An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia

PHASE3CompletedINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

May 2, 2016

Primary Completion Date

January 5, 2021

Study Completion Date

January 5, 2021

Conditions
Erythrocyte TransfusionBeta-Thalassemia
Interventions
DRUG

Luspatercept

Subjects will start with luspatercept at 1 mg/kg dose level.

OTHER

Placebo

Placebo, Subcutaneous, every 21 days.

Trial Locations (76)

500

Changhua Christian Hospital, Changhua

807

Kaohsiung Medical University Hospital, Kaohsiung City

1006

Bone Marrow Transplant Center, Tunis

1008

Aziza Othmana Hospital, Tunis

1089

Military Hospital of Tunis, Tunis

1756

Specialized Hospital for Active Treatment of Haematological Diseases - Sofia, Sofia

2031

Prince of Wales Hospital, Randwick

2050

Royal Prince Alfred Hospital, Camperdown

3168

Monash Medical Centre, Clayton

4002

University Mulitiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv

4031

University Hospital Farhat Hached, Sousse

4101

Mater Hospital Brisbane, South Brisbane

5000

Royal Adelaide Hospital Institute of Medical and Veterinary Science, Adelaide

6009

Sir Charles Gairdner Hospital, Nedlands

9010

Multiprofile Hospital for Active Treatment Sveta Marina EAD, Varna

10002

National Taiwan University Hospital, Taipei, Zhongzheng Dist.

10043

Azienda Ospedaliero Universitaria S. Luigi Gonzaga, Orbassano

10065

Weill Cornell Medical College, New York

10330

Chulalongkorn University Faculty of Medicine - King Chulalongkorn Memorial Hospital, Bangkok

10700

Siriraj Hospital Mahidol University, Bangkok

10990

Hospital Pulau Pinang c/o Penang Medical College, George Town

11527

General Hospital Georgios Gennimatas of Athens, Athens

13385

Hopitaux de La Timone, Marseille

16128

Ente Ospedaliero Ospedali Galliera - Centro della Microcitemia e delle Anemie Congenite, Genoa

18101

HaEmek Medical Center, Haïfa (Afula)

19104

Hospital of the University of Pennsylvania, Philadelphia

20122

Fondazione Ca Granda IRCCS Ospedale Maggiore, Milan

22100

Galilee Medical Center, Nahariya

26500

University General Hospital of Patras, Rio Patras

30990

Hospital Raja Permaisuri Bainun, Ipoh

33343

Mersin University Medical Faculty, Mersin

34093

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi, Istanbul

35100

Ege Universitesi Tip Fakultesi Hastanesi, Izmir

37134

Azienda Ospedaliera Universitaria Integrata Di Verona, Verona

40447

China Medical University Hospital, Taichung

44124

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant'Anna, Ferrara

49100

Rabin Medical Center, Petah Tikva

50200

Chiang Mai University - Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

54642

Hippokration Hospital, Thessaloniki

Local Institution - 404, Thessaloniki

59000

GH de Institut Catholique St. VincentHématologie, Lille

59100

University Malaya Medical Centre, Kuala Lumpur

60611

Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago

72100

Presidio Ospedaliero Antonio Perrino, Brindisi

75015

Hospital of Necker, Paris

80100

Hospital Sultanah Aminah, Johor Bahru

80131

Seconda Universita Degli Studi Di Napoli, Naples

AORN A Cardarelli, Napoli

84101

Soroka University Medical Centre, Beersheba

88586

Queen Elizabeth Hospital, Kota Kinabalu

90027

Children's Hospital of Los Angeles, Los Angeles

90146

Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah Medical Center, Jerusalem

93586

Hospital Umum Sarawak, Kuching

94010

Hopital Henri Mondor, Créteil

94609

Children's Hospital and Research Center at Oakland, Oakland

3109601

Rambam Health Corporation, Haifa

02115

Boston Children's Hospital, Boston

M5G 2C4

University Health Network, Toronto

115 26

Laiko General Hospital of Athens, Ampelokipi - Athens

Local Institution - 405, Ampelokipi - Athens

115 27

"General Children's Hospital Agia Sophia", Athens

09121

Universita degli Studi di Cagliari - ASL8, Cagliari

Unknown

Chronic Care Center, Beirut

05460

Hospital Sultanah Bahiyah, Alor Star

01130

Acibadem Adana Hospital, Adana

01330

Cukurova University Medical Faculty Balcali Hospital, Adana

Local Institution - 524, Adana

01660

Hacettepe Universitesi, Ankara

07100

Antalya Egitim Arastirma, Antalya

LS9 7TF

St James University Hospital, Leeds

E1 1BB

Barts Health NHS Trust - The Royal London Hospital, London

N19 5NF

Whittington Hospital, London

WC1E 6AU

University College Hospital Trust, London Bloomsbury

M13 9WL

Manchester Royal Infirmary, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA

INDUSTRY

lead

Celgene

INDUSTRY

NCT02604433 - An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Adults Who Require Regular Red Blood Cell Transfusions Due to Beta (β) Thalassemia | Biotech Hunter | Biotech Hunter