Phase
Condition
Proteinuria
Anemia
Hemoglobinuria, Paroxysmal
Treatment
Eculizumab
Ravulizumab
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Criteria For Patient Cohort Originally Enrolled in ALXN1210-PNH-301 Study: Inclusion Criteria: 1. Male or female ≥18 years of age. 2. PNH diagnosis confirmed by documented by high-sensitivity flow cytometry. 3. Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin <10 gram/deciliter), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of packed red blood cells (pRBC) transfusion due to PNH. 4. Lactate dehydrogenase (LDH) level ≥1.5 times the upper limit of normal at screening. 5. Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment. 6. Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab. 7. Willing and able to give written informed consent
Exclusion
and comply with study visit schedule. Exclusion Criteria: 1. Treatment with a complement inhibitor at any time. 2. History of bone marrow transplantation. 3. Body weight <40 kg. 4. Females who are pregnant, breastfeeding, or who have a positive pregnancy test at screening or Day 1. 5. Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater. 6. History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation. 7. Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleed, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, coexisting chronic anemia unrelated to PNH). Eligibility Criteria For Roll-over Cohort: 1. All participants regardless of age, who are currently receiving ALXN1210 IV in an ongoing ALXN1210 study in patients with PNH 2. Participants must be willing and able to give written informed consent and to comply with all Extension study visits and procedures, including the use of any data collection device(s) to directly record patient data 3. Females of childbearing potential and male patients with female partners of childbearing potential must use highly effective contraception continuing until at least 8 months after the last dose of ravulizumab.
Study Design
Study Description
Connect with a study center
Clinical Trial Site
Buenos Aires, C1425AUM
ArgentinaSite Not Available
Research Site
Buenos Aires, C1425AUM
ArgentinaSite Not Available
Clinical Trial Site
Caba,
ArgentinaSite Not Available
Clinical Trial Site
Córdoba,
ArgentinaSite Not Available
Research Site
Córdoba, X5004BAL
ArgentinaSite Not Available
Clinical Trial Site
Perth,
AustraliaSite Not Available
Research Site
Perth, 6000
AustraliaSite Not Available
Clinical Trial Site
Linz,
AustriaSite Not Available
Research Site
Linz, 4020
AustriaSite Not Available
Clinical Trial Site
Vienna,
AustriaSite Not Available
Research Site
Vienna, A-1090
AustriaSite Not Available
Research Site
Bruxelles, 1200
BelgiumSite Not Available
Clinical Trial Site
Hasselt,
BelgiumSite Not Available
Research Site
Hasselt, 3500
BelgiumSite Not Available
Clinical Trial Site
Leuven,
BelgiumSite Not Available
Research Site
Leuven, 3000
BelgiumSite Not Available
Clinical Trial Site
Belém,
BrazilSite Not Available
Research Site
Rio De Janeiro,
BrazilSite Not Available
Clinical Trial Site
Rio de Janeiro,
BrazilSite Not Available
Clinical Trial Site
Salvador,
BrazilSite Not Available
Research Site
Salvador, 41253-190
BrazilSite Not Available
Research Site
Sao Paulo,
BrazilSite Not Available
Clinical Trial Site
São Paulo, 05403-000
BrazilSite Not Available
Research Site
Edmonton, Alberta T6G 2G3
CanadaSite Not Available
Research Site
Toronto, Ontario M4N 3M5
CanadaSite Not Available
Clinical Trial Site
Edmonton,
CanadaSite Not Available
Clinical Trial Site
Toronto,
CanadaSite Not Available
Clinical Trial Site
Bogotá,
ColombiaSite Not Available
Clinical Trial Site
Cali,
ColombiaSite Not Available
Clinical Trial Site
Medellín,
ColombiaSite Not Available
Clinical Trial Site
Plzen,
CzechiaSite Not Available
Research Site
Plzeň, 323 00
CzechiaSite Not Available
Research Site
Prague,
CzechiaSite Not Available
Clinical Trial Site
Praha,
CzechiaSite Not Available
Clinical Trial Site
Tallinn,
EstoniaSite Not Available
Research Site
Tallinn, 13419
EstoniaSite Not Available
Clinical Trial Site
Poitiers, Vienne
FranceSite Not Available
Clinical Trial Site
Limoges,
FranceSite Not Available
Research Site
Limoges, 87042
FranceSite Not Available
Research Site
MONTPELLIER Cedex 5, 34295
FranceSite Not Available
Clinical Trial Site
Montpellier,
FranceSite Not Available
Clinical Trial Site
Paris,
FranceSite Not Available
Research Site
Paris Cedex 10, 75475
FranceSite Not Available
Research Site
Pierre Benite, 69310
FranceSite Not Available
Clinical Trial Site
Pierre-Bénite,
FranceSite Not Available
Research Site
Poitiers, 86021
FranceSite Not Available
Clinical Trial Site
Rennes,
FranceSite Not Available
Research Site
Rennes Cedex 9, 35033
FranceSite Not Available
Research Site
Aachen, 52074
GermanySite Not Available
Clinical Trial Site
Essen,
GermanySite Not Available
Research Site
Essen, 45122
GermanySite Not Available
Clinical Trial Site
Ulm,
GermanySite Not Available
Research Site
Ulm, 89081
GermanySite Not Available
Clinical Trial Site
Ascoli Piceno,
ItalySite Not Available
Research Site
Ascoli Piceno, 63100
ItalySite Not Available
Clinical Trial Site
Firenze,
ItalySite Not Available
Research Site
Firenze, 50134
ItalySite Not Available
Clinical Trial Site
Milano,
ItalySite Not Available
Research Site
Milano, 20122
ItalySite Not Available
Clinical Trial Site
Napoli,
ItalySite Not Available
Research Site
Napoli, 80131
ItalySite Not Available
Clinical Trial Site
Vicenza,
ItalySite Not Available
Research Site
Vicenza, 36100
ItalySite Not Available
Clinical Trial Site
Ogaki, Gifu-ken
JapanSite Not Available
Clinical Trial Site
Kanazawa, Ishikawa-Ken
JapanSite Not Available
Clinical Trial Site
Koshigaya, Saitama
JapanSite Not Available
Clinical Trial Site
Shinjuku, Tokyo-To
JapanSite Not Available
Clinical Trial Site
Bunkyo-ku,
JapanSite Not Available
Research Site
Bunkyo-ku, 113-8519
JapanSite Not Available
Clinical Trial Site
Bunkyō,
JapanSite Not Available
Clinical Trial Site
Bunkyō-Ku, 113-8431
JapanSite Not Available
Clinical Trial Site
Fukuoka,
JapanSite Not Available
Research Site
Fukuoka-Shi, 812-8582
JapanSite Not Available
Clinical Trial Site
Fukushima,
JapanSite Not Available
Clinical Trial Site
Fukushima-shi,
JapanSite Not Available
Research Site
Fukushima-shi, 960-1295
JapanSite Not Available
Clinical Trial Site
Hamamatsu,
JapanSite Not Available
Clinical Trial Site
Hamamatsu-shi,
JapanSite Not Available
Research Site
Hamamatsu-shi, 432-8580
JapanSite Not Available
Clinical Trial Site
Kanazawa-shi,
JapanSite Not Available
Research Site
Kanazawa-shi, 920-8641
JapanSite Not Available
Research Site
Kitakyusyu-shi, 806-8501
JapanSite Not Available
Clinical Trial Site
Koshigaya-shi,
JapanSite Not Available
Research Site
Koshigaya-shi, 343-8555
JapanSite Not Available
Clinical Trial Site
Kumamoto,
JapanSite Not Available
Research Site
Kumamoto-shi, 860-8556
JapanSite Not Available
Research Site
Nagoya-shi, 453-8511
JapanSite Not Available
Clinical Trial Site
Nishinomiya,
JapanSite Not Available
Clinical Trial Site
Nishinomiya-shi,
JapanSite Not Available
Research Site
Nishinomiya-shi, 663-8501
JapanSite Not Available
Clinical Trial Site
Ogaki-shi,
JapanSite Not Available
Research Site
Ogaki-shi, 503-8502
JapanSite Not Available
Clinical Trial Site
Okayama,
JapanSite Not Available
Clinical Trial Site
Okayama-city,
JapanSite Not Available
Clinical Trial Site
Okayama-shi,
JapanSite Not Available
Research Site
Okayama-shi, 700-8558
JapanSite Not Available
Clinical Trial Site
Osakasayama,
JapanSite Not Available
Clinical Trial Site
Osakasayama-shi,
JapanSite Not Available
Research Site
Osakasayama-shi, 589-8511
JapanSite Not Available
Clinical Trial Site
Sapporo,
JapanSite Not Available
Research Site
Sapporo-shi, 060-8543
JapanSite Not Available
Clinical Trial Site
Shimotsuke,
JapanSite Not Available
Clinical Trial Site
Shimotsuke-shi,
JapanSite Not Available
Research Site
Shimotsuke-shi, 329-0498
JapanSite Not Available
Clinical Trial Site
Shinagawa,
JapanSite Not Available
Clinical Trial Site
Shinagawa-Ku,
JapanSite Not Available
Clinical Trial Site
Shinjuku-Ku, 160-0023
JapanSite Not Available
Research Site
Shinjuku-ku, 160-0023
JapanSite Not Available
Clinical Trial Site
Suita,
JapanSite Not Available
Research Site
Suita, 565-0871
JapanSite Not Available
Clinical Trial Site
Suita-shi,
JapanSite Not Available
Clinical Trial Site
Tokorozawa,
JapanSite Not Available
Clinical Trial Site
Tokorozawa-shi,
JapanSite Not Available
Research Site
Tokorozawa-shi,
JapanSite Not Available
Research Site
Tokyo,
JapanSite Not Available
Clinical Trial Site
Toyoake-shi,
JapanSite Not Available
Research Site
Toyoake-shi, 470-1192
JapanSite Not Available
Clinical Trial Site
Toyohashi,
JapanSite Not Available
Clinical Trial Site
Tsukuba,
JapanSite Not Available
Research Site
Tsukuba-shi, 305-8576
JapanSite Not Available
Clinical Trial Site
Wakayama,
JapanSite Not Available
Clinical Trial Site
Wakayama-shi,
JapanSite Not Available
Research Site
Wakayama-shi, 641-8510
JapanSite Not Available
Clinical Trial Site
Yokohama,
JapanSite Not Available
Clinical Trial Site
Yokohama-City, 236-0004
JapanSite Not Available
Clinical Trial Site
Anyang-si,
Korea, Republic ofSite Not Available
Clinical Trial Site
Busan,
Korea, Republic ofSite Not Available
Clinical Trial Site
Daegu,
Korea, Republic ofSite Not Available
Clinical Trial Site
Daejeon,
Korea, Republic ofSite Not Available
Research Site
Daejeon, 35015
Korea, Republic ofSite Not Available
Research Site
Goyang-si, 10408
Korea, Republic ofSite Not Available
Clinical Trial Site
Incheon,
Korea, Republic ofSite Not Available
Research Site
Incheon, 21565
Korea, Republic ofSite Not Available
Clinical Trial Site
Jeonju,
Korea, Republic ofSite Not Available
Research Site
Jeonju-si, 561-712
Korea, Republic ofSite Not Available
Research Site
JinJoo, 52727
Korea, Republic ofSite Not Available
Clinical Trial Site
Jinju-si,
Korea, Republic ofSite Not Available
Research Site
Jung-gu, 41944
Korea, Republic ofSite Not Available
Clinical Trial Site
Seoul, 03722
Korea, Republic ofSite Not Available
Research Site
Seoul, 135-710
Korea, Republic ofSite Not Available
Research Site
Songpa-gu, 05505
Korea, Republic ofSite Not Available
Clinical Trial Site
Suwon-si, 16499
Korea, Republic ofSite Not Available
Research Site
Suwon-si, 16247
Korea, Republic ofSite Not Available
Clinical Trial Site
Ulsan,
Korea, Republic ofSite Not Available
Research Site
Ulsan, 44033
Korea, Republic ofSite Not Available
Clinical Trial Site
Miri, Sarawak
MalaysiaSite Not Available
Clinical Trial Site
Sibu, Sarawak
MalaysiaSite Not Available
Clinical Trial Site
Ampang,
MalaysiaSite Not Available
Research Site
George, 10990
MalaysiaSite Not Available
Clinical Trial Site
Johor Bahru,
MalaysiaSite Not Available
Research Site
Johor Bahru, 80100
MalaysiaSite Not Available
Clinical Trial Site
Kelantan,
MalaysiaSite Not Available
Clinical Trial Site
Kota Bahru, 16150
MalaysiaSite Not Available
Clinical Trial Site
Kota Bharu, 15586
MalaysiaSite Not Available
Research Site
Kota Bharu, 16150
MalaysiaSite Not Available
Clinical Trial Site
Kota Kinabalu,
MalaysiaSite Not Available
Research Site
Kota Kinabalu, 88586
MalaysiaSite Not Available
Clinical Trial Site
Kubang Kerian,
MalaysiaSite Not Available
Clinical Trial Site
Kuching,
MalaysiaSite Not Available
Research Site
Kuching, 93586
MalaysiaSite Not Available
Research Site
Miri, 98000
MalaysiaSite Not Available
Clinical Trial Site
Pulau Pinang,
MalaysiaSite Not Available
Research Site
Sibu, 96000
MalaysiaSite Not Available
Clinical Trial Site
Monterrey,
MexicoSite Not Available
Research Site
Monterrey, 64460
MexicoSite Not Available
Clinical Trial Site
Gdańsk,
PolandSite Not Available
Research Site
Gdańsk, 80-214
PolandSite Not Available
Clinical Trial Site
Warsaw,
PolandSite Not Available
Research Site
Warszawa, 02-172
PolandSite Not Available
Clinical Trial Site
Arkhangel'sk,
Russian FederationSite Not Available
Research Site
Arkhangelsk, 163045
Russian FederationSite Not Available
Clinical Trial Site
Barnaul,
Russian FederationSite Not Available
Research Site
Barnaul, 656024
Russian FederationSite Not Available
Clinical Trial Site
Bryansk,
Russian FederationSite Not Available
Clinical Trial Site
Dzerzhinsk,
Russian FederationSite Not Available
Clinical Trial Site
Irkutsk,
Russian FederationSite Not Available
Research Site
Irkutsk, 664079
Russian FederationSite Not Available
Clinical Trial Site
Kaluga,
Russian FederationSite Not Available
Clinical Trial Site
Kirov,
Russian FederationSite Not Available
Research Site
Kirov, 610027
Russian FederationSite Not Available
Clinical Trial Site
Krasnodar, 350007
Russian FederationSite Not Available
Clinical Trial Site
Krasnoyarsk, 660022
Russian FederationSite Not Available
Clinical Trial Site
Moscow, 125167
Russian FederationSite Not Available
Research Site
Moscow, 117997
Russian FederationSite Not Available
Clinical Trial Site
Murmansk,
Russian FederationSite Not Available
Research Site
Murmansk, 183047
Russian FederationSite Not Available
Clinical Trial Site
Nizhny Novgorod,
Russian FederationSite Not Available
Clinical Trial Site
Novosibirsk,
Russian FederationSite Not Available
Research Site
Novosibirsk, 630091
Russian FederationSite Not Available
Research Site
Omsk, 644013
Russian FederationSite Not Available
Clinical Trial Site
Petrozavodsk,
Russian FederationSite Not Available
Research Site
Petrozavodsk, 185019
Russian FederationSite Not Available
Clinical Trial Site
Rostov-na-Donu,
Russian FederationSite Not Available
Research Site
Rostov-on-Don, 344022
Russian FederationSite Not Available
Clinical Trial Site
Saint Petersburg,
Russian FederationSite Not Available
Research Site
Saint-Petersburg, 197022
Russian FederationSite Not Available
Clinical Trial Site
Saratov,
Russian FederationSite Not Available
Research Site
Saratov, 410028
Russian FederationSite Not Available
Research Site
St. Petersburg,
Russian FederationSite Not Available
Clinical Trial Site
Ufa,
Russian FederationSite Not Available
Research Site
Ufa, 450005
Russian FederationSite Not Available
Research Site
Belgrade, 11000
SerbiaSite Not Available
Clinical Trial Site
Singapore,
SingaporeSite Not Available
Research Site
Singapore, 119228
SingaporeSite Not Available
Clinical Trial Site
Barcelona,
SpainSite Not Available
Clinical Trial Site
Madrid,
SpainSite Not Available
Research Site
Madrid, 28040
SpainSite Not Available
Clinical Trial Site
Majadahonda,
SpainSite Not Available
Research Site
Majadahonda, 28220
SpainSite Not Available
Clinical Trial Site
Uppsala,
SwedenSite Not Available
Research Site
Uppsala, 75185
SwedenSite Not Available
Clinical Trial Site
Chang-hua,
TaiwanSite Not Available
Research Site
Changhua, 50006
TaiwanSite Not Available
Clinical Trial Site
Hualien City,
TaiwanSite Not Available
Research Site
Hualien City, 97002
TaiwanSite Not Available
Clinical Trial Site
Kaohsiung,
TaiwanSite Not Available
Clinical Trial Site
Taichung,
TaiwanSite Not Available
Research Site
Taichung, 404
TaiwanSite Not Available
Clinical Trial Site
Tainan,
TaiwanSite Not Available
Research Site
Tainan, 70403
TaiwanSite Not Available
Clinical Trial Site
Taipei,
TaiwanSite Not Available
Research Site
Taipei, 100
TaiwanSite Not Available
Clinical Trial Site
Bangkok,
ThailandSite Not Available
Research Site
Bangkok, 10330
ThailandSite Not Available
Clinical Trial Site
Hat Yai,
ThailandSite Not Available
Clinical Trial Site
Pathum Wan,
ThailandSite Not Available
Clinical Trial Site
Songkhla,
ThailandSite Not Available
Research Site
Songkhla, 90110
ThailandSite Not Available
Research Site
Eskisehir, 26040
TurkeySite Not Available
Clinical Trial Site
Eskişehir,
TurkeySite Not Available
Research Site
Airdrie, ML6 0JS
United KingdomSite Not Available
Clinical Trial Site
Leeds,
United KingdomSite Not Available
Research Site
Leeds,
United KingdomSite Not Available
Clinical Trial Site
London,
United KingdomSite Not Available
Research Site
London, SE5 9NU
United KingdomSite Not Available
Clinical Trial Site
Los Angeles, California 90048
United StatesSite Not Available
Research Site
Los Angeles, California 90033
United StatesSite Not Available
Clinical Trial Site
Whittier, California
United StatesSite Not Available
Research Site
Whittier, California 90603
United StatesSite Not Available
Clinical Trial Site
Fort Worth, Texas 76104
United StatesSite Not Available
Research Site
Fort Worth, Texas 76104
United StatesSite Not Available

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