HemorrhagePhase 3NCT02227706
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
A Phase 3 study testing EVICEL® Fibrin Sealant and SURGICEL® Absorbable Hemostat in people with Hemorrhage and Soft Tissue Bleeding, run by Ethicon, Inc. at 13 sites in 3 countries.
Trial summary
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Hemorrhage, Soft Tissue Bleeding
- What is being tested?
- EVICEL® Fibrin Sealant and SURGICEL® Absorbable Hemostat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 13 sitesin 3 countries
- Study dates
- 1 Aug 2014to 17 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric subjects birth to <18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to <18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to <1years of age.
- The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study; and
- Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Who cannot join
- Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
- Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
- Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial without prior approval from the Sponsor;
- Subjects who are known, current alcohol and/or drug abusers;
- Subjects admitted for trauma surgery;
- Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
- Subjects with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
- Anastomotic bleeding sites will not be considered for randomization.
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
United Kingdom9 sites
Clinical Investigation Site #21
Birmingham
Clinical Investigation Site #22
Leeds
Clinical Investigation Site #20
Liverpool
Clinical Investigation Site #27
London, SE1 7EH
Clinical Investigation Site #23
London
Clinical Investigation Site #26
London
Clinical Investigation Site #30
Newcastle
Clinical Investigation Site #25
Nottingham, NG7 2UH
Clinical Investigation Site #24
Southampton
Canada3 sites
Clinical Investigation Site #42
Hamilton, Ontario
Clinical Investigation Site #41
Montreal, Quebec
Clinical Investigation Site #40
Toronto, Ontario
About this study
Official title: A Prospective, Randomized, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
Read the detailed description
This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impractical during surgery in paediatric patients.
At least 40 qualified paediatric subjects with an appropriate mild or moderate Target Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.
Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1 years to <18 years of age. When enrolment of the first group is complete; enrolment of a subsequent group will commence and include at least 4 subjects from birth (including neonates ≤37 weeks gestation) to <1 years of age.
Subjects will be followed post-operatively through hospital discharge and at 30 days (±14 days) post-surgery.
- Conditions
- Hemorrhage, Soft Tissue Bleeding
- Being tested
- EVICEL® Fibrin Sealant, SURGICEL® Absorbable Hemostat
- Keywords
- Fibrin Sealant, Hemostatics, Coagulants
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVICEL® Fibrin SealantBiological
Also called EVICEL, fibrin sealant
EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
SURGICEL® Absorbable HemostatDevice
Also called oxidized regenerated cellulose
SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
| Study group | Role | What they receive |
|---|---|---|
| EVICEL® Fibrin Sealant | Experimental | EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product Receives: Biological: EVICEL® Fibrin Sealant |
| SURGICEL® Absorbable Hemostat | Active comparator | SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Receives: Device: SURGICEL® Absorbable Hemostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Time to Haemostasis
Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
Measured: From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Secondary outcomes (16)
Number of Participants Achieving Haemostasis at 4 Minutes
Number of participants achieving haemostasis at target bleeding site at 4 minutes. This endpoint is assessing haemostasis at 4 minutes only and not maintenance of haemostasis following this timepoint. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
Measured: Intra-operatively from randomisation to 4 minutes after randomisation
Number of Participants Achieving Haemostasis at 7 Minutes
Number of Participants Achieving Haemostasis at Target Bleeding Site at 7 Minutes. This endpoint is assessing haemostasis at 7 minutes only and is not affected by haemostasis assessment prior to 7 minutes or maintenance of haemostasis following this 7 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis.
Measured: Intra-operatively from randomisation to 7 minutes after randomisation
Number of Participants Achieving Haemostasis at 10 Minutes
Number of Participants Achieving Haemostasis at Target Bleeding Site at 10 Minutes. This endpoint is assessing haemostasis at 10 minutes only and is not affected by haemostasis assessments prior to 10 minutes or maintenance of haemostasis following this 10 minute assessment. As rebleeding may occur between timepoints, subsequent rebleeding (if any) is detailed in treatment failure analysis).
Measured: Intra-operatively from randomisation to 10 minutes after randomisation
Incidence of Treatment Failures (Number of Participants)
Defined as haemostasis not achieved within 10 minutes or bleeding requiring treatment other than re-application of the assigned haemostatic adjunct within 10 minutes.
Measured: 10 minutes
Estimated Blood Loss
Blood loss during surgical procedure (includes but not limited to the target bleeding site)
Measured: During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Blood Transfusion
Participants requiring a blood transfusion
Measured: From surgical procedure to 30 day (+/-14 day) follow-up visit
Participants Receiving a Blood Transfusion
Details of blood products received (if any)
Measured: From surgery to 30 day (+/-14 day) follow-up visit
Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration
Laboratory parameter changes from baseline to post operative hospital discharge (Haemoglobin and Mean Corpuscular Haemoglobin Concentration)
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Haematocrit
Change in red blood cell proportion in volume in the blood from baseline to post operative hospital discharge
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Platelet Count and White Cell Count
Laboratory parameter changes from baseline to post operative hospital discharge
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)
Changes in Laboratory Parameters Red Blood Cell Count
Laboratory parameter changes from baseline to post operative hospital discharge
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Mean Corpuscular Haemoglobin
Laboratory parameter changes from baseline to post operative hospital discharge
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Mean Corpuscular Volume
Laboratory parameter changes from baseline to post operative hospital discharge
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Laboratory parameter changes in volume from baseline to post operative hospital discharge (Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils)
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time
Laboratory parameter changes from baseline to post operative hospital discharge (Activated Partial Thromboplastin Time and Prothrombin Time)
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters International Normalised Ratio
Standardized measurement of the change in blood clotting time from baseline to post operative hospital discharge
Measured: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study start1 Aug 2014
- Primary completion17 Apr 2019
- Study completion17 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemorrhageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Kocharian, MD, PhD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227706
- Sponsor's protocol ID
- 400-12-006
- Other IDs
- 2013-003401-26
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2014
- Last updated
- 31 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients
- ClinicalTrials.gov ID
- NCT02227706
- Acronym / sponsor ID
- 400-12-006
- Conditions
- Hemorrhage, Soft Tissue Bleeding
- Keywords
- Fibrin Sealant, Hemostatics, Coagulants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 17 Apr 2019 (actual)
- Study completion
- 17 May 2019 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
Detailed description
This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impractical during surgery in paediatric patients.
At least 40 qualified paediatric subjects with an appropriate mild or moderate Target Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.
Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1 years to <18 years of age. When enrolment of the first group is complete; enrolment of a subsequent group will commence and include at least 4 subjects from birth (including neonates ≤37 weeks gestation) to <1 years of age.
Subjects will be followed post-operatively through hospital discharge and at 30 days (±14 days) post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVICEL® Fibrin Sealant | Experimental | Biological: EVICEL® Fibrin SealantEVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product |
| SURGICEL® Absorbable Hemostat | Active comparator | Device: SURGICEL® Absorbable HemostatSURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Paediatric subjects birth to <18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to <18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to <1years of age.
- The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written informed consent for the subject will be acceptable for the subject to be included in the study; and
- Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Key exclusion criteria (8 listed)
- Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
- Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
- Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial without prior approval from the Sponsor;
- Subjects who are known, current alcohol and/or drug abusers;
- Subjects admitted for trauma surgery;
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 |
|---|---|---|
| EVICEL® Fibrin SealantAlso: EVICEL, fibrin sealantEVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product | Biological | EVICEL® Fibrin Sealant |
| SURGICEL® Absorbable HemostatAlso: oxidized regenerated celluloseSURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. | Device | SURGICEL® Absorbable Hemostat |
Primary outcome
Absolute Time to Haemostasis
Time frame: From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Absolute time to haemostasis, defined as absolute time when there was no detectable bleeding at the Target Bleeding Site (TBS).
16 secondary outcomes
Number of Participants Achieving Haemostasis at 4 Minutes
Time frame: Intra-operatively from randomisation to 4 minutes after randomisation
Number of Participants Achieving Haemostasis at 7 Minutes
Time frame: Intra-operatively from randomisation to 7 minutes after randomisation
Number of Participants Achieving Haemostasis at 10 Minutes
Time frame: Intra-operatively from randomisation to 10 minutes after randomisation
Incidence of Treatment Failures (Number of Participants)
Time frame: 10 minutes
Estimated Blood Loss
Time frame: During surgical procedure (first incision to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])
Blood Transfusion
Time frame: From surgical procedure to 30 day (+/-14 day) follow-up visit
Participants Receiving a Blood Transfusion
Time frame: From surgery to 30 day (+/-14 day) follow-up visit
Changes in Laboratory Parameters Haemoglobin and Mean Corpuscular Haemoglobin Concentration
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Haematocrit
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Platelet Count and White Cell Count
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours)
Changes in Laboratory Parameters Red Blood Cell Count
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Mean Corpuscular Haemoglobin
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Mean Corpuscular Volume
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Neutrophils, Lymphocytes, Monocytes, Eosinophils and Basophils
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters Activated Partial Thromboplastin Time and Prothrombin Time
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Changes in Laboratory Parameters International Normalised Ratio
Time frame: Baseline (within 21 days prior to surgery) to Hospital Discharge (within 72 hours of discharge)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Hemorrhage
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
RecruitingObservational study
Heavy Menstrual Bleeding Progestin Treatment in Bleeding Disorders Study
Heavy Menstrual Bleeding, Bleeding Disorder
Not yet recruiting
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm After Subarachnoid Hemorrhage
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.
Richard Kocharian, MD, PhD study director
Ethicon, Inc.
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing EVICEL® Fibrin Sealant and SURGICEL® Absorbable Hemostat in people with Hemorrhage and Soft Tissue Bleeding, run by Ethicon, Inc. at 13 sites in 3 countries.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Canada, Belgium. 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 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?
Yes. Results are posted in the registry (first posted 31 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Absolute Time to Haemostasis (time frame: From randomisation (identification of appropriate target bleeding site) to final fascial closure (median study procedure time 164.0 minutes [range 47.0 - 506.0 minutes])). 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 31 Aug 2020.