Aplastic Anemia (AA)NCT06669221
Effectiveness of Early Intervention in Transfusion Independent Aplastic Anemia: a Retrospective Medical Claims Database Study
An observational study of Aplastic Anemia (AA), run by Novartis Pharmaceuticals at 1 site in Japan.
Trial summary
This was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database to evaluate the effectiveness of early drug intervention in preventing transfusion compared to watchful observation among adult transfusion-independent aplastic anemia (AA)… Read more about this study
- Who is it for?
- Ages 15 to 90 years
- Conditions the study is for
- Aplastic Anemia (AA)
- How many people
- 1,603 participants
- Where
- 1 siteJapan
- Study dates
- 5 May 2022to 3 Nov 2023
- 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 15 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Having at least one confirmed diagnosis of AA within the selection period (1 inpatient or 2 outpatient claims per the International Statistical Classification of Diseases, 10th Revision [ICD-10] code, without any suspicion flag).
- Being aged 15 to 90 years at the index date.
- Having at least 3 months of continuous enrolment prior to the index date.
Who cannot join
- Having a blood transfusion recorded any time before the index date.
- Having anti-thymocyte globulin (ATG) treatment recorded within 3 months after the index date.
- Having at least one prescription record for any of the drug treatments of interest any time before the index date.
- Having a diagnosis of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML) or other leukemia any time before the index date.
- Having an AA diagnosis (without suspicious flag) date earlier than the start of patient's observation in the database.
- Having less than 6 months of continuous follow-up.
- Safety Population - Additional Exclusion Criterion:
- Having a diagnosis of hepatotoxicity, kidney dysfunction, hypertension, or diabetes mellitus any time before the index date.
Trial locations and contacts
1 site in 1 country.
About this study
This was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database to evaluate the effectiveness of early drug intervention in preventing transfusion compared to watchful observation among adult transfusion-independent aplastic anemia (AA) patients in Japan.
- Conditions
- Aplastic Anemia (AA)
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Early drug intervention group | Patients who had at least one prescription record associated with any of the drug treatments of interest (cyclosporine A, eltrombopag, romiplostin, danazol, or methenolone) during each period of interest before the first transfusion record during the follow-up period. | |
| Watchful observation group | Patients with no prescription record associated with any of the drug treatments of interest (cyclosporine A, eltrombopag, romiplostin, danazol, or methenolone) during the follow-up period and before the first transfusion record, if any. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability of Having Blood Transfusion in the Matched Effectiveness Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Crude Hazard Ratios of Having Blood Transfusion After 6 Months of Follow-up in the Matched Effectiveness Population
Measured: Baseline, 6 months
Adjusted Hazard Ratios of Having Blood Transfusion After 6 Months of Follow-up in the Matched Effectiveness Population
Measured: 6 months
Secondary outcomes (44)
Sex
Measured: Baseline
Age
Measured: Baseline
Weight
Measured: Baseline
Body Mass Index (BMI)
Measured: Baseline
Number of Patients With Aplastic Anemia, per Severity Level
Measured: Baseline
Number of Patients With Immune Thrombocytopenia (ITP) Diagnosis Before Index Date
Measured: Baseline
Number of Patients With Myelodysplastic Syndrome (MDS) Diagnosis Before Index Date
Measured: Baseline
Number of Patients With Pre-index Comorbidities
Measured: Baseline
Number of Patients With Pre-index Use of Chloramphenicol
Measured: Baseline
Platelet Count
Measured: Baseline
Neutrophil Count
Measured: Baseline
Hemoglobin Level
Measured: Baseline
Number of Patients Per Treatment Therapy in the Matched Effectiveness Population
Measured: Baseline
Number of Patients With Aplastic Anemia in the Matched Effectiveness Population, per Severity Level
Measured: Baseline
Number of Patients in the Matched Effectiveness Population Who Discontinued
Measured: Baseline, at 6 and 9 months, and at 1 and 2 years
Probability of Having Blood Transfusion in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Stem-Cell Transplantation (SCT) in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Anti-Thymocyte Globulin (ATG) in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Blood Transfusion at Different Timepoints by Drug Categories in the Matched Effectiveness Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having SCT at Different Timepoints by Drug Categories in the Matched Effectiveness Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having ATG at Different Timepoints by Drug Categories in the Matched Effectiveness Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having a Bleeding Event in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Cataract in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Diabetes in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Hepatotoxicity in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Hypertension in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having an Infection in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Kidney Dysfunction in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML) or Another Leukemia in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having MDS in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Paroxysmal Nocturnal Hemoglobinuria (PNH) in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having a Thromboembolic Event in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Myelofibrosis in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having a Bleeding Event by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Cataract by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Diabetes by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Hepatotoxicity by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having an Infection by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Kidney Dysfunction by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having AML, CMML or Another Leukemia by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having MDS by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having PNH by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having a Thromboembolic Event by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Myelofibrosis by Drug Categories in the Matched Safety Population
The Kaplan-Meier survival analysis technique was used to estimate probability.
Measured: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start5 May 2022
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aplastic Anemia (AA)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669221
- Sponsor's protocol ID
- CETB115EJP05
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Early Intervention in Transfusion Independent Aplastic Anemia: a Retrospective Medical Claims Database Study
- ClinicalTrials.gov ID
- NCT06669221
- Acronym / sponsor ID
- CETB115EJP05
- Conditions
- Aplastic Anemia (AA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,603 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 1 Nov 2024 (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.
This was a retrospective non-interventional cohort study with secondary use of data from the Medical Data Vision (MDV) hospital-based database to evaluate the effectiveness of early drug intervention in preventing transfusion compared to watchful observation among adult transfusion-independent aplastic anemia (AA) patients in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early drug intervention group | – | –Patients who had at least one prescription record associated with any of the drug treatments of interest (cyclosporine A, eltrombopag, romiplostin, danazol, or methenolone) during each period of interest before the first transfusion record during the follow-up period. |
| Watchful observation group | – | –Patients with no prescription record associated with any of the drug treatments of interest (cyclosporine A, eltrombopag, romiplostin, danazol, or methenolone) during the follow-up period and before the first transfusion record, if any. |
Who may qualify
- Ages
- 15 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (3 listed)
- Having at least one confirmed diagnosis of AA within the selection period (1 inpatient or 2 outpatient claims per the International Statistical Classification of Diseases, 10th Revision [ICD-10] code, without any suspicion flag).
- Being aged 15 to 90 years at the index date.
- Having at least 3 months of continuous enrolment prior to the index date.
Key exclusion criteria (8 listed)
- Having a blood transfusion recorded any time before the index date.
- Having anti-thymocyte globulin (ATG) treatment recorded within 3 months after the index date.
- Having at least one prescription record for any of the drug treatments of interest any time before the index date.
- Having a diagnosis of acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML) or other leukemia any time before the index date.
- Having an AA diagnosis (without suspicious flag) date earlier than the start of patient's observation in the database.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Probability of Having Blood Transfusion in the Matched Effectiveness Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
The Kaplan-Meier survival analysis technique was used to estimate probability.
Crude Hazard Ratios of Having Blood Transfusion After 6 Months of Follow-up in the Matched Effectiveness Population
Time frame: Baseline, 6 months
Adjusted Hazard Ratios of Having Blood Transfusion After 6 Months of Follow-up in the Matched Effectiveness Population
Time frame: 6 months
44 secondary outcomes
Sex
Time frame: Baseline
Age
Time frame: Baseline
Weight
Time frame: Baseline
Body Mass Index (BMI)
Time frame: Baseline
Number of Patients With Aplastic Anemia, per Severity Level
Time frame: Baseline
Number of Patients With Immune Thrombocytopenia (ITP) Diagnosis Before Index Date
Time frame: Baseline
Number of Patients With Myelodysplastic Syndrome (MDS) Diagnosis Before Index Date
Time frame: Baseline
Number of Patients With Pre-index Comorbidities
Time frame: Baseline
Number of Patients With Pre-index Use of Chloramphenicol
Time frame: Baseline
Platelet Count
Time frame: Baseline
Neutrophil Count
Time frame: Baseline
Hemoglobin Level
Time frame: Baseline
Number of Patients Per Treatment Therapy in the Matched Effectiveness Population
Time frame: Baseline
Number of Patients With Aplastic Anemia in the Matched Effectiveness Population, per Severity Level
Time frame: Baseline
Number of Patients in the Matched Effectiveness Population Who Discontinued
Time frame: Baseline, at 6 and 9 months, and at 1 and 2 years
Probability of Having Blood Transfusion in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Stem-Cell Transplantation (SCT) in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Anti-Thymocyte Globulin (ATG) in Early Drug Intervention and Watchful Observation Matched Patients From the Effectiveness Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Blood Transfusion at Different Timepoints by Drug Categories in the Matched Effectiveness Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having SCT at Different Timepoints by Drug Categories in the Matched Effectiveness Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having ATG at Different Timepoints by Drug Categories in the Matched Effectiveness Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having a Bleeding Event in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Cataract in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Diabetes in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Hepatotoxicity in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Hypertension in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having an Infection in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Kidney Dysfunction in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML) or Another Leukemia in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having MDS in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Paroxysmal Nocturnal Hemoglobinuria (PNH) in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having a Thromboembolic Event in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Myelofibrosis in Early Drug Intervention and Watchful Observation Matched Patients From the Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having a Bleeding Event by Drug Categories in the Matched Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Cataract by Drug Categories in the Matched Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Diabetes by Drug Categories in the Matched Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Hepatotoxicity by Drug Categories in the Matched Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having an Infection by Drug Categories in the Matched Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having Kidney Dysfunction by Drug Categories in the Matched Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
Probability of Having AML, CMML or Another Leukemia by Drug Categories in the Matched Safety Population
Time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years
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 1 Nov 2024.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 Aplastic Anemia (AA), run by Novartis Pharmaceuticals at 1 site in Japan.
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 1 Nov 2024. 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 Japan. 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?
Probability of Having Blood Transfusion in the Matched Effectiveness Population (time frame: Baseline, at 6 and 9 months, and at 1, 2, 5, and 10 years). The study lists 3 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 1 Nov 2024.