Hepatic FailurePhase 1NCT04587622
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
A Phase 1 study testing Icenticaftor in people with Hepatic Failure, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Failure
- What is being tested?
- Icenticaftor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2020to 15 Sep 2022
- Phase
- Phase 1
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and non-child bearing potential female participants, 18 to 75 years of age (inclusive) at Screening.
- Participants must weigh at least 50.0 kg and must have a body mass index (BMI) within the range of 18.0 to 38.0 kg/m2, inclusive, at Screening.
- Must be a non-smoker or agree to smoke no more than 5 cigarettes (or equivalent) per day from Screening until the End of Study. Participants must maintain the same smoking status throughout the study (i.e. smoker or non smoker).
- Seated vital signs must be within the following ranges at Screening and Baseline:
- Body temperature, 35.0 to 37.5°C, inclusive.
- Systolic blood pressure, 89 to 159 mmHg, inclusive.
Show all 9Show fewer
- Diastolic blood pressure, 50 to 99 mmHg, inclusive.
- Pulse rate, 50 to 99 bpm, inclusive.
- Hepatic impairment as defined by the Child-Pugh classification for severity of liver disease
Who cannot join
- Use of other investigational drugs within 5 half-lives prior to dosing of study treatment, or within 30 days, whichever is longer; or longer if required by local regulations.
- Are taking medications prohibited to be taken with the study treatment
- Known history of, or current clinically significant arrhythmias. Have clinically significant ECG abnormality or history of long-QT syndrome or whose QT interval corrected by Fridericia's formula (QTcF) is prolonged (> 480 msec) at Screening. Participants having myocardial infarction ≥ 5 years ago are eligible to participate.
- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
- Healthy Participants:
- Each participant must match in age (± 10 years), gender, weight (± 15%), and smoking status to participants in Group 2, 3, or 4.
Show all 23Show fewer
- Seated vital signs must be within the following ranges at Screening and Baseline:
- Body temperature, 35.0 to 37.5°C, inclusive.
- Systolic blood pressure, 89 to 149 mmHg, inclusive.
- Diastolic blood pressure, 50 to 89 mmHg, inclusive.
- Pulse rate, 40 to 90 bpm, inclusive.
- Participants must be in good health as determined by medical history, physical examination, ECG, and clinical laboratory tests at Screening.
- Liver disease or liver injury as indicated by abnormal liver function tests.
- Chronic infection with HBV or HCV.
- History or presence of impaired renal function.
- Hepatic Impairment Participants:
- Have severe complications of liver disease within the preceding 3 months of Screening.
- Emergency room visit or hospitalization due to liver disease within the preceding 3 months of Screening.
- Have received liver transplant at any time in the past.
- Have encephalopathy Grade 3 or worse within 28 days prior to dosing of study treatment.
- Have acute hepatitis B (HBV) or hepatitis C (HCV) infection.
- Clinically significant abnormal findings in physical examination or clinical laboratory evaluations not consistent with known liver disease.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novartis Investigative Site
Miami, Florida, 33014-3616
Novartis Investigative Site
Orlando, Florida, 32809
About this study
Official title: A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Systemic Pharmacokinetics of Icenticaftor in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Control Participants
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
Read the detailed description
This is a Phase 1, multi-center study with parallel groups. The study employs a single-dose, open-label design in subjects with mild, moderate, or severe hepatic impairment along with matched healthy control subjects with normal hepatic function. Subjects with normal hepatic function will be matched with subjects with hepatic impairment for gender, age (± 10 years), body weight (± 15%), and smoking status (smoker or non-smoker).
Up to a total of 48 participants will be enrolled in this study (approximately 8 in each mild [Child-Pugh A], moderate [Child-Pugh B], severe hepatic impairment [Child-Pugh C] groups), and up to 24 healthy control subjects). Each participant will receive a single oral dose of 300 mg of icenticaftor (QBW251) on Day 1 under fasting conditions.
The study is comprised of an up to 28-day screening period (Days -28 to -1), a baseline evaluation (Day -1) prior to treatment on Day 1, and a follow-up period of 7 days for pharmacokinetics (PK) sample collection (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose). A safety follow-up contact will be done 30 days after administration of the study drug.
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic PK, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
- Conditions
- Hepatic Failure
- Being tested
- Icenticaftor
- Keywords
- Hepatic impairment, Child-Pugh classification, Icenticaftor, QBW251
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IcenticaftorDrug
Also called QBW251
Single oral dose of 300 mg of icenticaftor (QBW251)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Healthy subjects with normal hepatic function | Experimental | Healthy subjects with normal hepatic function - Control Receives: Drug: Icenticaftor |
| Group 2 - Mild Hepatic Impairment | Experimental | Mild hepatic impairment: Child-Pugh A (Score 5-6) Receives: Drug: Icenticaftor |
| Group 3 - Moderate Hepatic Impairment | Experimental | Moderate hepatic impairment: Child-Pugh B (Score 7-9) Receives: Drug: Icenticaftor |
| Group 4 - Severe Hepatic Impairment | Experimental | Severe hepatic impairment: Child-Pugh C (Score 10-15) Receives: Drug: Icenticaftor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed icenticaftor plasma concentration (Cmax) after single oral dose
Icenticaftor plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of icenticaftor will be determined with Phoenix WinNonlin (Version 6.4 or higher).
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of icenticaftor after single oral dose
AUClast of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUClast calculation.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of icenticaftor after single oral dose
AUCinf of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUCinf calculation.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Time to reach maximum icenticaftor plasma concentration (Tmax) after single oral dose
Icenticaftor plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Tmax of icenticaftor will be determined with Phoenix WinNonlin (Version 6.4 or higher).
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Apparent plasma clearance (CL/F) of icenticaftor after single oral dose
CL/F of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher).
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Apparent volume of distribution during terminal phase (Vz/F) of icenticaftor after single oral dose
Vz/F of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher).
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Elimination half-life (T1/2) of icenticaftor after single oral dose
T1/2 of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). Regression analysis of the terminal plasma elimination phase will be used for T1/2 calculation.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Secondary outcomes (5)
Plasma protein binding free fraction (unbound fraction [fu]) of icenticaftor
The free fraction in plasma fu of icenticaftor will be evaluated at 3 hours post-dose using equilibrium dialysis method.
Measured: 3 hours post-dose
Cmax of unbound icenticaftor (Cmax,u)
Icenticaftor Cmax,u will be calculated as Cmax*fu.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
AUClast of unbound icenticaftor (AUClast,u)
Icenticaftor AUClast,u will be calculated as AUClast*fu.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
AUCinf of unbound icenticaftor (AUCinf,u)
Icenticaftor AUCinf,u will be calculated as AUCinf*fu.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
CL/F of unbound icenticaftor (CL/F,u)
Icenticaftor CL/F,u will be calculated as CL/F/fu.
Measured: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start30 Oct 2020
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic FailureStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587622
- Sponsor's protocol ID
- CQBW251A2104
- Status last verified
- Jun 2024
- First submitted
- 29 Sep 2020
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Systemic Pharmacokinetics of Icenticaftor in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Control Participants
- ClinicalTrials.gov ID
- NCT04587622
- Acronym / sponsor ID
- CQBW251A2104
- Conditions
- Hepatic Failure
- Keywords
- Hepatic impairment, Child-Pugh classification, Icenticaftor, QBW251
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 14 Oct 2020 (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.
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
Detailed description
This is a Phase 1, multi-center study with parallel groups. The study employs a single-dose, open-label design in subjects with mild, moderate, or severe hepatic impairment along with matched healthy control subjects with normal hepatic function. Subjects with normal hepatic function will be matched with subjects with hepatic impairment for gender, age (± 10 years), body weight (± 15%), and smoking status (smoker or non-smoker).
Up to a total of 48 participants will be enrolled in this study (approximately 8 in each mild [Child-Pugh A], moderate [Child-Pugh B], severe hepatic impairment [Child-Pugh C] groups), and up to 24 healthy control subjects). Each participant will receive a single oral dose of 300 mg of icenticaftor (QBW251) on Day 1 under fasting conditions.
The study is comprised of an up to 28-day screening period (Days -28 to -1), a baseline evaluation (Day -1) prior to treatment on Day 1, and a follow-up period of 7 days for pharmacokinetics (PK) sample collection (pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose). A safety follow-up contact will be done 30 days after administration of the study drug.
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic PK, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Healthy subjects with normal hepatic function | Experimental | Drug: IcenticaftorHealthy subjects with normal hepatic function - Control |
| Group 2 - Mild Hepatic Impairment | Experimental | Drug: IcenticaftorMild hepatic impairment: Child-Pugh A (Score 5-6) |
| Group 3 - Moderate Hepatic Impairment | Experimental | Drug: IcenticaftorModerate hepatic impairment: Child-Pugh B (Score 7-9) |
| Group 4 - Severe Hepatic Impairment | Experimental | Drug: IcenticaftorSevere hepatic impairment: Child-Pugh C (Score 10-15) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and non-child bearing potential female participants, 18 to 75 years of age (inclusive) at Screening.
- Participants must weigh at least 50.0 kg and must have a body mass index (BMI) within the range of 18.0 to 38.0 kg/m2, inclusive, at Screening.
- Must be a non-smoker or agree to smoke no more than 5 cigarettes (or equivalent) per day from Screening until the End of Study. Participants must maintain the same smoking status throughout the study (i.e. smoker or non smoker).
- Seated vital signs must be within the following ranges at Screening and Baseline:
- Body temperature, 35.0 to 37.5°C, inclusive.
Key exclusion criteria (23 listed)
- Use of other investigational drugs within 5 half-lives prior to dosing of study treatment, or within 30 days, whichever is longer; or longer if required by local regulations.
- Are taking medications prohibited to be taken with the study treatment
- Known history of, or current clinically significant arrhythmias. Have clinically significant ECG abnormality or history of long-QT syndrome or whose QT interval corrected by Fridericia's formula (QTcF) is prolonged (> 480 msec) at Screening. Participants having myocardial infarction ≥ 5 years ago are eligible to participate.
- Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection.
- Each participant must match in age (± 10 years), gender, weight (± 15%), and smoking status to participants in Group 2, 3, or 4.
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 |
|---|---|---|
| IcenticaftorAlso: QBW251Single oral dose of 300 mg of icenticaftor (QBW251) | Drug | Group 1 - Healthy subjects with normal hepatic function, Group 2 - Mild Hepatic Impairment, Group 3 - Moderate Hepatic Impairment, Group 4 - Severe Hepatic Impairment |
Primary outcome
Maximum observed icenticaftor plasma concentration (Cmax) after single oral dose
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Icenticaftor plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of icenticaftor will be determined with Phoenix WinNonlin (Version 6.4 or higher).
Area under the plasma concentration-time curve from time zero to the last measurable concentration sampling time (AUClast) of icenticaftor after single oral dose
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
AUClast of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUClast calculation.
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of icenticaftor after single oral dose
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
AUCinf of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). The linear trapezoidal rule will be used for AUCinf calculation.
Time to reach maximum icenticaftor plasma concentration (Tmax) after single oral dose
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Icenticaftor plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Tmax of icenticaftor will be determined with Phoenix WinNonlin (Version 6.4 or higher).
Apparent plasma clearance (CL/F) of icenticaftor after single oral dose
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
CL/F of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher).
Apparent volume of distribution during terminal phase (Vz/F) of icenticaftor after single oral dose
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
Vz/F of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher).
Elimination half-life (T1/2) of icenticaftor after single oral dose
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
T1/2 of icenticaftor will be determined using non-compartment methods with Phoenix WinNonlin (Version 6.4 or higher). Regression analysis of the terminal plasma elimination phase will be used for T1/2 calculation.
5 secondary outcomes
Plasma protein binding free fraction (unbound fraction [fu]) of icenticaftor
Time frame: 3 hours post-dose
Cmax of unbound icenticaftor (Cmax,u)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
AUClast of unbound icenticaftor (AUClast,u)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
AUCinf of unbound icenticaftor (AUCinf,u)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
CL/F of unbound icenticaftor (CL/F,u)
Time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose
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 20 Jun 2024.
- Results for CQBW251A2104 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Patient Lay Trial SummaryLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Icenticaftor in people with Hepatic Failure, run by Novartis Pharmaceuticals at 2 sites in United States.
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 9 inclusion and 23 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 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maximum observed icenticaftor plasma concentration (Cmax) after single oral dose (time frame: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144 and 168 hours post-dose). The study lists 7 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 20 Jun 2024.