Hemophilia APhase 3NCT02172950
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
A Phase 3 study testing rVIII-SingleChain in people with Hemophilia A and Severe Hemophilia A, run by CSL Behring at 64 sites in 25 countries.
Trial summary
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hemophilia A, Severe Hemophilia A
- What is being tested?
- rVIII-SingleChain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 64 sitesin 25 countries
- Study dates
- 13 Oct 2014to 19 Jan 2021
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- PTPs:
- Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
- Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.
- PUPs:
- Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%)
- No prior exposure to any Factor VIII product (with the exception of short-term use of blood products).
- ITI substudy:
- PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.
Who cannot join
- Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
- Currently receiving a therapy not permitted during the study.
- Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase > 5 x upper limit of normal at Screening (if specified)
- Any first-order family (eg, siblings) history of FVIII inhibitors
- For PTPs not rolling over directly from a CSL-sponsored clinical study with rVIII-SingleChain: any history of or current FVIII inhibitors
Trial locations and contacts
64 sites in 25 countries.
64 sites in 25 countries
United States9 sites
Study Site 8400241
Aurora, Colorado, 80045
Study Site 8400184
Chicago, Illinois, 60612
Study Site 8400240
Dallas, Texas, 75390-9016
Study Site 8400118
Hartford, Connecticut, 06106
Study Site 8400041
Houston, Texas, 77030
Study Site 8400116
Miami, Florida, 33136
Study Site 8400154
Milwaukee, Wisconsin, 53226
Study Site 8400204
New Orleans, Louisiana, 70112
Study Site 8400213
San Diego, California, 92103-8651
France5 sites
Study Site 2500015
Brest, 29609
Study Site 2500017
Le Kremlin-Bicêtre, 94270
Study Site 2500028
Lille, 59037
Study Site 2500018
Nantes, 44093
Study Site 2500002
Paris, 75015
Japan5 sites
Study Site 3920031
Hyōgo, 663-8501
Study Site 3920029
Nagoya, 466-8550
Study Site 3920064
Okayama, 710-8602
Study Site 3920033
Saitama, 339-8551
Study Site 3920025
Tokyo, 160-0023
Thailand5 sites
Study Site 7640001
Bangkok, 10330
Study Site 7640005
Bangkok, 10700
Study Site 7640002
Chiang Mai, 50200
Study Site 7640004
Khon Kaen, 40002
Study Site 7640003
Songkhla, 90110
Austria4 sites
Study Site 0400012
Graz, 8036
Study Site 0400003
Linz, 4020
Study Site 0400001
Vienna, 1090
Study Site 0400002
Vienna, 1090
Germany4 sites
Study Site 2760034
Bonn, 53127
Study Site 2760091
Frankfurt, 60596
Study Site 2760087
Giessen, 35385
Study Site 2760066
Hanover, 30625
Poland4 sites
Study Site 6160013
Gdansk, 80-952
Study Site 6160038
Krakow, 31-531
Study Site 6160035
Rzeszów, 35-301
Study Site 6160014
Wroclaw, 50-367
Spain4 sites
Study Site 7240008
A Coruña, 15006
Study Site 7240021
Barcelona, 08035
Study Site 7240007
Madrid, 28046
Study Site 7240023
Valencia, 46026
Australia3 sites
Study Site 0360014
Melbourne, 3052
Study Site 0360028
Nedlands, WA 6009
Study Site 0360031
Perth, WA 6000
Netherlands3 sites
Study Site 5280006
Amsterdam-Zuidoost, 1105 AZ
Study Site 5280008
Nijmegen, 6500
Study Site 5280007
Utrecht, 3584
Philippines2 sites
Study Site 6080001
Cebu City, 6000
Study Site 6080002
Davao City, 8000
Romania2 sites
Study Site 6420030
Bucharest, 011026
Study Site 6420037
Timișoara, 300011
Ukraine2 sites
Study Site 8040007
Dnipropetrovsk, 49102
Study Site 8040005
Lviv, 79044
About this study
Official title: A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.
- Conditions
- Hemophilia A, Severe Hemophilia A
- Being tested
- rVIII-SingleChain
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rVIII-SingleChainBiological
Also called CSL627
Recombinant single-chain coagulation factor VIII
| Study group | Role | What they receive |
|---|---|---|
| Previously treated patients (PTPs) | Experimental | The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available. Receives: Biological: rVIII-SingleChain |
| Previously untreated patients (PUPs) | Experimental | The investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics. Receives: Biological: rVIII-SingleChain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Inhibitor Formation to FVIII in Previously Treated Patients (PTPs) With 100 Exposure Days (EDs) to CSL627
Measured: At the closest visit after 100 EDs (up to 5 years).
Number of Previously Untreated Patients (PUPs) With High-titer Inhibitor Formation to FVIII With at Least 50 EDs to CSL627
High-titer inhibitor is defined as an inhibitor titer of ≥ 5 Bethesda units/mL.
Measured: At the closest visit after 50 EDs (up to 5 years).
Percent Treatment Success for Major Bleeding Episodes in PUPs
Percentage of major bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response". Major bleeding episodes are defined as bleeding episodes for which a subject is required to seek treatment at the hemophilia center or that threatens the subject's life or loss of limb.
Measured: Up to 5 years
Annualized Spontaneous Bleeding Rate in PUPs
The annualized spontaneous bleeding rate for PUPs taking prophylaxis and on-demand treatment regimens.
Measured: Up to 5 years
Secondary outcomes (18)
Percentage of Bleeding Episodes Treated Successfully in PTPs
Percentage of bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response".
Measured: Up to 5 years
Annualized Bleeding Rate in PTPs and PUPs
The annualized bleeding rate for PTPs and PUPs taking prophylaxis and on-demand treatment regimens
Measured: Up to 5 years
Percentage of Bleeding Episodes Requiring 1, 2, 3, or > 3 Injections of CSL627 to Achieve Hemostasis in PTPs and PUPs
Measured: Up to 5 years
Mean Number of On-demand Infusions of CSL627
Measured: Up to 5 years
Mean On-demand Dose Administered of CSL627
Measured: Up to 5 years
Mean Prophylaxis Dose Administered of CSL627
Measured: Up to 5 years
Mean Total Amount of CSL627 Administered During Surgery Period in PTPs
Measured: Day of surgery up to 336 hours post-surgery
Total Amount of CSL627 Administered During Surgery Period in PUPs
Measured: Day of surgery up to 336 hours post-surgery
Hemostatic Efficacy of rVIII-SingleChain for PTPs and PUPs Who Undergo Surgery
The investigator will rate the efficacy of the rVIII-SingleChain treatment during surgery based on a hemostatic efficacy four point rating scale of "excellent, good, moderate or poor/no response".
Measured: From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)
Incidence of Inhibitor Formation to FVIII in PTPs After 10 EDs and After 50 EDs
Measured: Up to 5 years
Percentage of PTPs and PUPs Developing Antibodies Against CSL627
Measured: PTPs: At the closest visit after 100 EDs (up to 5 years). PUPs: At the closest visit after 50 EDs (up to 5 years).
Percentage of PTPs and PUPs Developing Antibodies to Chinese Hamster Ovary (CHO) Proteins
Measured: PTPs: At the closest visit after 100 EDs (up to 5 years). PUPs: At the closest visit after 50 EDs (up to 5 years).
Number of PUPs With High-titer Inhibitor Formation to FVIII After 10 EDs With CSL627
High-titer inhibitor is defined as an inhibitor titer of ≥ 5 Bethesda units/mL.
Measured: At the closest visit after 10 EDs (up to 5 years)
Number of PUPs With Low-titer Inhibitor Formation to FVIII After 10 EDs and After 50 EDs With CSL627
Low-titer inhibitor is defined as an inhibitor titer of less than 5 Bethesda units/mL.
Measured: At the closest visit after 10 and after 50 EDs (up to 5 years)
Incidence of Total Inhibitor Formation to FVIII in PUPs
Measured: Up to 5 years
Percent Treatment Success for Non-major Bleeding Episodes in PUPs
Percentage of bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response". Non-major bleeding episodes are those not requiring treatment at the hemophilia center or not threatening subject's life or loss of limb.
Measured: Up to 5 years
Percentage of PUPs With Clinically Significant Abnormal Vital Signs Values After First Infusion of CSL627
Vital signs assessments include heart rate, blood pressure, and body temperature. Clinical significance of an abnormality will be assessed by the investigator.
Measured: Up to 6 hours after first infusion
Percentage of PUPs With Treatment-emergent Clinically Significant Abnormal Vital Signs Values
Vital signs assessments include heart rate, blood pressure, and body temperature. Clinical significance of an abnormality will be assessed by the investigator.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start13 Oct 2014
- Primary completion19 Jan 2021
- Study completion19 Jan 2021
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 Hemophilia AStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Program Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172950
- Sponsor's protocol ID
- CSL627_3001
- Other IDs
- 2013-003262-13
- Status last verified
- Sep 2021
- First submitted
- 23 Jun 2014
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects With Severe Hemophilia A
- ClinicalTrials.gov ID
- NCT02172950
- Acronym / sponsor ID
- CSL627_3001
- Conditions
- Hemophilia A, Severe Hemophilia A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2014
- Primary completion
- 19 Jan 2021 (actual)
- Study completion
- 19 Jan 2021 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously treated patients (PTPs) | Experimental | Biological: rVIII-SingleChainThe investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule for the subject based upon the subject's pharmacokinetic (PK) profile, rVIII-SingleChain PK data, previous FVIII treatment regimen, and bleeding phenotype, if available. |
| Previously untreated patients (PUPs) | Experimental | Biological: rVIII-SingleChainThe investigator will assign subjects to either prophylaxis or on-demand treatment regimens for rVIII-SingleChain by intravenous injection. The investigator will determine the rVIII-SingleChain dose and dosing schedule at their discretion, taking into consideration the World Federation of Hemophilia (WFH) guidelines, the type of bleeding episode, location of the bleeding, subject's age, and other disease characteristics. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
- Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.
- Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%)
- No prior exposure to any Factor VIII product (with the exception of short-term use of blood products).
- PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.
Key exclusion criteria (5 listed)
- Known or suspected hypersensitivity to rVIII-SingleChain or to any excipients of rVIII-SingleChain or Chinese hamster ovary (CHO) proteins.
- Currently receiving a therapy not permitted during the study.
- Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate aminotransferase > 5 x upper limit of normal at Screening (if specified)
- Any first-order family (eg, siblings) history of FVIII inhibitors
- For PTPs not rolling over directly from a CSL-sponsored clinical study with rVIII-SingleChain: any history of or current FVIII inhibitors
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 |
|---|---|---|
| rVIII-SingleChainAlso: CSL627Recombinant single-chain coagulation factor VIII | Biological | Previously treated patients (PTPs), Previously untreated patients (PUPs) |
Primary outcome
Incidence of Inhibitor Formation to FVIII in Previously Treated Patients (PTPs) With 100 Exposure Days (EDs) to CSL627
Time frame: At the closest visit after 100 EDs (up to 5 years).
Number of Previously Untreated Patients (PUPs) With High-titer Inhibitor Formation to FVIII With at Least 50 EDs to CSL627
Time frame: At the closest visit after 50 EDs (up to 5 years).
High-titer inhibitor is defined as an inhibitor titer of ≥ 5 Bethesda units/mL.
Percent Treatment Success for Major Bleeding Episodes in PUPs
Time frame: Up to 5 years
Percentage of major bleeding episodes treated successfully where treatment success for a bleeding episode is defined as a rating of "excellent" or "good" on the investigator's clinical assessment of hemostatic efficacy 4-point scale "excellent, good, moderate or poor/no response". Major bleeding episodes are defined as bleeding episodes for which a subject is required to seek treatment at the hemophilia center or that threatens the subject's life or loss of limb.
Annualized Spontaneous Bleeding Rate in PUPs
Time frame: Up to 5 years
The annualized spontaneous bleeding rate for PUPs taking prophylaxis and on-demand treatment regimens.
18 secondary outcomes
Percentage of Bleeding Episodes Treated Successfully in PTPs
Time frame: Up to 5 years
Annualized Bleeding Rate in PTPs and PUPs
Time frame: Up to 5 years
Percentage of Bleeding Episodes Requiring 1, 2, 3, or > 3 Injections of CSL627 to Achieve Hemostasis in PTPs and PUPs
Time frame: Up to 5 years
Mean Number of On-demand Infusions of CSL627
Time frame: Up to 5 years
Mean On-demand Dose Administered of CSL627
Time frame: Up to 5 years
Mean Prophylaxis Dose Administered of CSL627
Time frame: Up to 5 years
Mean Total Amount of CSL627 Administered During Surgery Period in PTPs
Time frame: Day of surgery up to 336 hours post-surgery
Total Amount of CSL627 Administered During Surgery Period in PUPs
Time frame: Day of surgery up to 336 hours post-surgery
Hemostatic Efficacy of rVIII-SingleChain for PTPs and PUPs Who Undergo Surgery
Time frame: From the start of surgery through the post-operative recovery (generally up to 14 days after surgery)
Incidence of Inhibitor Formation to FVIII in PTPs After 10 EDs and After 50 EDs
Time frame: Up to 5 years
Percentage of PTPs and PUPs Developing Antibodies Against CSL627
Time frame: PTPs: At the closest visit after 100 EDs (up to 5 years). PUPs: At the closest visit after 50 EDs (up to 5 years).
Percentage of PTPs and PUPs Developing Antibodies to Chinese Hamster Ovary (CHO) Proteins
Time frame: PTPs: At the closest visit after 100 EDs (up to 5 years). PUPs: At the closest visit after 50 EDs (up to 5 years).
Number of PUPs With High-titer Inhibitor Formation to FVIII After 10 EDs With CSL627
Time frame: At the closest visit after 10 EDs (up to 5 years)
Number of PUPs With Low-titer Inhibitor Formation to FVIII After 10 EDs and After 50 EDs With CSL627
Time frame: At the closest visit after 10 and after 50 EDs (up to 5 years)
Incidence of Total Inhibitor Formation to FVIII in PUPs
Time frame: Up to 5 years
Percent Treatment Success for Non-major Bleeding Episodes in PUPs
Time frame: Up to 5 years
Percentage of PUPs With Clinically Significant Abnormal Vital Signs Values After First Infusion of CSL627
Time frame: Up to 6 hours after first infusion
Percentage of PUPs With Treatment-emergent Clinically Significant Abnormal Vital Signs Values
Time frame: Up to 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Program Director study director
CSL Behring
64 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rVIII-SingleChain in people with Hemophilia A and Severe Hemophilia A, run by CSL Behring at 64 sites in 25 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 8 inclusion and 5 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 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, France, Japan, Thailand, Austria and 20 more countries. 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 27 Oct 2021). 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?
Incidence of Inhibitor Formation to FVIII in Previously Treated Patients (PTPs) With 100 Exposure Days (EDs) to CSL627 (time frame: At the closest visit after 100 EDs (up to 5 years).). The study lists 4 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 27 Oct 2021.