conditions or potential risk of noncompliance to study procedures.
About this study
Official title: Guard3: An Open-label, Parallel-arm, Randomized, Controlled, Phase 2/Phase 3 Study Evaluating the Efficacy and Safety of Autologous HSC Gene Therapy, AVR-RD-02, Compared to ERT for Gaucher Disease Type 3 in Participants Aged 2 to 25
The purpose of this study is to evaluate the efficacy and safety of autologous hemotopoietic stem cell (HSC) gene therapy, AVR-RD-02, compared to enzyme replacement therapy, for the treatment of Gaucher disease Type 3 in male and female participants aged 2 to 25 years.
The study will consist of 2 parts - Core (Part 1) followed by the ERT-crossover (Part 2)
Read the detailed description
Core (Part 1)
Once a participant consents, he/she will complete the screening period within 30 days.
Eligible participants will have baseline assessments completed 30 days later and then will be randomized into one of two treatment arms: AVR-RD-02 arm or ERT control arm.
If randomized to the AVR-RD-02 arm, the participant will enter the pre-gene therapy infusion period (approximately 15 weeks), which consists of mobilization, apheresis, AVR-RD-02 preparation and testing for release, discontinuation of ERT, and conditioning. The participant will then receive the AVR-RD-02 gene therapy (1 day) followed by a 52-week follow-up period in which periodic safety and efficacy assessments will be performed. Participants will not receive ERT after gene therapy infusion unless indicated by pre-specified laboratory and clinical criteria.
If randomized to the ERT Control arm, the participant will remain on their prescribed ERT regimen for 52-week observation period with approximately 4 study visits during this time.
ERT-crossover (Part 2)
After 52 weeks of observation in Part 1, participants in the ERT Control Arm will have the opportunity to enter Part 2 and receive AVR-RD-02. They will start with baseline assessments and follow a similar schedule to the schedule followed by participants assigned to AVR-RD-02 in the Core Study (Part 1).
- Conditions
- Gaucher Disease, Type 3
- Being tested
- Gene therapy, Enzyme Replacement Agent
- Keywords
- Gaucher Disease, Gaucher Disease, Type 3, Neuronopathic Gaucher Disease, GD3
- Medical subject headings
- Gaucher Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene therapyDrug
Also called AVR-RD-02
AVR-RD-02 Drug product: active substance is autologous CD34+ enriched hematopoietic stem cells (HSCs) that have been genetically modified ex vivo with a lentiviral vector (LV) to contain a ribonucleic acid (RNA) transcript that, after reverse transcription, results in codon-optimized, complementary deoxyribonucleic acid (cDNA) that, upon its integration into human genome, encodes for functional human glucocerebrosidase (GCase)
Enzyme Replacement AgentDrug
Also called Imiglucerase, velaglucerase, taliglucerase alfa
A hydrolytic lysosomal glucocerebrosidase-specific enzyme
| Study group | Role | What they receive |
|---|---|---|
| AVR-RD-02 Arm | Experimental | Participants will have been on a stable prescribed ERT dose for at least 6 consecutive months at the time of Screening and willing to remain on the same ERT dose until 2 weeks prior to gene therapy infusion. Receives: Drug: Gene therapy |
| ERT Control Arm | Active comparator | Participants on stable prescribed ERT dose for at least 6 consecutive months at the time of Screening.
Participants will have the opportunity to receive a gene therapy infusion of AVR-RD-02 after week 52 of Part 1. Receives: Drug: Gene therapy; Drug: Enzyme Replacement Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in a multidomain endpoint as assessed by Global Statistical Test (GST)
The multidomain endpoint consists of the following 4 domains:
- Change in modified Scale for Assessment and Rating of Ataxia total score (mSARA)
II. Percent change in diffusing capacity of the lung for carbon monoxide (DLco) for the assessment of interstitial lung disease (ILD)
III. Percent change in spleen volume by Magnetic Resonance Imaging (MRI)
IV. Percent change in a liver volume by MRI
Measured: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
Secondary outcomes (10)
Change from Baseline in Lyso-Gb1 level in cerebrospinal fluid (CSF) as assessed by liquid chromatography tandem mass spectrometry (LC/MS/MS)
Measured: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
Change from baseline in clinical improvement as assessed by Clinical Global Impression -Improvement (CGI-I scale)
Measured: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
Change from baseline in pain as assessed by Brief Pain Inventory-Short Form (BPI-SF) questionnaire scores
Measured: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
Vector Copy Number (VCN) - Engraftment of genetically-modified hematopoietic stem cells (HSCs) in peripheral blood leukocytes (PBL) as assessed by droplet digital polymerase chain reaction (ddPCR)
Measured: Baseline to 52 weeks post AVR-RD-02 infusion
Vector Copy Number (VCN) - Engraftment of genetically-modified hematopoietic stem cells (HSCs) in bone marrow as assessed by digital droplet polymerase chain reaction (ddPCR)
Measured: Baseline to 52 weeks post AVR-RD-02 infusion
Incidence of clinically significant AEs and SAEs
Measured: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by clinical laboratory tests
Measured: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by vital signs
Measured: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by electrocardiograms (ECGs)
Measured: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by physical examinations findings
Measured: Baseline to 52 weeks post AVR-RD-02 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Further development of programs halted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gaucher Disease, Type 3Studies 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
- Model description
- Participants, who are randomized to the ERT control arm, will have the opportunity to cross over and receive AVR-RD-02 gene therapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVROBIO
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Milena Veselinovic, MD, PhD, Study director, AVROBIO, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815004
- Sponsor's protocol ID
- AVRO-RD-02-301
- Status last verified
- Aug 2023
- First submitted
- 3 Apr 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guard3: An Open-label, Parallel-arm, Randomized, Controlled, Phase 2/Phase 3 Study Evaluating the Efficacy and Safety of Autologous HSC Gene Therapy, AVR-RD-02, Compared to ERT for Gaucher Disease Type 3 in Participants Aged 2 to 25
- ClinicalTrials.gov ID
- NCT05815004
- Acronym / sponsor ID
- AVRO-RD-02-301
- Conditions
- Gaucher Disease, Type 3
- Keywords
- Gaucher Disease, Gaucher Disease, Type 3, Neuronopathic Gaucher Disease, GD3
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Further development of programs halted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AVROBIOIndustry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Apr 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.
The purpose of this study is to evaluate the efficacy and safety of autologous hemotopoietic stem cell (HSC) gene therapy, AVR-RD-02, compared to enzyme replacement therapy, for the treatment of Gaucher disease Type 3 in male and female participants aged 2 to 25 years.
The study will consist of 2 parts - Core (Part 1) followed by the ERT-crossover (Part 2)
Detailed description
Core (Part 1)
Once a participant consents, he/she will complete the screening period within 30 days.
Eligible participants will have baseline assessments completed 30 days later and then will be randomized into one of two treatment arms: AVR-RD-02 arm or ERT control arm.
If randomized to the AVR-RD-02 arm, the participant will enter the pre-gene therapy infusion period (approximately 15 weeks), which consists of mobilization, apheresis, AVR-RD-02 preparation and testing for release, discontinuation of ERT, and conditioning. The participant will then receive the AVR-RD-02 gene therapy (1 day) followed by a 52-week follow-up period in which periodic safety and efficacy assessments will be performed. Participants will not receive ERT after gene therapy infusion unless indicated by pre-specified laboratory and clinical criteria.
If randomized to the ERT Control arm, the participant will remain on their prescribed ERT regimen for 52-week observation period with approximately 4 study visits during this time.
ERT-crossover (Part 2)
After 52 weeks of observation in Part 1, participants in the ERT Control Arm will have the opportunity to enter Part 2 and receive AVR-RD-02. They will start with baseline assessments and follow a similar schedule to the schedule followed by participants assigned to AVR-RD-02 in the Core Study (Part 1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants, who are randomized to the ERT control arm, will have the opportunity to cross over and receive AVR-RD-02 gene therapy.
| Arm | Type | Receives |
|---|---|---|
| AVR-RD-02 Arm | Experimental | Drug: Gene therapyParticipants will have been on a stable prescribed ERT dose for at least 6 consecutive months at the time of Screening and willing to remain on the same ERT dose until 2 weeks prior to gene therapy infusion. |
| ERT Control Arm | Active comparator | Drug: Gene therapy, Drug: Enzyme Replacement AgentParticipants on stable prescribed ERT dose for at least 6 consecutive months at the time of Screening. Participants will have the opportunity to receive a gene therapy infusion of AVR-RD-02 after week 52 of Part 1. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Participant and/or parent, caregiver, or legal representative must be willing and able to provide written informed consent/assent for the study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures, including the use of any data collection device(s) that may be used to directly record participant data.
- Participant is ≥2 to ≤ 25 years old, at the time of providing informed consent or assent.
- Participant has a confirmed diagnosis of Gaucher disease Type 3 based on all of the following:
- Participant has the presence of one or both of the following within 3 months of screening:
- Participant has the presence of one or both of the following within 3 months of screening:
Key exclusion criteria (29 listed)
- Participant has a diagnosis of Gaucher disease Type 1 or Type 2.
- Participant has any one of the following:
- Participant has had or is scheduled to undergo a partial or total splenectomy.
- Participant requires use of invasive ventilatory support.
- Participant requires use of noninvasive ventilator support while awake for longer than 12 hours daily.
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 |
|---|---|---|
| Gene therapyAlso: AVR-RD-02AVR-RD-02 Drug product: active substance is autologous CD34+ enriched hematopoietic stem cells (HSCs) that have been genetically modified ex vivo with a lentiviral vector (LV) to contain a ribonucleic acid (RNA) transcript that, after reverse transcription, results in codon-optimized, complementary deoxyribonucleic acid (cDNA) that, upon its integration into human genome, encodes for functional human glucocerebrosidase (GCase) | Drug | AVR-RD-02 Arm, ERT Control Arm |
| Enzyme Replacement AgentAlso: Imiglucerase, velaglucerase, taliglucerase alfaA hydrolytic lysosomal glucocerebrosidase-specific enzyme | Drug | ERT Control Arm |
Primary outcome
Change from baseline in a multidomain endpoint as assessed by Global Statistical Test (GST)
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
The multidomain endpoint consists of the following 4 domains: I. Change in modified Scale for Assessment and Rating of Ataxia total score (mSARA) II. Percent change in diffusing capacity of the lung for carbon monoxide (DLco) for the assessment of interstitial lung disease (ILD) III. Percent change in spleen volume by Magnetic Resonance Imaging (MRI) IV. Percent change in a liver volume by MRI
10 secondary outcomes
Change from Baseline in Lyso-Gb1 level in cerebrospinal fluid (CSF) as assessed by liquid chromatography tandem mass spectrometry (LC/MS/MS)
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
Change from baseline in clinical improvement as assessed by Clinical Global Impression -Improvement (CGI-I scale)
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
Change from baseline in pain as assessed by Brief Pain Inventory-Short Form (BPI-SF) questionnaire scores
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)
Vector Copy Number (VCN) - Engraftment of genetically-modified hematopoietic stem cells (HSCs) in peripheral blood leukocytes (PBL) as assessed by droplet digital polymerase chain reaction (ddPCR)
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion
Vector Copy Number (VCN) - Engraftment of genetically-modified hematopoietic stem cells (HSCs) in bone marrow as assessed by digital droplet polymerase chain reaction (ddPCR)
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion
Incidence of clinically significant AEs and SAEs
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by clinical laboratory tests
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by vital signs
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by electrocardiograms (ECGs)
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion
Number of participants with clinically relevant abnormalities as assessed by physical examinations findings
Time frame: Baseline to 52 weeks post AVR-RD-02 infusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Yes
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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.
Milena Veselinovic, MD, PhD study director
AVROBIO, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gene therapy and Enzyme Replacement Agent in people with Gaucher Disease, Type 3, run by AVROBIO.
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 19 inclusion and 29 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: withdrawn, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 from baseline in a multidomain endpoint as assessed by Global Statistical Test (GST) (time frame: Baseline to 52 weeks post AVR-RD-02 infusion (AVR-RD-02 arm) or Baseline to 52 weeks (ERT arm)). 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 2023.