Congenital Heart Disease With Fontan CirculationPhase 3RUBATO OLNCT03775421
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
A Phase 3 study testing macitentan 10 mg in people with Congenital Heart Disease With Fontan Circulation, run by Actelion at 19 sites in 11 countries.
Trial summary
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Congenital Heart Disease With Fontan Circulation
- What is being tested?
- macitentan 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 19 sitesin 11 countries
- Study dates
- 11 Apr 2019to 18 Jan 2022
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures.
- Subjects who have completed Week 52 of the parent AC-055H301/RUBATO DB study (NCT03153137)
- Women of childbearing potential must:
- have a negative serum pregnancy test prior to first intake of OL study drug, and,
- agree to perform monthly pregnancy tests up to the end of the safety follow up (S-FU) period, and,
- use reliable methods of contraception from enrollment up to at least 30 days after study treatment discontinuation.
Who cannot join
- Clinical worsening leading to medical interventions including reoperation of Fontan circulation (Fontan take-down) during the enrollment period
- Systolic blood pressure < 90 mmHg (< 85 mmHg for subjects < 18 years old and < 150 cm of height) at rest
- Criteria related to macitentan use
- Any known factor or disease that may interfere with treatment compliance or full participation in the study
Trial locations and contacts
19 sites in 11 countries.
19 sites in 11 countries
Australia4 sites
Royal Adelaide Hospital
Adelaide, 5000
Royal Prince Alfred Hospital
Camperdown, 2050
The Prince Charles Hospital, Adult Congenital Heart Disease Unit
Chermside, 4032
Royal Children's Hospital
Parkville, 3052
Poland3 sites
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Krakowski Szpital Specjalityczny im. Jana Pawla II, Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, 31-202
Wojewodzki Szpital Specjalistyczny We Wroclawiu
Wroclaw, 51-124
United States2 sites
Massachusetts General Hospital Heart Center
Boston, Massachusetts, 02114
Providence Medical Research Providence Health Care
Spokane, Washington, 99202
China2 sites
Beijing Anzhen Hospital
Beijing, 100029
Shanghai Children's Medical Center
Shanghai, 200127
France2 sites
Hôpital Necker - Enfants Malades
Paris, 75015
Hôpital Cardiologique Du Haut-Lévêque
Pessac, 33604
About this study
Official title: Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.
- Being tested
- macitentan 10 mg
- Keywords
- Congenital Heart Failure, macitentan, Univentricular Heart, Cavopulmonary Anastomosis, Fontan circulation
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macitentan 10 mgDrug
macitentan 10 mg, film-coated tablet, oral use
| Study group | Role | What they receive |
|---|---|---|
| Open-label treatment period | Experimental | oral administration of 10 mg macitentan once daily Receives: Drug: macitentan 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after end of treatment (EOT) (limits included) within the analysis set was considered to be treatment-emergent.
Measured: Up to 133 weeks
Number of Participants With Treatment-emergent Serious AEs (TESAEs)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any SAE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be TESAEs.
Measured: Up to 133 weeks
Number of Participants With TEAEs Leading to Death
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be treatment-emergent.
Measured: Up to 133 weeks
Number of Participants With TEAEs Leading to Premature Discontinuation of Study Treatment
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be treatment-emergent.
Measured: Up to 133 weeks
Number of Participants With Treatment-emergent Marked Laboratory Abnormalities up to 30 Days After Study Treatment Discontinuation
Number of participants with treatment-emergent marked laboratory abnormalities (Hemoglobin [gram/Liter {g/L}], Platelets [giga/L {10^9 cells/L}], Leukocytes [10^9 cells/L], Lymphocytes [10^9 cells/L], Neutrophils [10^9 cells/L], Prothrombin International Normalized Ratio [PINR;Ratio], Aspartate Aminotransferase [Units/L {U/L}], Bilirubin [micromoles/L {mcmol/L}], Alkaline Phosphatase [U/L], Glomerular Filtration Rate [milliliter/minute/1.73 meter square], Glucose [millimoles/L {mmol/L}], Potassium [mmol/L], Sodium [mmol/L], Triglycerides [mmol/L] were reported. Abnormalities that occurred after study treatment start and up to 30 days after study treatment discontinuation, that were not present at baseline, were treatment-emergent. Marked laboratory abnormalities reported for at least 1 participant were reported in this outcome measure. >=:greater than or equal to; >:greater than; <:less than; ULN: upper limit of normal; L:Low, H:High, LLL:lower/worse than LL, HHH:higher/worse than HH.
Measured: Up to 133 weeks
Change From Baseline in Hemoglobin Over Time
Change from baseline in hemoglobin over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Hematocrit Over Time
Change from baseline in hematocrit over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Leukocytes, Neutrophils, Lymphocytes, and Platelets Over Time
Change from baseline in leukocytes, neutrophils, lymphocytes, and platelets over time were reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP) Over Time
Change from baseline in systolic and diastolic arterial BP over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Pulse Rate Over Time
Change from baseline in pulse rate over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Peripheral Oxygen Saturation (SpO2) Over Time
Change from baseline in SpO2 over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Body Weight Over Time
Change from baseline in body weight over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl Transferase (GGT) Over Time
Change from baseline in ALT, AST, AP, and GGT over time were reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Bilirubin, Direct Bilirubin, and Creatinine Over Time
Change from baseline in bilirubin, direct bilirubin, and creatinine over time were reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Glomerular Filtration Rate (GFR) Over Time
Change from baseline in GFR over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Prothrombin Time Over Time
Change from baseline in prothrombin time over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Change From Baseline in Prothrombin International Normalized Ratio Over Time
Change from baseline in prothrombin international normalized ratio over time was reported in this outcome measure.
Measured: Baseline up to Week 130
Secondary outcomes (2)
Change From Baseline in Peak Oxygen Uptake/Consumption (VO2)
Change from baseline in peak VO2 was reported in this outcome measure.
Measured: Baseline, Week 52, and Week 104
Change From Baseline in Mean Count Per Minute of Daily Physical Activity Measured by Accelerometer (PA-Ac)
Change from baseline in mean count per minute of daily PA-Ac was reported in this outcome measure.
Measured: Baseline, Week 26, Week 52, Week 78, and Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start11 Apr 2019
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Why it stopped: As The RUBATO DB study (NCT03153137) did not show any benefit of treatment with macitentan in Fontan-palliated participants, the sponsor has decided to terminate the RUBATO OL study (NCT03775421). No new safety observations were made.
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 Congenital Heart Disease With Fontan CirculationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- The study is designed as an open-label (OL), single-arm, multicenter long-term trial in which all adolescent (≥ 12 years) and adult male and female subjects who had previously completed in the parent RUBATO DB study (AC-055H301, NCT03153137) will enroll. The primary objective of the study is to assess the long-term safety and tolerability of macitentan. All efficacy endpoints including the ones listed below are considered as exploratory in nature.
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance, Henry Ford Health System, Almac Clinical Technologies, ActiGraph LLC, Medidata Solutions
- Responsible party
- Sponsor
- Investigators
- Thierry Francis Briand, MD, Study director, Actelion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775421
- Sponsor's protocol ID
- AC-055H302
- Other IDs
- 2018-002821-45, 2018
- Acronym
- RUBATO OL
- Status last verified
- Mar 2023
- First submitted
- 21 Nov 2018
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Single-arm, Open-label Long-term Study Assessing the Safety, Tolerability, and Effectiveness of Macitentan in Fontan-palliated Adult and Adolescent Subjects
- ClinicalTrials.gov ID
- NCT03775421
- Acronym / sponsor ID
- RUBATO OL / AC-055H302
- Keywords
- Congenital Heart Failure, macitentan, Univentricular Heart, Cavopulmonary Anastomosis, Fontan circulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: As The RUBATO DB study (NCT03153137) did not show any benefit of treatment with macitentan in Fontan-palliated participants, the sponsor has decided to terminate the RUBATO OL study (NCT03775421). No new safety observations were made.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Collaborators
- Covance, Henry Ford Health System, Almac Clinical Technologies, ActiGraph LLC, Medidata Solutions
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study (AC-055H301, NCT03153137). This OL trial studies the long-term effect of macitentan in Fontan-palliated patients as it is not known if the effect of macitentan is sustained beyond 52 weeks (end of the parent RUBATO DB study). In addition, the trial also studies the long-term safety of macitentan as this is also unknown. Furthermore, the opportunity will be given to patients who were on placebo in the parent RUBATO DB study to receive macitentan 10 mg and benefit from a potentially active treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is designed as an open-label (OL), single-arm, multicenter long-term trial in which all adolescent (≥ 12 years) and adult male and female subjects who had previously completed in the parent RUBATO DB study (AC-055H301, NCT03153137) will enroll. The primary objective of the study is to assess the long-term safety and tolerability of macitentan. All efficacy endpoints including the ones listed below are considered as exploratory in nature.
| Arm | Type | Receives |
|---|---|---|
| Open-label treatment period | Experimental | Drug: macitentan 10 mgoral administration of 10 mg macitentan once daily |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures.
- Subjects who have completed Week 52 of the parent AC-055H301/RUBATO DB study (NCT03153137)
- Women of childbearing potential must:
Key exclusion criteria (4 listed)
- Clinical worsening leading to medical interventions including reoperation of Fontan circulation (Fontan take-down) during the enrollment period
- Systolic blood pressure < 90 mmHg (< 85 mmHg for subjects < 18 years old and < 150 cm of height) at rest
- Criteria related to macitentan use
- Any known factor or disease that may interfere with treatment compliance or full participation in the study
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 |
|---|---|---|
| macitentan 10 mgmacitentan 10 mg, film-coated tablet, oral use | Drug | Open-label treatment period |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 133 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after end of treatment (EOT) (limits included) within the analysis set was considered to be treatment-emergent.
Number of Participants With Treatment-emergent Serious AEs (TESAEs)
Time frame: Up to 133 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any SAE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be TESAEs.
Number of Participants With TEAEs Leading to Death
Time frame: Up to 133 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be treatment-emergent.
Number of Participants With TEAEs Leading to Premature Discontinuation of Study Treatment
Time frame: Up to 133 weeks
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be treatment-emergent.
Number of Participants With Treatment-emergent Marked Laboratory Abnormalities up to 30 Days After Study Treatment Discontinuation
Time frame: Up to 133 weeks
Number of participants with treatment-emergent marked laboratory abnormalities (Hemoglobin [gram/Liter {g/L}], Platelets [giga/L {10^9 cells/L}], Leukocytes [10^9 cells/L], Lymphocytes [10^9 cells/L], Neutrophils [10^9 cells/L], Prothrombin International Normalized Ratio [PINR;Ratio], Aspartate Aminotransferase [Units/L {U/L}], Bilirubin [micromoles/L {mcmol/L}], Alkaline Phosphatase [U/L], Glomerular Filtration Rate [milliliter/minute/1.73 meter square], Glucose [millimoles/L {mmol/L}], Potassium [mmol/L], Sodium [mmol/L], Triglycerides [mmol/L] were reported. Abnormalities that occurred after study treatment start and up to 30 days after study treatment discontinuation, that were not present at baseline, were treatment-emergent. Marked laboratory abnormalities reported for at least 1 participant were reported in this outcome measure. >=:greater than or equal to; >:greater than; <:less than; ULN: upper limit of normal; L:Low, H:High, LLL:lower/worse than LL, HHH:higher/worse than HH.
Change From Baseline in Hemoglobin Over Time
Time frame: Baseline up to Week 130
Change from baseline in hemoglobin over time was reported in this outcome measure.
Change From Baseline in Hematocrit Over Time
Time frame: Baseline up to Week 130
Change from baseline in hematocrit over time was reported in this outcome measure.
Change From Baseline in Leukocytes, Neutrophils, Lymphocytes, and Platelets Over Time
Time frame: Baseline up to Week 130
Change from baseline in leukocytes, neutrophils, lymphocytes, and platelets over time were reported in this outcome measure.
Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP) Over Time
Time frame: Baseline up to Week 130
Change from baseline in systolic and diastolic arterial BP over time was reported in this outcome measure.
Change From Baseline in Pulse Rate Over Time
Time frame: Baseline up to Week 130
Change from baseline in pulse rate over time was reported in this outcome measure.
Change From Baseline in Peripheral Oxygen Saturation (SpO2) Over Time
Time frame: Baseline up to Week 130
Change from baseline in SpO2 over time was reported in this outcome measure.
Change From Baseline in Body Weight Over Time
Time frame: Baseline up to Week 130
Change from baseline in body weight over time was reported in this outcome measure.
Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl Transferase (GGT) Over Time
Time frame: Baseline up to Week 130
Change from baseline in ALT, AST, AP, and GGT over time were reported in this outcome measure.
Change From Baseline in Bilirubin, Direct Bilirubin, and Creatinine Over Time
Time frame: Baseline up to Week 130
Change from baseline in bilirubin, direct bilirubin, and creatinine over time were reported in this outcome measure.
Change From Baseline in Glomerular Filtration Rate (GFR) Over Time
Time frame: Baseline up to Week 130
Change from baseline in GFR over time was reported in this outcome measure.
Change From Baseline in Prothrombin Time Over Time
Time frame: Baseline up to Week 130
Change from baseline in prothrombin time over time was reported in this outcome measure.
Change From Baseline in Prothrombin International Normalized Ratio Over Time
Time frame: Baseline up to Week 130
Change from baseline in prothrombin international normalized ratio over time was reported in this outcome measure.
2 secondary outcomes
Change From Baseline in Peak Oxygen Uptake/Consumption (VO2)
Time frame: Baseline, Week 52, and Week 104
Change From Baseline in Mean Count Per Minute of Daily Physical Activity Measured by Accelerometer (PA-Ac)
Time frame: Baseline, Week 26, Week 52, Week 78, and Week 104
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu
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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.
Thierry Francis Briand, MD study director
Actelion
19 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing macitentan 10 mg in people with Congenital Heart Disease With Fontan Circulation, run by Actelion at 19 sites in 11 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia, Poland, United States, China, France and 6 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 7 Mar 2023). 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 133 weeks). The study lists 17 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 7 Mar 2023.