Cystic FibrosisPhase 2NCT02951195

A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

A Phase 2 study testing VX-152, TEZ/IVA and IVA in people with Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cystic Fibrosis
What is being tested?: VX-152, TEZ/IVA and IVA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 16 sitesUnited States
Study dates: Nov 2016to Jan 2018
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
Body weight ≥35 kg.
Sweat chloride value ≥ 60 mmol/L from test results obtained during screening.
Subjects must have an eligible CFTR genotype:
Cohorts 1A, 1B, 1C: Heterozygous for F508del and a minimal function mutation known or predicted not to respond to TEZ and/or IVA.
Cohorts 2A, 2B: Homozygous for F508del.

Show all 9Show fewer

Subjects must have an FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height at the Screening Visit.
Stable CF disease as judged by the investigator.
Willing to remain on a stable CF medication regimen through the planned end of treatment or if applicable the Safety Follow-up Visit.

Who cannot join

History of any comorbidity that in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
History of cirrhosis with portal hypertension.
Risk factors for Torsade de Pointes.
History of hemolysis.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.
Clinically significant abnormal laboratory values at screening.

Show all 16Show fewer

An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 28 days before the first dose of study drug.
Lung infection with organisms associated with a more rapid decline in pulmonary status.
An acute illness not related to CF within 14 days before the first dose of study drug.
A standard digital ECG demonstrating QTc >450 msec at screening.
History of solid organ or hematological transplantation.
History or evidence of cataract or lens opacity determined to be clinically significant by the ophthalmologist or optometrist, based on the ophthalmologic examination during the Screening Period.
History of alcohol or drug abuse in the past year, including but not limited to, cannabis, cocaine, and opiates, as deemed by the investigator.
Ongoing or prior participation in an investigational drug study with certain exceptions.
Use of commercially available CFTR modulator within 14 days before screening (applies only to Cohorts 1A, 1B, and 1C).
Pregnant or nursing females: Females of childbearing potential must have a negative pregnancy test at screening and Day 1.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Study site
Akron, Ohio
Study site
Birmingham, Alabama
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Cleveland, Ohio
Study site
Fort Worth, Texas
Study site
Houston, Texas
Study site
La Jolla, California
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Orlando, Florida
Study site
Peoria, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
St Louis, Missouri

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis

This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and ivacaftor (IVA; VX-770) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ and/or IVA therapy (F508del/MF), or who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F508del/F508del).

Conditions: Cystic Fibrosis
Being tested: VX-152, TEZ/IVA, IVA, 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.

VX-152Drug
Tablet for oral administration.
TEZ/IVADrug
Also called VX-661/VX-770, Tezacaftor/Ivacaftor
Fixed-dose combination tablet for oral administration.
IVADrug
Also called VX-770, Ivacaftor
Tablet for oral administration.
PlaceboDrug
Placebo matched to VX-152.
PlaceboDrug
Placebo matched to VX-152/TEZ/IVA triple combination (TC).

Study groups in NCT02951195
Study group	Role	What they receive
Part 1: Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Part 1 Cohort 1A: TC	Experimental	Not described Receives: Drug: VX-152; Drug: TEZ/IVA; Drug: IVA
Part 1 Cohort 1B: TC	Experimental	Not described Receives: Drug: VX-152; Drug: TEZ/IVA; Drug: IVA
Part 1 Cohort 1C: TC	Experimental	Not described Receives: Drug: VX-152; Drug: TEZ/IVA; Drug: IVA
Part 2 Cohort 2A: TEZ/IVA	Active comparator	Not described Receives: Drug: TEZ/IVA; Drug: IVA; Drug: Placebo
Part 2 Cohort 2A: TC	Experimental	Not described Receives: Drug: VX-152; Drug: TEZ/IVA; Drug: IVA
Part 2 Cohort 2B: TEZ/IVA	Active comparator	Not described Receives: Drug: TEZ/IVA; Drug: IVA; Drug: Placebo
Part 2 Cohort 2B: TC	Experimental	Not described Receives: Drug: VX-152; Drug: TEZ/IVA; Drug: IVA

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Measured: From Baseline at Day 15
Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Measured: From Baseline Through Day 29

Secondary outcomes (7)

Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A
Sweat samples were collected using an approved collection device.
Measured: From Baseline at Day 15
Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B
Sweat samples were collected using an approved collection device.
Measured: From Baseline Through Day 29
Relative Change in ppFEV1 at Day 15 for Part 1 and Part 2 Cohort 2A
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Measured: From Baseline at Day 15
Relative Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Measured: From Baseline Through Day 29
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 15 for Part 1 and Part 2 Cohort 2A
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Measured: From Baseline at Day 15
Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 29 for Part 2 Cohort 2B
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms, score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life.
Measured: From Baseline at Day 29
Pre-dose Plasma Concentration (Ctrough) of VX-152, TEZ, M1-TEZ, IVA, and M1-IVA
Measured: Pre-dose at Day 8, Day 15 and Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2016Jan 2018

First posted1 Nov 2016 (estimated)
Study startNov 2016
Primary completionJan 2018
Study completionJan 2018

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 Cystic FibrosisStudies of the same condition, open and under way.
More trials run by Vertex Pharmaceuticals IncorporatedThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02951195
Sponsor's protocol ID: VX16-152-102
Status last verified: Jan 2021
First submitted: 26 Oct 2016
Last updated: 28 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
ClinicalTrials.gov ID: NCT02951195
Acronym / sponsor ID: VX16-152-102
Conditions: Cystic Fibrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
Study start: Nov 2016 (actual)
Primary completion: Jan 2018 (actual)
Study completion: Jan 2018 (actual)
First posted: 1 Nov 2016 (estimated)
Results: Posted 28 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 8

Arm	Type	Receives
Part 1: Placebo	Placebo comparator	Drug: Placebo
Part 1 Cohort 1A: TC	Experimental	Drug: VX-152, Drug: TEZ/IVA, Drug: IVA
Part 1 Cohort 1B: TC	Experimental	Drug: VX-152, Drug: TEZ/IVA, Drug: IVA
Part 1 Cohort 1C: TC	Experimental	Drug: VX-152, Drug: TEZ/IVA, Drug: IVA
Part 2 Cohort 2A: TEZ/IVA	Active comparator	Drug: TEZ/IVA, Drug: IVA, Drug: Placebo
Part 2 Cohort 2A: TC	Experimental	Drug: VX-152, Drug: TEZ/IVA, Drug: IVA
Part 2 Cohort 2B: TEZ/IVA	Active comparator	Drug: TEZ/IVA, Drug: IVA, Drug: Placebo
Part 2 Cohort 2B: TC	Experimental	Drug: VX-152, Drug: TEZ/IVA, Drug: IVA

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Willing and able to comply with scheduled visits, treatment pan, study restrictions, laboratory tests, contraceptive guidelines, and other study procedures.
Body weight ≥35 kg.
Sweat chloride value ≥ 60 mmol/L from test results obtained during screening.
Subjects must have an eligible CFTR genotype:
Subjects must have an FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height at the Screening Visit.

Key exclusion criteria (16 listed)

History of any comorbidity that in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject.
History of cirrhosis with portal hypertension.
Risk factors for Torsade de Pointes.
History of hemolysis.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency assessed at Screening.

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
VX-152Tablet for oral administration.	Drug	Part 1 Cohort 1A: TC, Part 1 Cohort 1B: TC, Part 1 Cohort 1C: TC, Part 2 Cohort 2A: TC, Part 2 Cohort 2B: TC
TEZ/IVAAlso: VX-661/VX-770, Tezacaftor/IvacaftorFixed-dose combination tablet for oral administration.	Drug	Part 1 Cohort 1A: TC, Part 1 Cohort 1B: TC, Part 1 Cohort 1C: TC, Part 2 Cohort 2A: TC, Part 2 Cohort 2A: TEZ/IVA, Part 2 Cohort 2B: TC, Part 2 Cohort 2B: TEZ/IVA
IVAAlso: VX-770, IvacaftorTablet for oral administration.	Drug	Part 1 Cohort 1A: TC, Part 1 Cohort 1B: TC, Part 1 Cohort 1C: TC, Part 2 Cohort 2A: TC, Part 2 Cohort 2A: TEZ/IVA, Part 2 Cohort 2B: TC, Part 2 Cohort 2B: TEZ/IVA
PlaceboPlacebo matched to VX-152.	Drug	Part 2 Cohort 2A: TEZ/IVA, Part 2 Cohort 2B: TEZ/IVA
PlaceboPlacebo matched to VX-152/TEZ/IVA triple combination (TC).	Drug	Part 1: Placebo

Primary outcome

Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)
Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A
Time frame: From Baseline at Day 15
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B
Time frame: From Baseline Through Day 29
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.

7 secondary outcomes

Absolute Change in Sweat Chloride Concentrations at Day 15 for Part 1 and Part 2 Cohort 2A
Time frame: From Baseline at Day 15
Absolute Change in Sweat Chloride Concentrations Through Day 29 for Part 2 Cohort 2B
Time frame: From Baseline Through Day 29
Relative Change in ppFEV1 at Day 15 for Part 1 and Part 2 Cohort 2A
Time frame: From Baseline at Day 15
Relative Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B
Time frame: From Baseline Through Day 29
Absolute Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 15 for Part 1 and Part 2 Cohort 2A
Time frame: From Baseline at Day 15
Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 29 for Part 2 Cohort 2B
Time frame: From Baseline at Day 29
Pre-dose Plasma Concentration (Ctrough) of VX-152, TEZ, M1-TEZ, IVA, and M1-IVA
Time frame: Pre-dose at Day 8, Day 15 and Day 29

Results and safety

Results posted to the registry on 28 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: Placebo	8	8
Part 1 Cohort 1A: TC	6	6
Part 1 Cohort 1B: TC	10	10
Part 1 Cohort 1C: TC	10	10
Part 2 Cohort 2A: TEZ/IVA	4	4
Part 2 Cohort 2A: TC	10	10
Part 2 Cohort 2B: TEZ/IVA	7	7
Part 2 Cohort 2B: TC	21	21

Primary outcome: Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2). Number. Unit: participants

Measure	Part 1: Placebo n = 8	Part 1 Cohort 1A: TC n = 6	Part 1 Cohort 1B: TC n = 10	Part 1 Cohort 1C: TC n = 10	Part 2 Cohort 2A: TEZ/IVA n = 4	Part 2 Cohort 2A: TC n = 10	Part 2 Cohort 2B: TEZ/IVA n = 7	Part 2 Cohort 2B: TC n = 21
Participants with TEAEs	8	3	7	10	3	6	5	19
Participants with SAEs	2	0	0	1	0	0	0	0

Population analysed: Safety Set included all participants who received at least 1 dose of study drug in the treatment period.

Primary outcome: Absolute Change in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 15 for Part 1 and Part 2 Cohort 2A

Time frame: From Baseline at Day 15. Least squares mean (95% Confidence Interval). Unit: percentage points

Measure	Part 1: Placebo n = 8	Part 1 Cohort 1A: TC n = 6	Part 1 Cohort 1B: TC n = 10	Part 1 Cohort 1C: TC n = 10	Part 2 Cohort 2A: TEZ/IVA n = 4	Part 2 Cohort 2A: TC n = 10
Value	-0.8 (-4.8 to 3.3)	5.7 (1.0 to 10.3)	9.7 (6.1 to 13.3)	8.0 (4.0 to 12.0)	-1.0 (-9.9 to 7.8)	7.3 (1.9 to 12.6)

Part 1: Placebo vs Part 1 Cohort 1A: TC: LS Mean Difference: 6.4 (95% CI 0.3 to 12.6), p = 0.0207, Mixed-effects Model for Repeated Measure
Part 1: Placebo vs Part 1 Cohort 1B: TC: LS Mean Difference: 10.5 (95% CI 5.0 to 15.9), p = 0.0002, Mixed-effects Model for Repeated Measure
Part 1: Placebo vs Part 1 Cohort 1C: TC: LS Mean Difference: 8.8 (95% CI 3.0 to 14.5), p = 0.0019, Mixed-effects Model for Repeated Measure

Population analysed: Full Analysis Set (FAS) included all randomized participants with the intended cystic fibrosis transmembrane conductance regulator protein (CFTR) allele mutation who received at least 1 dose of study drug in the treatment period. As pre-specified in analysis plan, only Part 1 and Part 2 Cohort 2A arms were assessed for this outcome measure.

Primary outcome: Absolute Change in ppFEV1 Through Day 29 for Part 2 Cohort 2B

Time frame: From Baseline Through Day 29. Least squares mean (95% Confidence Interval). Unit: percentage points

Measure	Part 2 Cohort 2B: TEZ/IVA n = 7	Part 2 Cohort 2B: TC n = 21
Value	-2.2 (-6.6 to 2.1)	6.5 (4.0 to 9.0)

Part 2 Cohort 2B: TEZ/IVA vs Part 2 Cohort 2B: TC: LS Mean Difference: 8.7 (95% CI 3.7 to 13.8), p = 0.0007, Mixed-effects Model for Repeated Measure

Population analysed: FAS. As pre-specified in analysis plan, only Part 2 Cohort 2B arms were assessed for this outcome measure.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Placebo	2 of 8 (25%)	8 of 8 (100%)	0 of 8
Part 1 Cohort 1A: TC	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 1 Cohort 1B: TC	0 of 10 (0%)	7 of 10 (70%)	0 of 10
Part 1 Cohort 1C: TC	1 of 10 (10%)	9 of 10 (90%)	0 of 10
Part 2 Cohort 2A: TEZ/IVA	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Part 2 Cohort 2A: TC	0 of 10 (0%)	6 of 10 (60%)	0 of 10
Part 2 Cohort 2B: TEZ/IVA	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
Part 2 Cohort 2B: TC	0 of 21 (0%)	18 of 21 (85.7%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VX-152, TEZ/IVA and IVA in people with Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 16 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 16 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 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability as Assessed by Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Day 1 Through Safety Follow-up Visit (Up to Day 43 for Part 1 and Day 71 for Part 2)). 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?

On the ClinicalTrials.gov record for NCT02951195.

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 28 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.