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Crohn's DiseasePhase 2OPERANCT01276509

Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease

A Phase 2 study testing PF-00547659 SC injection in people with Crohn's Disease, run by Shire at 137 sites in 16 countries.

Completed

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

Official record
Search all trials

Trial summary

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
PF-00547659 SC injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
265 participants
Where
137 sitesin 16 countries
Study dates
6 Apr 2011to 9 Oct 2015
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX).
  • hsCRP greater than 3mg/L
  • Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening

Who cannot join

  • Pregnant or breast feeding
  • Short bowel syndrome due to multiple small bowel resections
  • Presence of a stoma

Trial locations and contacts

137 sites in 16 countries.

137 sites in 16 countries

United States69 sites

  • Albany Medical College

    Albany, New York, 12208

  • Connecticut Clinical Research Foundation

    Bristol, Connecticut, 06010

  • Life Medi-Research And Management

    Brooklyn, New York, 11206

  • CTRC Hospital - UNC Memorial Hospital

    Chapel Hill, North Carolina, 27514

  • North Carolina Memorial Hospital Endoscopy Center

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals Department of Pharmacy

    Chapel Hill, North Carolina, 27514

  • UNC Hospitals Endoscopy

    Chapel Hill, North Carolina, 27517

  • Charlottesville Gastroenterology Associates

    Charlottesville, Virginia, 22902

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Metropolitan Gastroenterology Group, PC - Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Heartland Medical Research (Administrative Only)

    Clive, Iowa, 50325

  • Iowa Digestive Disease Center

    Clive, Iowa, 50325

  • Iowa Endoscopy Center (Colonoscopy Only)

    Clive, Iowa, 50325

  • Surgery Center of Columbia

    Columbia, Missouri, 65201

  • The Offices of Dr. Vincent Armenio, M.D.

    East Providence, Rhode Island, 02914

  • Pharma Resource

    East Providence, Rhode Island, 02915

  • New York Hospital Queens

    Flushing, New York, 11355

  • Shands Endoscopy Center

    Gainesville, Florida, 32608

  • Shands Hospital at the University of Florida

    Gainesville, Florida, 32610

  • Shands Medical Plaza

    Gainesville, Florida, 32610

  • Long Island Clinical Research Associates, LLP

    Great Neck, New York, 11021

  • Nassau Gastroenterology Associates Office Based Surgery

    Great Neck, New York, 11021

  • Nassau Gastroenterology Associates, P.C.

    Great Neck, New York, 11021

  • North Shore Primary Care, P.C.

    Great Neck, New York, 11021

  • Hillsborough Campus

    Hillsborough, North Carolina, 27278

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Gastroenterology Specialists of Arkansas

    Jonesboro, Arkansas, 72401

  • UCSD Medical Center-Thornton Hospital

    La Jolla, California, 92037

  • Clinical Research of the Rockies

    Lafayette, Colorado, 80026

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Little Rock Diagnostic Clinic, P.A.

    Little Rock, Arkansas, 72205

  • Audrain Medical Center

    Mexico, Missouri, 65265

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Miami Hospital and Clinic

    Miami, Florida, 33136

  • University of Miami Hospital

    Miami, Florida, 33136

  • University of Miami

    Miami, Florida, FL 33136

  • Minneapolis Heart Institute, West Health Campus

    Minneapolis, Minnesota, 55404

  • Noran Neurology Clinic

    Minneapolis, Minnesota, 55407

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Beth Israel Medical Center - Phillip Ambulatory Care Center

    New York, New York, 10003

  • East side Endoscopy, LLC (for colonscopy testing only)

    New York, New York, 10010

  • Lenox Hill Endoscopy Center

    New York, New York, 10075

  • Community Clinical Trials

    Orange, California, 92868

  • Gastro Diagnostics

    Orange, California, 92868

  • Cirtus Ambulartory Surgery Center

    Orlando, Florida, 32806

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Pasadena Gastroenterology Associates, P.A. dba Digestive Health Center

    Pasadena, Texas, 77505

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Consulting Radiology (Xray testing only)

    Plymouth, Minnesota, 55446

  • Minnesota Gastroenterology, P.A.

    Plymouth, Minnesota, 55446

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Bayside Endoscopy Center

    Providence, Rhode Island, 02905

  • Inland Gastroenterology Medical Associates, Inc.

    Redlands, California, 92374

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of Utah HSC

    Salt Lake City, Utah, 84132

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Barnes-Jewish Hospital - Investigational Drug Services

    St Louis, Missouri, 63110

  • Center for Advanced Medicine

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado, 80229

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Surgical Centers of Michigan

    Troy, Michigan, 48098

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

  • GI Associates

    Wauwatosa, Wisconsin, 53226

  • BioMark Research Inc.

    Whittier, California, 90603

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

  • University of Massachusetts Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

France8 sites

  • CHU Amiens Hopital Nord Service d'Hepato-Gastroenterologie

    Amiens, 80054

  • Hopital Saint-Andre

    Bordeaux, 33075

  • Hopital Beaujon- Essais cliniques

    Clichy, 92110

  • Hopital de l'Archet 2 - CHU de Nice

    Nice, 06202

  • Hopital Cochin-Essais Cliniques

    Paris, 75014

  • Hopital Charles Nicolle

    Rouen, 76031

  • Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

Germany8 sites

  • Charite - Campus Berlin Mitte Medizinische Klinik

    Berlin, 10117

  • Krankenhaus Martha-Maria Halle-Doelau gGmbH

    Halle, 06120

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitaetsfrauenklinikum Schleswig-Holstein Medizinische Klinik I, Gastroenterologie/Hepatologie

    Lübeck, 23538

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Universitaetsklinikum Regensburg

    Regensburg, 93042

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitaetklinikum Ulm

    Ulm, 89081

Other trials in Germany

Japan7 sites

  • Aichi Medical University Hospital

    Aichi, 480-1195

  • Chiba University Hospital

    Chiba, 260-8677

  • National Hospital Organization Hirosaki National Hospital

    Hirosaki, Aomori, 036-8545

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • National Hospital Organization Takasaki General Medical Center

    Takasaki, Gunma, 370-0829

Other trials in Japan

South Korea7 sites

  • Pusan National University Hospital

    Busan, 602-739

  • Yeungnam University Hospital

    Daegu, 705-717

  • Seoul National University Hospital

    Seoul, 110-744

  • Kangbuk Samsung Hospital

    Seoul, 110-746

  • Yonsei University College of Medicine, Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Spain6 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitari Bellvitge

    Barcelona, 08907

  • Hospital Universitario de La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Corporacio Sanitaria Parc Tauli de Sabadell

    Sabadell, 08208

Other trials in Spain

Belgium4 sites

  • UZ Gasthuisberg

    Leuven, B-3000

  • Centre Hospitalier Universitaire de Liege

    Liège, 4000

  • Centre Hospitalier Universitaire de Liège - Labo Biologie Clinique

    Liège, 4000

  • Centre Hospitalier de Mouscron

    Mouscron, 7700

Other trials in Belgium

Canada4 sites

  • Oshawa Clinic

    Oshawa, Ontario, L1H 1B9

  • Vancouver Coastal Health - Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Vancouver Coastal Health - Vancouver Hospital

    Vancouver, British Columbia, V5Z 1M9

  • Toronto Digestive Disease Associates Inc.

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Poland4 sites

  • Szpital Uniwersytecki nr 2 im dr. Jana Bizieta w Bydgoszczy Centrum Endoskopii Zabiegowej

    Bydgoszcz, 85-168

  • Centrum Medyczne-Szpital Swietej Rodziny Sp. z o.o.

    Lodz, 90-302

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych w Warszawie

    Warsaw, 02-507

  • Lexmedica

    Wroclaw, 53-114

Other trials in Poland

Serbia4 sites

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Centre Bezanijska Kosa

    Belgrade, 11080

  • Clinical Center Nis Clinic for Gastroenterology and Hepatology

    Niš, 18000

  • Clinical Hospital Center Zemun

    Zemun, 11080

Other trials in Serbia

Slovakia4 sites

  • Gastroentero-Hepatologicke centrum THALION, LAMA MEDICAL CARE s.r.o.

    Bratislava, 831 04

  • Medak s.r.o.

    Bratislava, 851 01

  • Gastroenterologicke a hepatologicke centrum Nitra, KM Management spol. s r.o.

    Nitra, 949 01

  • Synergy group, a.s.

    Nové Mesto nad Váhom, 915 01

Other trials in Slovakia

Netherlands3 sites

  • Academic Medical Center

    Amsterdam, North Holland, 1105 AZ

  • University Medical Center Groningen (UMCG)

    Groningen, Provincie Groningen, 9713GZ

  • Maastricht University Medical Center

    Maastricht, 6229 HX

Other trials in Netherlands

Norway3 sites

  • Asker And Baerum Hospital

    Gjettum, 1346

  • Oslo Universitetssykehus

    Oslo, 0424

  • Lovisenberg Diakonale Sykehus

    Oslo, 0440

Other trials in Norway

South Africa3 sites

  • Kingsbury Hospital

    Cape Town, Western Cape, 7708

  • Parklands Medical Centre

    Durban, KwaZulu-Natal, 4091

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193

Other trials in South Africa

Bulgaria2 sites

  • 4-MHAT

    Sofia, 1000

  • MBAL Sofiamed OOD,Otdelenie po gastroenterologia

    Sofia, 1979

Other trials in Bulgaria

Austria1 site

  • AKH Wien Universitaetsklinik fuer Innere Medizin III

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Conditions
Crohn's Disease
Being tested
PF-00547659 SC injection
Keywords
Crohn's disease Safety Efficacy Pharmacokinetics Pharmacodynamics Crohn's Disease Activity Index (CDAI)
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-00547659 SC injectionDrug

    Placebo delivered SC, 3 doses separated by 4 weeks

  • PF-00547659 SC injectionDrug

    Drug dose level 1 delivered SC, 3 doses separated by 4 weeks

  • PF-00547659 SC injectionDrug

    Drug dose level 2 delivered SC, 3 doses separated by 4 weeks

  • PF-00547659 SC injectionDrug

    Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

Study groups in NCT01276509
Study groupRoleWhat they receive
Placebo-SC InjectionPlacebo comparatorPlacebo delivered SC, 3 doses separated by 4 weeks.
Receives: Drug: PF-00547659 SC injection
Drug Dose level 1- SC injectionExperimentalDrug dose level 1 delivered SC, 3 doses separated by 4 weeks.
Receives: Drug: PF-00547659 SC injection
Drug Dose level 2-SC injectionExperimentalDrug dose level 2 delievered SC, 3 doses separated by 4 weeks.
Receives: Drug: PF-00547659 SC injection
Drug Dose level 3- SC injectionExperimentalDrug dose level 3 delivered SC, 3 doses separated by 4 weeks.
Receives: Drug: PF-00547659 SC injection

What is being measured

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

  1. Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate

    Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.

    Measured: Week 8 and week 12

Secondary outcomes (12)

  1. Safety and Tolerability of PF-00547659 Dose Levels Versus Placebo

    Number of participants with adverse events (AEs), withdrawals due to AEs and Serious AEs (SAEs) were reported.

    Measured: Week 0-12

  2. Number of Adverse Events (AEs) - PF-00547659 Dose Levels Versus Placebo

    Number of adverse events (all causalities and treatment related) was reported between the investigational product groups and the placebo group.

    Measured: Week 0-12

  3. Percentage of Participants With a Crohn's Disease Activity Index (CDAI) Remission

    Percentage of participants with a CDAI remission (defined as a CDAI reduction to <150 points).

    Measured: Weeks 8 and week 12

  4. Crohn's Disease Activity Index (CDAI)-70 Response Rates Over Time

    Percentage of participants with Crohn's Disease Activity Index (CDAI)-70 response were reported.

    Measured: Week 2, 4, 6, 8, 10 and 12

  5. Crohn's Disease Activity Index (CDAI) -100 Response Rates Over Timer

    Percentage of participants with Crohn's Disease Activity Index (CDAI)-100 response were reported.

    Measured: Week 2, 4, 6, 8, 10 and 12

  6. Immunogenicity Assessment of Anti-drug Antibodies (ADAs)

    Confirmed cumulative incidence of anti-drug antibodies development to PF-00547659

    Measured: Day 1, Week 4, Week 8, Week 12, Week 20, Week 28, Week 36

  7. The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to area under the concentration-time profile (AUC), clearance (CL) and half life were estimated using data pooled from both typical and additional PK groups. AUCinf is area under the concentration time profile from time zero extrapolated to infinite time.

    Measured: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

  8. The Pharmacokinetics (PK) of Total PF-00547659 - Area Under the Concentration Time Profile From Time Zero to Time Tau (AUCtau)

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. AUCtau is area under the concentration time profile from time zero to time tau, the dosing interval, where tau = 672 hours (4 weeks)

    Measured: Day 1, 14, and 28

  9. The Pharmacokinetics (PK) of Total PF-00547659 - Maximum Observed Concentration (Cmax)

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Cmax is maximum observed concentration.

    Measured: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

  10. The Pharmacokinetics (PK) of Total PF-00547659 - Time for Cmax (Tmax)

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Tmax is time for Cmax.

    Measured: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

  11. The Pharmacokinetics (PK) of Total PF-00547659 - Terminal Half Life (Thalf)

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. Thalf is terminal half life.

    Measured: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

  12. The Pharmacokinetics (PK) of Total PF-00547659 - Apparent Clearance (CL/F)

    The Pharmacokinetics (PK) of total PF-00547659 was characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life were estimated using data pooled from both typical and additional PK groups. CL/F is apparent clearance.

    Measured: Day 1, 14, 28, 42, 56, 70, 84, 112, 140, 168, 196, 224 and 252

Timeline

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

  1. First posted13 Jan 2011 (estimated)
  2. Study start6 Apr 2011
  3. Primary completion7 Feb 2014
  4. Study completion9 Oct 2015

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01276509
Sponsor's protocol ID
A7281006
Other IDs
2010-023437-30, OPERA
Acronym
OPERA
Status last verified
May 2021
First submitted
12 Jan 2011
Last updated
3 Jun 2021
Data monitoring committee
Yes

Publications

  • Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.

    PubMed 32013314

  • Sandborn WJ, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Reinisch W, Hebuterne X, Park DI, Schreiber S, Nayak S, Ahmad A, Banerjee A, Brown LS, Cataldi F, Gorelick KJ, Cheng JB, Hassan-Zahraee M, Clare R, D'Haens GR. Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study. Gut. 2018 Oct;67(10):1824-1835. doi: 10.1136/gutjnl-2016-313457. Epub 2017 Oct 5.

    PubMed 28982740

  • Hassan-Zahraee M, Banerjee A, Cheng JB, Zhang W, Ahmad A, Page K, von Schack D, Zhang B, Martin SW, Nayak S, Reddy P, Xi L, Neubert H, Fernandez Ocana M, Gorelick K, Clare R, Vincent M, Cataldi F, Hung K. Anti-MAdCAM Antibody Increases ss7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):77-86. doi: 10.1093/ecco-jcc/jjx121.

    PubMed 28961803

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-00547659 SC injection in people with Crohn's Disease, run by Shire at 137 sites in 16 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 3 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, France, Germany, Japan, South Korea and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 13 Apr 2017). 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?

Percentage of Participants With Crohn's Disease Activity Index (CDAI) 70 Response Rate (time frame: Week 8 and week 12). 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 NCT01276509, which also lists 3 linked publications.

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 3 Jun 2021.

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