Cystic FibrosisPhase 1/2NCT02718495
Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis
A Phase 1/2 study testing PTI-428 in people with Cystic Fibrosis, run by Proteostasis Therapeutics, Inc. at 29 sites in 5 countries.
Trial summary
This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- PTI-428
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 29 sitesin 5 countries
- Study dates
- 19 Jul 2016to 28 Nov 2017
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of CF.
- Forced expiratory volume in 1 second (FEV1) 40-90% predicted.
- Non-smoker and non-tobacco user for a minimum of 30 days prior to screening and for the duration of the study.
Who cannot join
- Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1.
- History of cancer within the past five years (excluding cervical CIS with curative therapy for at least one year prior to screening and non-melanoma skin cancer).
- History of organ transplantation.
- Any sinopulmonary infection or CF exacerbation requiring a change or addition of medication (including antibiotics) within 1 month of Study Day 1 or any other clinically significant infection as determined by the investigator within 1 month of Day 1.
- History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
- Male and female of child-bearing potential, unless they are using highly effective methods of contraception during participation in the clinical study and for 4 weeks after termination from study.
- Pregnant or nursing women.
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
United States20 sites
Central Florida Pulmonary Group
Altamonte Springs, Florida, 32803
Universiy of Michigan Health System
Ann Arbor, Michigan, 48109
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, 83712
Massachusetts General Hospital
Boston, Massachusetts, 02114
Childrens Hospital Boston
Boston, Massachusetts, 02115
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University Memorial Hospital
Chicago, Illinois, 60611
Duke University Health System
Durham, North Carolina, 27710
University of Florida College of Medicine
Gainesville, Florida, 32610
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas, 66160
Children's Lung Specialists
Las Vegas, Nevada, 89107
University of Louisville
Louisville, Kentucky, 40202
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Quintiles Overland Park Phase 1 Unit
Overland Park, Kansas, 66211
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
Stanford University Medical Center
Stanford, California, 94305
Canada4 sites
Institut de Recherches Cliniques de Montreal
Montreal, Quebec, H2X 0A9
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Paul's Hospital Pacific Lung Research Center
Vancouver, British Columbia, V6Z 1Y6
France2 sites
Groupe Hospitalier Pellegrin - Hôpital des Enfants
Bordeaux, 33076
Hôpital Cochin
Paris, 75014
Germany2 sites
Charite - Campus Virchow-Klinikum
Berlin, 10117
Universitaetsklinikum Frankfurt-Zentrum der Inneren Medizin
Frankfurt, 60590
About this study
Official title: A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis
This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group. Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will enroll adult subjects with CF, including those on background treatment with KALYDECO® and those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts. Approximately 136 subjects will be enrolled.
Read the detailed description
PART A The SAD treatment group is comprised of 3 cohorts where subjects will be randomized to either PTI-428 or placebo. Following the conclusion of at least 3 SAD treatment groups, a set of adult subjects diagnosed with CF will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 cohorts. MAD Cohort 1 will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months at the time of randomization. MAD Cohorts 2 and 3 will enroll adult subjects with CF who are not currently on any background therapies. Subjects in all MAD cohorts will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 7 Days.
PART B Following the conclusion of MAD Cohort 1, a set of adult subjects diagnosed with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months will participate in Part B. The Part B Phase II treatment group is comprised of 2 cohorts where subjects will be randomized to either PTI-428 or placebo. Each dose will be administered QD for a total of 28 days.
PART C Following the conclusion of Part B Phase II, a set of adult subjects diagnosed with CF will participate in Part C. The Part C Phase II treatment group is comprised of 3 cohorts. Part C Cohort 1 will enroll adult subjects with CF who are eligible to take, but not currently taking, ORKAMBI® in accordance with the approved label. Part C Cohort 2 will enroll adult subjects with CF currently on stable KALYDECO® background therapy for a minimum of 3 months at the time of randomization. Part C Cohort 3 will enroll adult subjects with CF who are not currently on any background therapies and are pancreatic sufficient. Each PTI-428 or placebo dose will be administered QD for a total of 28 days.
- Conditions
- Cystic Fibrosis
- Being tested
- PTI-428, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTI-428Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Part A | Placebo comparator | Part A consists of two treatment groups, SAD and MAD. Both treatment groups will consist of 3 cohorts. In SAD, subjects will receive a single dose of PTI-428 or placebo. In MAD, subjects will receive once daily dosing of PTI-428 or placebo for 7 days. Receives: Drug: PTI-428; Drug: Placebo |
| Part B | Placebo comparator | Part B will consist of 2 cohorts. Subjects will receive once daily dosing of PTI-428 or placebo for 28 days. Receives: Drug: PTI-428; Drug: Placebo |
| Part C | Placebo comparator | Part C will consist of 3 cohorts. Subjects will receive once daily dosing of PTI-428 or placebo for 28 days. Receives: Drug: PTI-428; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAD: safety and tolerability as assessed by adverse events, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Measured: Baseline to Day 7
MAD: safety and tolerability as assessed by adverse events, pulomonary function tests, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Measured: Baseline to Day 14
Part B and Part C Cohorts 2 and 3: safety and tolerability as assessed by adverse events, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Measured: Baseline to Day 35
Part C Cohort 1: safety and tolerability as assessed by adverse events, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Measured: Baseline to Day 49
Secondary outcomes (25)
SAD: apparent terminal half-life (t1/2) of single oral dose
Measured: Baseline through 72 hours post dose
SAD: time to reach maximum plasma concentration (Tmax) of single oral dose
Measured: Baseline through 72 hours post dose
SAD: maximum plasma concentration (Cmax) of single oral dose
Measured: Baseline through 72 hours post dose
SAD: area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of single oral dose
Measured: Baseline through 72 hours post dose
MAD: t1/2 of multiple oral doses
Measured: Baseline through 24 hours post Day 7 dose
MAD: Tmax of multiple oral doses
Measured: Baseline through 24 hours post Day 7 dose
MAD: Cmax of multiple oral doses
Measured: Baseline through 24 hours post Day 7 dose
MAD: AUC0-t of multiple oral doses
Measured: Baseline through 24 hours post Day 7 dose
MAD: area under the concentration-time curve from time 0 to infinity (AUC0-∞) of multiple oral doses
Measured: Baseline through 24 hours post Day 7 dose
Part B and Part C Cohorts 2 and 3: t1/2 of multiple oral doses
Measured: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: Tmax of multiple oral doses
Measured: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: Cmax of multiple oral doses
Measured: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: AUC0-t of multiple oral doses
Measured: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: AUC0-∞ of multiple oral doses
Measured: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: change in forced expiratory volume in one second (FEV1) over time
Measured: Baseline through Day 35
Part B and Part C Cohorts 2 and 3: change in sweat chloride over time
Measured: Baseline through Day 35
Part B and Part C Cohorts 2 and 3: change in weight over time
Measured: Baseline through Day 35
Part C Cohort 1: t1/2 of multiple oral doses
Measured: Baseline through Day 42
Part C Cohort 1: Tmax of multiple oral doses
Measured: Baseline through Day 42
Part C Cohort 1: Cmax of multiple oral doses
Measured: Baseline through Day 42
Part C Cohort 1: AUC0-t of multiple oral doses
Measured: Baseline through Day 42
Part C Cohort 1: AUC0-∞ of multiple oral doses
Measured: Baseline through Day 42
Part C Cohort 1: change in FEV1 over time
Measured: Baseline through Day 49
Part C Cohort 1: change in sweat chloride over time
Measured: Baseline through Day 49
Part C Cohort 1: change in weight over time
Measured: Baseline through Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study start19 Jul 2016
- Primary completion28 Nov 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Proteostasis Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718495
- Sponsor's protocol ID
- PTI-428-01
- Status last verified
- Mar 2019
- First submitted
- 10 Mar 2016
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02718495
- Acronym / sponsor ID
- PTI-428-01
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Proteostasis Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 28 Nov 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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 trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group. Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will enroll adult subjects with CF, including those on background treatment with KALYDECO® and those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts. Approximately 136 subjects will be enrolled.
Detailed description
PART A The SAD treatment group is comprised of 3 cohorts where subjects will be randomized to either PTI-428 or placebo. Following the conclusion of at least 3 SAD treatment groups, a set of adult subjects diagnosed with CF will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 cohorts. MAD Cohort 1 will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months at the time of randomization. MAD Cohorts 2 and 3 will enroll adult subjects with CF who are not currently on any background therapies. Subjects in all MAD cohorts will be randomized to either PTI-428 or placebo. Each dose will be administered once daily (QD) for a total of 7 Days.
PART B Following the conclusion of MAD Cohort 1, a set of adult subjects diagnosed with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months will participate in Part B. The Part B Phase II treatment group is comprised of 2 cohorts where subjects will be randomized to either PTI-428 or placebo. Each dose will be administered QD for a total of 28 days.
PART C Following the conclusion of Part B Phase II, a set of adult subjects diagnosed with CF will participate in Part C. The Part C Phase II treatment group is comprised of 3 cohorts. Part C Cohort 1 will enroll adult subjects with CF who are eligible to take, but not currently taking, ORKAMBI® in accordance with the approved label. Part C Cohort 2 will enroll adult subjects with CF currently on stable KALYDECO® background therapy for a minimum of 3 months at the time of randomization. Part C Cohort 3 will enroll adult subjects with CF who are not currently on any background therapies and are pancreatic sufficient. Each PTI-428 or placebo dose will be administered QD for a total of 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A | Placebo comparator | Drug: PTI-428, Drug: PlaceboPart A consists of two treatment groups, SAD and MAD. Both treatment groups will consist of 3 cohorts. In SAD, subjects will receive a single dose of PTI-428 or placebo. In MAD, subjects will receive once daily dosing of PTI-428 or placebo for 7 days. |
| Part B | Placebo comparator | Drug: PTI-428, Drug: PlaceboPart B will consist of 2 cohorts. Subjects will receive once daily dosing of PTI-428 or placebo for 28 days. |
| Part C | Placebo comparator | Drug: PTI-428, Drug: PlaceboPart C will consist of 3 cohorts. Subjects will receive once daily dosing of PTI-428 or placebo for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of CF.
- Forced expiratory volume in 1 second (FEV1) 40-90% predicted.
- Non-smoker and non-tobacco user for a minimum of 30 days prior to screening and for the duration of the study.
Key exclusion criteria (7 listed)
- Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to Study Day 1.
- History of cancer within the past five years (excluding cervical CIS with curative therapy for at least one year prior to screening and non-melanoma skin cancer).
- History of organ transplantation.
- Any sinopulmonary infection or CF exacerbation requiring a change or addition of medication (including antibiotics) within 1 month of Study Day 1 or any other clinically significant infection as determined by the investigator within 1 month of Day 1.
- History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
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 |
|---|---|---|
| PTI-428 | Drug | Part A, Part B, Part C |
| Placebo | Drug | Part A, Part B, Part C |
Primary outcome
SAD: safety and tolerability as assessed by adverse events, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Time frame: Baseline to Day 7
MAD: safety and tolerability as assessed by adverse events, pulomonary function tests, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Time frame: Baseline to Day 14
Part B and Part C Cohorts 2 and 3: safety and tolerability as assessed by adverse events, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Time frame: Baseline to Day 35
Part C Cohort 1: safety and tolerability as assessed by adverse events, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs
Time frame: Baseline to Day 49
25 secondary outcomes
SAD: apparent terminal half-life (t1/2) of single oral dose
Time frame: Baseline through 72 hours post dose
SAD: time to reach maximum plasma concentration (Tmax) of single oral dose
Time frame: Baseline through 72 hours post dose
SAD: maximum plasma concentration (Cmax) of single oral dose
Time frame: Baseline through 72 hours post dose
SAD: area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) of single oral dose
Time frame: Baseline through 72 hours post dose
MAD: t1/2 of multiple oral doses
Time frame: Baseline through 24 hours post Day 7 dose
MAD: Tmax of multiple oral doses
Time frame: Baseline through 24 hours post Day 7 dose
MAD: Cmax of multiple oral doses
Time frame: Baseline through 24 hours post Day 7 dose
MAD: AUC0-t of multiple oral doses
Time frame: Baseline through 24 hours post Day 7 dose
MAD: area under the concentration-time curve from time 0 to infinity (AUC0-∞) of multiple oral doses
Time frame: Baseline through 24 hours post Day 7 dose
Part B and Part C Cohorts 2 and 3: t1/2 of multiple oral doses
Time frame: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: Tmax of multiple oral doses
Time frame: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: Cmax of multiple oral doses
Time frame: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: AUC0-t of multiple oral doses
Time frame: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: AUC0-∞ of multiple oral doses
Time frame: Baseline through 24 hours post Day 28 dose
Part B and Part C Cohorts 2 and 3: change in forced expiratory volume in one second (FEV1) over time
Time frame: Baseline through Day 35
Part B and Part C Cohorts 2 and 3: change in sweat chloride over time
Time frame: Baseline through Day 35
Part B and Part C Cohorts 2 and 3: change in weight over time
Time frame: Baseline through Day 35
Part C Cohort 1: t1/2 of multiple oral doses
Time frame: Baseline through Day 42
Part C Cohort 1: Tmax of multiple oral doses
Time frame: Baseline through Day 42
Part C Cohort 1: Cmax of multiple oral doses
Time frame: Baseline through Day 42
Part C Cohort 1: AUC0-t of multiple oral doses
Time frame: Baseline through Day 42
Part C Cohort 1: AUC0-∞ of multiple oral doses
Time frame: Baseline through Day 42
Part C Cohort 1: change in FEV1 over time
Time frame: Baseline through Day 49
Part C Cohort 1: change in sweat chloride over time
Time frame: Baseline through Day 49
Part C Cohort 1: change in weight over time
Time frame: Baseline through Day 49
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 21 Mar 2019.
- Individual participant dataSharing planned: Yes
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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.
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PTI-428 in people with Cystic Fibrosis, run by Proteostasis Therapeutics, Inc. at 29 sites in 5 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 3 inclusion and 7 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 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada, France, Germany, Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
SAD: safety and tolerability as assessed by adverse events, safety labs: hematology, chemistry, and urinalysis, electrocardiograms (ECGs), physical examinations, and vital signs (time frame: Baseline to Day 7). 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 21 Mar 2019.