ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)

PHASE3CompletedINTERVENTIONAL
Enrollment

272

Participants

Timeline

Start Date

December 12, 2016

Primary Completion Date

February 28, 2023

Study Completion Date

February 28, 2023

Conditions
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Interventions
BIOLOGICAL

Ravulizumab

All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to \<60 kilogram (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to \<100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.

BIOLOGICAL

Eculizumab

All treatments were given as IV infusions. Participants were administered induction doses of 600 mg followed by maintenance doses of 900 mg.

Trial Locations (120)

100

Research Site, Taipei

404

Research Site, Taichung

1200

Research Site, Brussels

3000

Research Site, Leuven

3500

Research Site, Hasselt

4020

Research Site, Linz

6000

Research Site, Perth

10330

Research Site, Bangkok

10408

Research Site, Goyang-si

10700

Research Site, Bangkok

10990

Research Site, George

11000

Research Site, Belgrade

13419

Research Site, Tallinn

15586

Research Site, Kota Bharu

16150

Research Site, Kota Bharu

16247

Research Site, Suwon

20122

Research Site, Milan

21565

Research Site, Incheon

26040

Research Site, Eskişehir

28040

Research Site, Madrid

28220

Research Site, Majadahonda

34295

Research Site, Montpellier

35015

Research Site, Daejeon

35033

Research Site, Rennes

36100

Research Site, Vicenza

41944

Research Site, Junggu

44033

Research Site, Ulsan

45122

Research Site, Essen

50006

Research Site, Changhua

50134

Research Site, Florence

52074

Research Site, Aachen

52727

Research Site, JinJoo

63100

Research Site, Ascoli Piceno

64460

Research Site, Monterrey

69310

Research Site, Pierre-Bénite

70403

Research Site, Tainan City

75185

Research Site, Uppsala

75475

Research Site, Paris

76104

Research Site, Fort Worth

80100

Research Site, Johor Bahru

80131

Research Site, Napoli

86021

Research Site, Poitiers

87042

Research Site, Limoges

88586

Research Site, Kota Kinabalu

89081

Research Site, Ulm

90033

Research Site, Los Angeles

90110

Research Site, Songkhla

90603

Research Site, Whittier

93586

Research Site, Kuching

96000

Research Site, Sibu

97002

Research Site, Hualien City

98000

Research Site, Miri

117997

Research Site, Moscow

119228

Research Site, Singapore

125284

Research Site, Moscow

152703

Research Site, Seoul

163045

Research Site, Arkhangelsk

183047

Research Site, Murmansk

185019

Research Site, Petrozavodsk

197022

Research Site, Saint Petersburg

344022

Research Site, Rostov-on-Don

410028

Research Site, Saratov

450005

Research Site, Ufa

610027

Research Site, Kirov

630091

Research Site, Novosibirsk

644013

Research Site, Omsk

656024

Research Site, Barnaul

664079

Research Site, Irkutsk

C1015ABO

Research Site, Buenos Aires

C1425AUM

Research Site, Buenos Aires

X5004BAL

Research Site, Córdoba

A-1090

Research Site, Vienna

Unknown

Research Site, Rio de Janeiro

Research Site, São Paulo

Research Site, Prague

Research Site, Tokorozawa-shi

Research Site, Tokyo

Research Site, Saint Petersburg

Research Site, Leeds

41253-190

Research Site, Salvador

05403-000

Research Site, São Paulo

T6G 2G3

Research Site, Edmonton

M4N 3M5

Research Site, Toronto

323 00

Research Site, Pilsen

113-8431

Research Site, Bunkyō City

113-8519

Research Site, Bunkyō City

812-8582

Research Site, Fukuoka

960-1295

Research Site, Fukushima

432-8580

Research Site, Hamamatsu

920-8641

Research Site, Kanazawa

806-8501

Research Site, Kitakyusyu-shi

343-8555

Research Site, Koshigaya-shi

860-8556

Research Site, Kumamoto

453-8511

Research Site, Nagoya

663-8501

Research Site, Nishinomiya-shi

503-8502

Research Site, Ogaki-shi

700-8558

Research Site, Okayama

701-1192

Research Site, Okayama

589-8511

Research Site, Osakasayama-shi

060-8543

Research Site, Sapporo

329-0498

Research Site, Shimotsuke-shi

160-0023

Research Site, Shinjuku-ku

160-8582

Research Site, Shinjuku-ku

565-0871

Research Site, Suita

470-1192

Research Site, Toyoake-shi

305-8576

Research Site, Tsukuba

641-8510

Research Site, Wakayama

80-214

Research Site, Gdansk

02-172

Research Site, Warsaw

561-712

Research Site, Jeonju

02841

Research Site, Seoul

03080

Research Site, Seoul

03722

Research Site, Seoul

04401

Research Site, Seoul

06591

Research Site, Seoul

07985

Research Site, Seoul

135-710

Research Site, Seoul

05505

Research Site, Songpa-gu

ML6 0JS

Research Site, Airdrie

SE5 9NU

Research Site, London

Sponsors
All Listed Sponsors
lead

Alexion Pharmaceuticals, Inc.

INDUSTRY