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Pulmonary Arterial HypertensionPhase 3SERAPHIN OLNCT00667823

Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

A Phase 3 study testing Macitentan in people with Pulmonary Arterial Hypertension, run by Actelion at 158 sites in 36 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

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Macitentan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
158 sitesin 36 countries
Study dates
17 Oct 2008to 7 Dec 2020
Phase
Phase 3
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Signed informed consent prior to initiation of any study-mandated procedure.
  • Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
  • Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Who cannot join

  • Any major violation of protocol AC 055 302/SERAPHIN.
  • Pregnancy or breast-feeding.
  • AST and/or ALT > 3 times the upper limit of the normal range.
  • Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
  • Known hypersensitivity to ACT 064992 or any of the excipients.

Trial locations and contacts

158 sites in 36 countries.

158 sites in 36 countries

United States39 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease

    Atlanta, Georgia, 30322

  • Pulmonary & Critical Care of Atlanta

    Atlanta, Georgia, 30342-1713

  • University of Colorado CARDIAC AND VASCULAR CENTER

    Aurora, Colorado, 80045-2548

  • University of Maryland School of Medicine; Division of Cardiology

    Baltimore, Maryland, 21201-1544

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249-0001

  • Pulmonary/Critical Care Division/Tufts New England Medical Center

    Boston, Massachusetts, 02111-1552

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston University School of Medicine

    Boston, Massachusetts, 02118

  • University of Chicago

    Chicago, Illinois, 60637-1432

  • University of Cincinnati Ohio Heart Health Center

    Cincinnati, Ohio, 45219-2906

  • Ohio State University, Div. of Pul. & Critical Care

    Columbus, Ohio, 43210

  • University of Texas Medical Center - St. Paul University

    Dallas, Texas, 75390-8550

  • Atlanta Institute for Medical Research

    Decatur, Georgia, 30030

  • Harper Univ. Hospital/ Wayne State University

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710-0001

  • University of Florida - Division of Pulmonology

    Gainesville, Florida, 32610

  • Baylor College of Medicine and the Methodist Hospital,

    Houston, Texas, 77030

  • University of Texas Houston Health Center

    Houston, Texas, 77030

  • University of Iowa, Pulmonary Hypertension Program

    Iowa City, Iowa, 52242-1081

  • Mayo Clinic, Jacksonville

    Jacksonville, Florida, 32259

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • University of California, San Diego

    La Jolla, California, 92037

  • GLVA Healthcare Center

    Los Angeles, California, 90073

  • Kentuckiana Pulmonary Associate, PLLC

    Louisville, Kentucky, 40202

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53125

  • Intermountain Med Ctr- Pulm Dept Heart and Lung Ctr

    Murray, Utah, 84157-5701

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • University of NJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903-0010

  • Louisiana State University Health Sciences Center

    New Orleans, Louisiana, 70112-1393

  • Columbia University Medical Center - Pediatric Cardiology

    New York, New York, 10032

  • Sentara Hospitals T/A Sentara Cardiovascular Research Intitute

    Norfolk, Virginia, 23507-1904

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Arizona Pulmonary Specialists

    Phoenix, Arizona, 85012

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Maine Medical Center

    Portland, Maine, 04102-3134

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Washington University School of Medicine

    St Louis, Missouri, 63110-1010

  • Liu Center for Pulmonary Hypertension

    Torrance, California, 90502-2006

Other trials in United States

Germany13 sites

  • Unfallkrankenhaus Berlin, Klinik für Innere Medizin

    Berlin, 12683

  • Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie

    Cologne, 50924

  • Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus

    Dresden, 01307

  • Universitätsklinikum Essen, Klinik für Kardiologie , Zentrum für Innere Medizin

    Essen, 45122

  • Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med. / Pneumologie

    Giessen, 35392

  • Universität Greifswald / Klinik für Innere Medizin B,

    Greifswald, 17475

  • Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie

    Hamburg, 20246

  • Medizinische Hochschule Hannover / Klinik für Pneumologie

    Hanover, 30625

  • Thoraxklinik am Universitätsklinikum Heidelberg

    Heidelberg, 69126

  • Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V

    Homburg/Saar, 66421

  • Universtätsklinik Leipzig

    Leipzig, 04103

  • Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie

    Munich, 81377

  • Universitatsklinikum Regensburg/Innere Medizin II

    Regensburg, 93053

Other trials in Germany

Russia12 sites

  • Municipal Health Care Institution Kemerovo Cardiology Dispensary

    Kemerovo, 650002

  • Federal State Institution "State Scientific Research Centre of Preventive Medicine" of Rosmedtechnology

    Moscow, 101990

  • Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"

    Moscow, 105077

  • State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"

    Moscow, 117049

  • Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"

    Moscow, 121552

  • State Educational Institution "St Petersburg Medical Academy of Postgraduate Education" of Federal Agency of Public Health and Social Development

    Saint Petersburg, 193015

  • State Educational Institution of High Professional Education "St Petersburg State Medical

    Saint Petersburg, 197 022

  • Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology

    Saint Petersburg, 197341

  • State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch

    Tomsk, 634012

  • Tomsk Regional Clinical Hospital / Pulmonology Unit

    Tomsk, 634063

  • Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"

    Yaroslavl, 150 003

  • Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)

    Yekaterinburg, 620102

Other trials in Russia

Argentina8 sites

  • Sanatorio Otamendi y Miroli S.A.

    Buenos Aires, Ciudad Autonoma, C1121ABL

  • Hospital Britanico

    Buenos Aires, Ciudad Autonoma, C1280AEB

  • Sanatorio MITRE

    Buenos Aires, C1039AAO

  • Fundacion Favaloro

    Buenos Aires, C1093AAS

  • Htal Italiano Cordoba

    Córdoba, X5004BAL

  • Htla privado de Cordoba

    Córdoba, x5016keh

  • Instituto Cardiologia Corrientes

    Corrientes, W3400AMZ

  • Hospital Italiano - Garibaldi de Rosario

    Santa Fe, S2001ODA

Other trials in Argentina

China8 sites

  • Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department

    Beijing, 100029

  • Peking Union Medical College Hospital, Rheumatology Department

    Beijing, 100032

  • Guangdong General Hospital, Cardiology Department

    Guangzhou, 510080

  • Jiangsu Province Hospital - Pneumology Department

    Nanjing, 210029

  • Renji Hospital, Rheumatology Department

    Shanghai, 200001

  • Zhongshan Hospital Fudan University, Cardiology Department

    Shanghai, 200032

  • Renji Hospital, Cardiology Department

    Shanghai, 200127

  • Shanghai Pulmonary Hospital Department of Pulmonary Circulation

    Shanghai, 200433

Other trials in China

India6 sites

  • Life Care Institute of Medical Science & Research, Ahmedabad

    Ahmedabad, 382428

  • Care Hospital

    Hyderabad, 500001

  • Seth GS Medical College & King Edward VII Memorial (KEM) Hospital / Department Of Cardiology

    Mumbai, 400012

  • P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine

    Mumbai, 400016

  • G B Pant Hospital & Maulana Azad Medical College

    New Delhi, 110 002

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, 411 004

Other trials in India

Israel6 sites

  • Rambam Health Care Campus / Division of Medicine, Institute of Pulmonology

    Haifa, 31096

  • Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division

    Haifa, 34362

  • Rabin Medical Center - Belinson campus - Pulmonary Institute

    Petach - Tikvah, 49100

  • Pulmonary Institute, Kaplan Medical Center

    Rehovot, 76100

  • Sourasky Medical Center - Division of Pulmonary Medicine and Allergy

    Tel Aviv, 64239

  • The pulmonary institute Sheba Medical centre

    Tel HaShomer, 52621

Other trials in Israel

Canada4 sites

  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • London Health Sciences Centre

    London, Ontario, N6C 2R5

  • L'Hopital Laval

    Sainte-Foy, Quebec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

Hungary4 sites

  • Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)

    Budapest, 1096

  • "Semmelweis Egyetem, Pulmonológiai Klinika"

    Budapest, 1125

  • University of Pecs, Medical School/Heart Institute and 1st Department of Internal Medicine

    Pécs, 7624

  • University of Szeged Albert Szent-Gyorgyi Medical & Pharmaceutical Center

    Szeged, 6720

Other trials in Hungary

South Africa4 sites

  • Tread Research

    Cape Town, 7505

  • Chris Hani Baragwanath Hospital, Department of Cardiology

    Johannesburg, 2013

  • Netcare Milpark Hospital,Center for Chest Disease

    Johannesburg, 2193

  • Block 4, Vergelegen Medi-Clinic

    Somerset West, 7130

Other trials in South Africa

Thailand4 sites

  • Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,

    Bangkok, 10400

  • Siriraj Hospital, Mahidol University

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology

    Chiang Mai, 50200

  • Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University

    Khon Kaen, 40002

Other trials in Thailand

Australia3 sites

  • St. Vincent's Hospital

    Darlinghurst, 2010

  • The Alfred Hospital

    Melbourne, 3004

  • Royal Brisbane Hospital

    Sunshine Coast, 4558

Other trials in Australia

Belarus3 sites

  • Republican reserach - Pratical Centre of Cardiology

    Minsk, 220036

  • Minsk Regional Clinical Hospital

    Minsk, 223041

  • Vitebsk Regional Clinical Hospital

    Vitebsk, 210037

Other trials in Belarus

Chile3 sites

  • Hospital del Torax

    Santiago, 7500691

  • Pontificia Universidad Catolica de Chile

    Santiago, 833034

  • Hospital San Juan de Dios

    Santiago, 8350488

Other trials in Chile

France3 sites

  • Hosp Bicetre - Dept Pulmo & Resp Intensive Care

    Le Kremlin-Bicêtre, 94275

  • Hopital Arnaud de Villeneuve Service des Maladies Respiratoires

    Montpellier, 34295

  • Hopital Haut-Leveque-Maison du Haut-Leveque

    Pessac, 33604

Other trials in France

Peru3 sites

  • Hospital Alberto Sabogal Sologuren - EsSALUD

    Callao, Callao 02

  • Clinica Medica Cayetano Heredia

    Lima, 31

  • Instituto de Enfermedades Respiratorias

    Lima, 32

Other trials in Peru

Poland3 sites

  • Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ

    Krakow, 31-202

  • Cardiology Otwock Priv

    Otwock, 05-400

  • III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego

    Zabrze, 41-800

Other trials in Poland

Serbia3 sites

  • University Children's Hospital (UNIVERZITETSKA DECJA KLINKIKA)

    Belgrade, 11000

  • University Clinical Center of Serbia/ Institute for Lung Diseases and Tuberculosis

    Belgrade, 11000

  • Zemun Clinical Hospital (Klinicko-bolnicki centar Zemun) / Department of Cardiology

    Belgrade, 11080

Other trials in Serbia

Ukraine3 sites

  • Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid

    Dnipro, 49060

  • Danylo Galytskyi Lviv State Medical University

    Lviv, 79010

  • Odessa State Medical University, Military-medical Clinical Center of the South region

    Odesa, 65044

Other trials in Ukraine

Colombia2 sites

  • Fundacion Clinica Shaio

    Bogotá

  • Fundacion Cardiovascular de Colombia

    Floridablanca, Santander Department

Other trials in Colombia

Italy2 sites

  • IRCCS Policlinico San Matteo Policlinico / Dipartimento di Cardiologia

    Pavia, 207100

  • Policlinico Umberto I, Cardiologia

    Roma, 00161

Other trials in Italy

Mexico2 sites

  • Instituto Nacional de Cardiología (INC) Ignacio Chávez

    Mexico City, 14080

  • Unidad de Investigación Clinica en Medicina

    Monterrey, 64718

Other trials in Mexico

Netherlands2 sites

  • VU Medisch Centrum, Dept. Pulmonology 4A 48

    Amsterdam, 1081 HV

  • St. Antonius ziekenhuis

    Nieuwegein, 3435 CM

Other trials in Netherlands

Romania2 sites

  • Institutul de boli cardiovasculare / Clinica de Cardiologie

    Bucharest, 022328

  • Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie

    Bucharest, 050159

Other trials in Romania

Singapore2 sites

  • National University Hospital/ The Heart Institute

    Singapore, 119228

  • National Heart Centre (Nhc) Singapore

    Singapore, 169609

Other trials in Singapore

Slovakia2 sites

  • National Institute of Cardiovascular Diseases (Slovenska zdravotnicka univerzita) / Faculty of Medical Specialty Studies (Fakulta zdravotnickych speci

    Bratislava, 833 48

  • Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií)

    Bratislava, 833 48

Other trials in Slovakia

Sweden2 sites

  • University Hospital of Lund, Dept. of Cardiology

    Lund, 221 85

  • Uppsala University Hospital, Cardiology

    Uppsala, 751 85

Other trials in Sweden

Taiwan2 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department

    Taipei, 100

Other trials in Taiwan

Austria1 site

  • Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology

    Vienna, 1090

Other trials in Austria

Belgium1 site

  • University Hospital Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Bulgaria1 site

  • Mhat Nat Card Hosp - Pediatric Clinic

    Sofia, BG, 1309

Other trials in Bulgaria

Croatia1 site

  • Clinical Hospital Center

    Rijeka, 51 000

Other trials in Croatia

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, 00290

Other trials in Finland

Hong Kong1 site

  • Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics

    Hong Kong

Other trials in Hong Kong

Malaysia1 site

  • Institut Jantung Negara (National Heart Institute)

    Kuala Lumpur, 50400

Other trials in Malaysia

United Kingdom1 site

  • Royal Free Hospital

    London, NW3 2QG

Other trials in United Kingdom

About this study

Official title: Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

Being tested
Macitentan
Keywords
SERAPHIN, Pulmonary Arterial Hypertension, ACT-064992
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

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

  • MacitentanDrug

    Also called ACT-064992

    Tablet, oral administration, 10 mg dose once daily

Study groups in NCT00667823
Study groupRoleWhat they receive
ACT-064992ExperimentalACT-064992
Receives: Drug: Macitentan

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.

    Measured: Up to 28 days after study treatment discontinuation (Up to 12 years)

  2. Number of Participants With Death up to 28 Days After Study Treatment Discontinuation

    Number of participants with deaths up to 28 days after study treatment discontinuation were reported.

    Measured: Up to 28 days after study treatment discontinuation (Up to 12 years)

  3. Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.

    Measured: Up to 28 days after study treatment discontinuation (Up to 12 years)

  4. Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment

    Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

    Measured: Up to 28 days after study treatment discontinuation (Up to12 years)

  5. Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation

    Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (>) 3*upper limit of normal (ULN) or aspartate aminotransferase (AST) >3* ULN, ALT >5* ULN or AST >5*ULN, ALT >8*ULN or AST >8*ULN, total bilirubin (TBIL) >2*ULN, ALT >3*ULN or AST >3*ULN and TBIL >2*ULN at any time were reported.

    Measured: Up to 28 days after study treatment discontinuation (Up to12 years)

  6. Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation

    Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were <=80 grams/Liter (g/L), <=100g/L, decrease from baseline >=20 g/L, and decrease from baseline >=50 g/L.

    Measured: Up to 28 days after treatment discontinuation (Up to 12 years)

Timeline

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

  1. First posted28 Apr 2008 (estimated)
  2. Study start17 Oct 2008
  3. Primary completion7 Dec 2020
  4. Study completion7 Dec 2020

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00667823
Sponsor's protocol ID
AC-055-303
Acronym
SERAPHIN OL
Status last verified
Mar 2025
First submitted
24 Apr 2008
Last updated
30 Mar 2025
Data monitoring committee
Yes

Publications

  • Souza R, Delcroix M, Galie N, Jansa P, Mehta S, Pulido T, Rubin L, Sastry BKS, Simonneau G, Sitbon O, Torbicki A, Boyanova N, Chamitava L, Stein C, Channick RN. Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension. Adv Ther. 2022 Sep;39(9):4374-4390. doi: 10.1007/s12325-022-02199-x. Epub 2022 Jul 12.

    PubMed 35819570

  • Krause A, Zisowsky J, Dingemanse J. Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension. Pulm Pharmacol Ther. 2018 Apr;49:140-146. doi: 10.1016/j.pupt.2018.02.005. Epub 2018 Feb 28.

    PubMed 29501590

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Macitentan in people with Pulmonary Arterial Hypertension, run by Actelion at 158 sites in 36 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 5 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 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Germany, Russia, Argentina, China and 31 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Feb 2022). 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation (time frame: Up to 28 days after study treatment discontinuation (Up to 12 years)). The study lists 6 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 NCT00667823, which also lists 2 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 30 Mar 2025.

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