HemophiliaJOSEPHANCT03541811
Gait Examination in Patients With Hemophilia in Austria
An observational study of Hemophilia, run by Hochschule Campus Wien (University of Applied Sciences Campus Vienna) at 1 site in Austria.
Trial summary
Hemophilia is an inherited disease caused by deficiency in varying degrees of clotting factors VIII and IX. Depending on the percentage of clotting factor in the blood the disease is categorized as "severe" (<1%, characterized by spontaneous bleedings), "moderate" (1-5%) and "mild" (>5%). Read more about this study
- Who is it for?
- Ages 16 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hemophilia
- What is being tested?
- 3-d gait examination (level walking), Anthropometrics and body composition assessment and Biomarkers
- How many people
- 42 participants
- Where
- 1 siteAustria
- Study dates
- 2 Jul 2018to 1 Jul 2019
- Phase
- Observational
- 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 16 to 49 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Test group population will be recruited at the clinical hemophilia center and pediatric unit of the Medical University of Vienna (patients with hemophila have biannual appointments) Test group participants are asked to invite a friend at the same age (+/- 3 years; between 16 and 45y) to participate in the sense of a peer-matched control
Who may be able to join
- Provide signed and dated informed consent form (additionally from guardian for participants aged under 18 years)
- Willing to comply with all study procedures and be available for the duration of the study
- Diagnosed severe or moderate hemophilia A or B
- Age between 16 and 49 years
- Able to walk without aids or assistance
- Treated with prophylactic substitution, initiated until the age of 18 years
Show all 11Show fewer
- Provide signed and dated informed consent form (additionally from guardian for participants aged under 18 years)
- Willing to comply with all study procedures and be available for the duration of the study
- Male
- Age between 16 and 49 years (no blood samples for participants aged under 18 years)
- Physiological and symmetric gait pattern without using aids or assistance
Who cannot join
- Subjects suffering from functional impairments caused by other conditions than hemophilia
- PWH with joint bleedings within 30 days prior to the examination (applies for test group only)
- PWH treated with immune-tolerance therapy and/or not successfully treated present or past high-titer factor VIII or FIX inhibitor (applies for test group only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Joint-health Outcome Scoring: Exploration in Patients With Hemophilia in Austria (JOSEPHA Phase 1)
Hemophilia is an inherited disease caused by deficiency in varying degrees of clotting factors VIII and IX. Depending on the percentage of clotting factor in the blood the disease is categorized as "severe" (<1%, characterized by spontaneous bleedings), "moderate" (1-5%) and "mild" (>5%). If untreated, recurrent bleeding into the synovial joints often results in irreversible damage due to destruction of the cartilages and progressive joint impairment.
3d-gait analysis has been demonstrated as valid method to assess abnormal gait patterns and to monitor disease progression in patients with hemophilia (PWH). Furthermore, its outcomes facilitate the design of individually tailored therapeutic programs. In contrast to radiological examinations, 3d-gait analyses take place under weight-bearing conditions, which is a relevant issue in terms of weight-induced pain.
Read more
This study aims to explore the applicability of 3-d gait analysis as biomarker (gait deviation index) for functional impairments in PWH. Besides 3-d gait scores, secondary endpoints such as biomarkers reflecting cartilage damage and a laterality-ratio of leg muscle mass (in the case of one-sided target joints) will be tested for their ability to detect functional impairments in young adults with hemophilia.
Based on sample size calculation, 24 subjects aged 16-49 years, able to walk without aids or assistance will be included in each of the two groups: control (healthy, male), PWH (severe or moderate, treated prophylactically). Subjects suffering from functional impairments caused by other conditions than hemophilia, patients with bleedings within 30 days prior to the examination, PWH treated with immune-tolerance therapy and/or not successfully treated present or past high-titer factor VIII or FIX inhibitor will be excluded.
Subjects will pass through a set of examinations (medical history, clinical examination, 3d-gait analysis, anthropometrics, body composition analysis, venipuncture, and urine sampling) and carry an accelerometer device for seven consecutive days.
Confounder adjusted group differences will be assessed by ANCOVA with contrasts and Bonferroni correction. Correlations between the applied examination approaches will be assessed.
An evidence based health promotion program including follow-up examinations, physical activity promotion, and tailored physiotherapy are being envisaged as a follow-up project (JOSEPHA phase 2).
- Conditions
- Hemophilia
- Being tested
- 3-d gait examination (level walking), Anthropometrics and body composition assessment, Biomarkers, Clinical examination, Habitual physical activity tracking (accelerometer based)
- Keywords
- gait, motion capture, hemophilia joint health score, physical activity, body composition, gait deviation index, hemophilia
- Medical subject headings
- Hemophilia A, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-d gait examination (level walking)Diagnostic test
Also called Vicon
Instrumented 3d-gait-analysis will be carried out in the movement lab of the FH (Fachhochschule; University of Applied Sciences) Campus Wien - University of Applied Sciences. The system used is a 10 camera T40S Vicon system with two floor-mounted AMTI OR6/7-2000 force plates. For assessing gait the Plug-in-Gait Lower Body Model with 14 mm retroreflective skin-mounted markers is implemented in the capturing software Vicon Nexus 2.2. The specific parameters will be extracted from the reporting software Vicon Polygon 4.2.
Markers will be placed by one experienced examiner. Subjects will be instructed to walk barefoot on a 10 meters walkway at self-paced walking speed until five right and five left valid first force plate strikes are captured.
Anthropometrics and body composition assessmentDiagnostic test
Body height will be measured with the stadiometer Seca 213 to the next 0.1cm. Body size and weight will be measured without shoes and outerwear. A correction of 1 kg will be subtracted for clothing. Body weight and body composition will be assessed with the medical body composition analyzer Seca mBCA 515 based on bioelectric impedance analysis.
BiomarkersDiagnostic test
Blood will be collected into Vacuette serum-separating tubes and will be kept at room temperature for 30 min. Samples will be centrifuged at 1500g for 10 min and serum aliquots will be stored at 80 C until use. Urine samples will be collected into Vacuette tubes containing no additive from non-fasted individuals between 8:00 and 12:00 a.m. Urine samples will be kept at 4 °C for a maximum of 8 h, and then aliquoted and stored at 80 °C.
All biomarkers (except vitamin D and CRP) will be measured in duplicates using standard enzyme-linked immunosorbent assay (ELISA) kits. Serum samples will be assessed for the level of sCOMP, sC1,2C, and sCS846, IL-6, IL-1, sTNFR1 and sTNFR2. Vitamin D and CRP will be measured using automated immunoassay. In urine samples uCTX-II will be determined and these levels will be corrected for creatinine levels (Jaffé method, in-house validated method).
Clinical examinationDiagnostic test
Hemophilia joint health score (HJHS) will be assessed. Height will be measured with a stadiometer (SECA 213), weight with a medical scale (Marsden M-420) and leg length according to the Plug-in-Gait protocol with a measuring tape from the Anterior Spina Iliaca Superior to the distal aspect of the Medial Malleolus. Further anthropometrical parameters taken will be knee distance and malleoli distance by using a caliper. Gait relevant passive joint ROM of the knee, hip and ankle will be assessed by means of a handheld goniometer. The flexibility of hamstring muscles will be expressed as Popliteal Angle measured with a goniometer with the subjects supine and the hip in 90° flexion.
Habitual physical activity tracking (accelerometer based)Diagnostic test
Also called ActiGraph GT9X Link
Participants will be instructed to wear an Actigraph wGT3X-BT tri-axial accelerometer permanently over a period of seven consecutive days with an elastic band on right hand sided hip. Data will be process with software ActiLife version 6.13. Cut-offs of at least 10 hours daily wear-time and a minimum of three valid weekdays and one valid weekend day will be applied for data cleaning. Count sampling epoch will be set at one minute. The so called Freedson Adult VM2 Cut-Offs will be applied to categorize physical activity intensities. The so called Freedson VM3 Combination will be applied for the estimation of activity energy expenditure.
| Study group | Role | What they receive |
|---|---|---|
| patients with hemophilia (16-45y) | not applicable (no intervention administered) Receives: Diagnostic Test: 3-d gait examination (level walking); Diagnostic Test: Anthropometrics and body composition assessment; Diagnostic Test: Biomarkers; Diagnostic Test: Clinical examination; Diagnostic Test: Habitual physical activity tracking (accelerometer based) | |
| peer-matched healthy control | not applicable (no intervention administered) Receives: Diagnostic Test: 3-d gait examination (level walking); Diagnostic Test: Anthropometrics and body composition assessment; Diagnostic Test: Biomarkers; Diagnostic Test: Clinical examination; Diagnostic Test: Habitual physical activity tracking (accelerometer based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Deviation Index (GDI)
Score expressing overall gait physiology; resulting from 3-d gait analysis [dimensionless]
Measured: May 2018 - Oct 2018 (anticipated)
Secondary outcomes (15)
Kinematic gait parameters
Functional range of motion Hip, Knee, Ankle [°]
Measured: May 2018 - Oct 2018 (anticipated)
Walking velocity
[m sec-1]
Measured: May 2018 - Oct 2018 (anticipated)
Walking cadence
[steps min-1]
Measured: May 2018 - Oct 2018 (anticipated)
Step length
[m]
Measured: May 2018 - Oct 2018 (anticipated)
Stance phase duration
[% gait cycle]
Measured: May 2018 - Oct 2018 (anticipated)
Swing phase duration
[% gait cycle]
Measured: May 2018 - Oct 2018 (anticipated)
Body composition analysis
Bioelectrical impedance derived body fat rate [kg, %], fat-free mass [kg, %]
Measured: May 2018 - Oct 2018 (anticipated)
Biomarkers measured from serum and urine
sCOMP, sC1,2C, sCS846, uCTX-II, Vit D, CRP
Measured: May 2018 - Oct 2018 (anticipated)
Background factors (age)
[years]
Measured: May 2018 - Oct 2018 (anticipated)
Background factors (level of education)
International Standard Classification of Education (ISCED)
Measured: May 2018 - Oct 2018 (anticipated)
Background factors (type and severity of hemophilia)
Type and severity of hemophilia
Measured: May 2018 - Oct 2018 (anticipated)
Background factors (type and history of substitutional therapy )
Type and history of substitutional therapy
Measured: May 2018 - Oct 2018 (anticipated)
Background factors (history of joint bleedings)
annualized bleeding rate
Measured: May 2018 - Oct 2018 (anticipated)
Background factors (inhibitors & immune-tolerance therapy)
Inhibitors \& immune-tolerance therapy history
Measured: May 2018 - Oct 2018 (anticipated)
Hemophilia joint health score (HJHS)
Clinical score [dimensionless]
Measured: May 2018 - Oct 2018 (anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start2 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemophiliaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Vienna, Shire
- Responsible party
- Principal investigator, Peter Putz, Hochschule Campus Wien (University of Applied Sciences Campus Vienna)
- Investigators
- Peter Putz, Dr, Principal investigator, FH Campus Wien, Department Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541811
- Sponsor's protocol ID
- JOSEPHA Phase 1
- Acronym
- JOSEPHA
- Status last verified
- Aug 2019
- First submitted
- 3 Apr 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint-health Outcome Scoring: Exploration in Patients With Hemophilia in Austria (JOSEPHA Phase 1)
- ClinicalTrials.gov ID
- NCT03541811
- Acronym / sponsor ID
- JOSEPHA / JOSEPHA Phase 1
- Conditions
- Hemophilia
- Keywords
- gait, motion capture, hemophilia joint health score, physical activity, body composition, gait deviation index, hemophilia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hochschule Campus Wien (University of Applied Sciences Campus Vienna)University, hospital or other
- Collaborators
- Medical University of Vienna, Shire
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 31 May 2018 (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.
Hemophilia is an inherited disease caused by deficiency in varying degrees of clotting factors VIII and IX. Depending on the percentage of clotting factor in the blood the disease is categorized as "severe" (<1%, characterized by spontaneous bleedings), "moderate" (1-5%) and "mild" (>5%). If untreated, recurrent bleeding into the synovial joints often results in irreversible damage due to destruction of the cartilages and progressive joint impairment.
3d-gait analysis has been demonstrated as valid method to assess abnormal gait patterns and to monitor disease progression in patients with hemophilia (PWH). Furthermore, its outcomes facilitate the design of individually tailored therapeutic programs. In contrast to radiological examinations, 3d-gait analyses take place under weight-bearing conditions, which is a relevant issue in terms of weight-induced pain.
This study aims to explore the applicability of 3-d gait analysis as biomarker (gait deviation index) for functional impairments in PWH. Besides 3-d gait scores, secondary endpoints such as biomarkers reflecting cartilage damage and a laterality-ratio of leg muscle mass (in the case of one-sided target joints) will be tested for their ability to detect functional impairments in young adults with hemophilia.
Based on sample size calculation, 24 subjects aged 16-49 years, able to walk without aids or assistance will be included in each of the two groups: control (healthy, male), PWH (severe or moderate, treated prophylactically). Subjects suffering from functional impairments caused by other conditions than hemophilia, patients with bleedings within 30 days prior to the examination, PWH treated with immune-tolerance therapy and/or not successfully treated present or past high-titer factor VIII or FIX inhibitor will be excluded.
Subjects will pass through a set of examinations (medical history, clinical examination, 3d-gait analysis, anthropometrics, body composition analysis, venipuncture, and urine sampling) and carry an accelerometer device for seven consecutive days.
Confounder adjusted group differences will be assessed by ANCOVA with contrasts and Bonferroni correction. Correlations between the applied examination approaches will be assessed.
An evidence based health promotion program including follow-up examinations, physical activity promotion, and tailored physiotherapy are being envisaged as a follow-up project (JOSEPHA phase 2).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with hemophilia (16-45y) | – | Diagnostic Test: 3-d gait examination (level walking), Diagnostic Test: Anthropometrics and body composition assessment, Diagnostic Test: Biomarkers, Diagnostic Test: Clinical examination, Diagnostic Test: Habitual physical activity tracking (accelerometer based)not applicable (no intervention administered) |
| peer-matched healthy control | – | Diagnostic Test: 3-d gait examination (level walking), Diagnostic Test: Anthropometrics and body composition assessment, Diagnostic Test: Biomarkers, Diagnostic Test: Clinical examination, Diagnostic Test: Habitual physical activity tracking (accelerometer based)not applicable (no intervention administered) |
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Test group population will be recruited at the clinical hemophilia center and pediatric unit of the Medical University of Vienna (patients with hemophila have biannual appointments) Test group participants are asked to invite a friend at the same age (+/- 3 years; between 16 and 45y) to participate in the sense of a peer-matched control
Key inclusion criteria (11 listed)
- Provide signed and dated informed consent form (additionally from guardian for participants aged under 18 years)
- Willing to comply with all study procedures and be available for the duration of the study
- Diagnosed severe or moderate hemophilia A or B
- Age between 16 and 49 years
- Able to walk without aids or assistance
Key exclusion criteria (3 listed)
- Subjects suffering from functional impairments caused by other conditions than hemophilia
- PWH with joint bleedings within 30 days prior to the examination (applies for test group only)
- PWH treated with immune-tolerance therapy and/or not successfully treated present or past high-titer factor VIII or FIX inhibitor (applies for test group only)
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 |
|---|---|---|
| 3-d gait examination (level walking)Also: ViconInstrumented 3d-gait-analysis will be carried out in the movement lab of the FH (Fachhochschule; University of Applied Sciences) Campus Wien - University of Applied Sciences. The system used is a 10 camera T40S Vicon system with two floor-mounted AMTI OR6/7-2000 force plates. For assessing gait the Plug-in-Gait Lower Body Model with 14 mm retroreflective skin-mounted markers is implemented in the capturing software Vicon Nexus 2.2. The specific parameters will be extracted from the reporting software Vicon Polygon 4.2. Markers will be placed by one experienced examiner. Subjects will be instructed to walk barefoot on a 10 meters walkway at self-paced walking speed until five right and five left valid first force plate strikes are captured. | Diagnostic test | patients with hemophilia (16-45y), peer-matched healthy control |
| Anthropometrics and body composition assessmentBody height will be measured with the stadiometer Seca 213 to the next 0.1cm. Body size and weight will be measured without shoes and outerwear. A correction of 1 kg will be subtracted for clothing. Body weight and body composition will be assessed with the medical body composition analyzer Seca mBCA 515 based on bioelectric impedance analysis. | Diagnostic test | patients with hemophilia (16-45y), peer-matched healthy control |
| BiomarkersBlood will be collected into Vacuette serum-separating tubes and will be kept at room temperature for 30 min. Samples will be centrifuged at 1500g for 10 min and serum aliquots will be stored at 80 C until use. Urine samples will be collected into Vacuette tubes containing no additive from non-fasted individuals between 8:00 and 12:00 a.m. Urine samples will be kept at 4 °C for a maximum of 8 h, and then aliquoted and stored at 80 °C. All biomarkers (except vitamin D and CRP) will be measured in duplicates using standard enzyme-linked immunosorbent assay (ELISA) kits. Serum samples will be assessed for the level of sCOMP, sC1,2C, and sCS846, IL-6, IL-1, sTNFR1 and sTNFR2. Vitamin D and CRP will be measured using automated immunoassay. In urine samples uCTX-II will be determined and these levels will be corrected for creatinine levels (Jaffé method, in-house validated method). | Diagnostic test | patients with hemophilia (16-45y), peer-matched healthy control |
| Clinical examinationHemophilia joint health score (HJHS) will be assessed. Height will be measured with a stadiometer (SECA 213), weight with a medical scale (Marsden M-420) and leg length according to the Plug-in-Gait protocol with a measuring tape from the Anterior Spina Iliaca Superior to the distal aspect of the Medial Malleolus. Further anthropometrical parameters taken will be knee distance and malleoli distance by using a caliper. Gait relevant passive joint ROM of the knee, hip and ankle will be assessed by means of a handheld goniometer. The flexibility of hamstring muscles will be expressed as Popliteal Angle measured with a goniometer with the subjects supine and the hip in 90° flexion. | Diagnostic test | patients with hemophilia (16-45y), peer-matched healthy control |
| Habitual physical activity tracking (accelerometer based)Also: ActiGraph GT9X LinkParticipants will be instructed to wear an Actigraph wGT3X-BT tri-axial accelerometer permanently over a period of seven consecutive days with an elastic band on right hand sided hip. Data will be process with software ActiLife version 6.13. Cut-offs of at least 10 hours daily wear-time and a minimum of three valid weekdays and one valid weekend day will be applied for data cleaning. Count sampling epoch will be set at one minute. The so called Freedson Adult VM2 Cut-Offs will be applied to categorize physical activity intensities. The so called Freedson VM3 Combination will be applied for the estimation of activity energy expenditure. | Diagnostic test | patients with hemophilia (16-45y), peer-matched healthy control |
Primary outcome
Gait Deviation Index (GDI)
Time frame: May 2018 - Oct 2018 (anticipated)
Score expressing overall gait physiology; resulting from 3-d gait analysis [dimensionless]
15 secondary outcomes
Kinematic gait parameters
Time frame: May 2018 - Oct 2018 (anticipated)
Walking velocity
Time frame: May 2018 - Oct 2018 (anticipated)
Walking cadence
Time frame: May 2018 - Oct 2018 (anticipated)
Step length
Time frame: May 2018 - Oct 2018 (anticipated)
Stance phase duration
Time frame: May 2018 - Oct 2018 (anticipated)
Swing phase duration
Time frame: May 2018 - Oct 2018 (anticipated)
Body composition analysis
Time frame: May 2018 - Oct 2018 (anticipated)
Biomarkers measured from serum and urine
Time frame: May 2018 - Oct 2018 (anticipated)
Background factors (age)
Time frame: May 2018 - Oct 2018 (anticipated)
Background factors (level of education)
Time frame: May 2018 - Oct 2018 (anticipated)
Background factors (type and severity of hemophilia)
Time frame: May 2018 - Oct 2018 (anticipated)
Background factors (type and history of substitutional therapy )
Time frame: May 2018 - Oct 2018 (anticipated)
Background factors (history of joint bleedings)
Time frame: May 2018 - Oct 2018 (anticipated)
Background factors (inhibitors & immune-tolerance therapy)
Time frame: May 2018 - Oct 2018 (anticipated)
Hemophilia joint health score (HJHS)
Time frame: May 2018 - Oct 2018 (anticipated)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 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.
Peter Putz, Dr principal investigator
FH Campus Wien, Department Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia, run by Hochschule Campus Wien (University of Applied Sciences Campus Vienna) at 1 site in Austria.
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 11 inclusion and 3 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 7 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 Austria. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gait Deviation Index (GDI) (time frame: May 2018 - Oct 2018 (anticipated)). 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 7 Aug 2019.