Myelodysplastic Syndrome Clinical Trial
ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
The study consisted of a 4-week screening period and a 26-week randomized treatment period (Primary Evaluation Period). After completion of the 26-week Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive ravulizumab for up to 5 years.
This study is ongoing. The data presented is for the Primary Evaluation Period. The results for the Extension Period will be reported after study completion.
Criteria For Patient Cohort Originally Enrolled in ALXN1210-PNH-301 Study:
Male or female ≥18 years of age.
PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.
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 gramdeciliter), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; packed red blood cells (pRBC) transfusion due to PNH.
Lactate dehydrogenase (LDH) level ≥1.5 times the upper limit of normal at screening.
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
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.
Willing and able to give written informed consent and comply with study visit schedule.
Treatment with a complement inhibitor at any time.
History of bone marrow transplantation.
Body weight <40 kg.
Females who are pregnant, breastfeeding, or who have a positive pregnancy test at screening or Day 1.
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.
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
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:
All participants regardless of age, who are currently receiving ALXN1210 IV in an ongoing ALXN1210 study in patients with PNH
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
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 30 Locations for this study
Los Angeles California, 90033, United States
Los Angeles California, 90048, United States
Fort Worth Texas, 76104, United States
Buenos Aires , C1015, Argentina
Buenos Aires , C1425, Argentina
Córdoba , , Argentina
Perth , , Australia
Linz , , Austria
Vienna , , Austria
Hasselt , , Belgium
Leuven , , Belgium
Belém , , Brazil
Rio de Janeiro , , Brazil
Salvador , , Brazil
São Paulo , 05403, Brazil
São Paulo , 08270, Brazil
Edmonton , , Canada
Toronto , , Canada
Plzen , , Czechia
Praha , , Czechia
Tallinn , , Estonia
Poitiers Vienne, , France
Limoges , , France
Montpellier , , France
Paris , , France
Pierre-Bénite , , France
Rennes , , France
Essen , , Germany
Ulm , , Germany
Ascoli Piceno , , Italy
Firenze , , Italy
Milano , , Italy
Napoli , , Italy
Vicenza , , Italy
Bunkyō-Ku , 113-8, Japan
Bunkyō-Ku , , Japan
Fukuoka , , Japan
Fukushima , , Japan
Hamamatsu-shi , , Japan
Kanazawa-shi , , Japan
Koshigaya-shi , , Japan
Kumamoto , , Japan
Nishinomiya-shi , , Japan
Ogaki-shi , , Japan
Okayama-city , , Japan
Okayama-shi , , Japan
Osakasayama-shi , , Japan
Sapporo , , Japan
Shimotsuke-shi , , Japan
Shinagawa-Ku , , Japan
Shinjuku-Ku , 160-0, Japan
Shinjuku-Ku , 160-8, Japan
Suita-shi , , Japan
Tokorozawa-shi , , Japan
Toyoake-shi , , Japan
Tsukuba , , Japan
Wakayama-shi , , Japan
Yokohama-City , 227-8, Japan
Yokohama-City , 236-0, Japan
Anyang-si , , Korea, Republic of
Busan , , Korea, Republic of
Daegu , , Korea, Republic of
Incheon , , Korea, Republic of
Jeonju , , Korea, Republic of
Jinju-si , , Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 04401, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 07985, Korea, Republic of
Seoul , 08308, Korea, Republic of
Suwon-si , 16247, Korea, Republic of
Suwon-si , 16499, Korea, Republic of
Ulsan , , Korea, Republic of
Kota Bharu Kelantan, , Malaysia
Miri Sarawak, , Malaysia
Sibu Sarawak, , Malaysia
Ampang , , Malaysia
Johor Bahru , , Malaysia
Kota Bahru , 16150, Malaysia
Kota Bharu , 15586, Malaysia
Kota Kinabalu , , Malaysia
Kubang Kerian , , Malaysia
Kuching , , Malaysia
Pulau Pinang , , Malaysia
Monterrey , , Mexico
Gdańsk , , Poland
Warsaw , , Poland
Arkhangel'sk , , Russian Federation
Barnaul , , Russian Federation
Bryansk , , Russian Federation
Irkutsk , , Russian Federation
Kaluga , , Russian Federation
Kirov , , Russian Federation
Krasnodar , 35000, Russian Federation
Krasnoyarsk , 66000, Russian Federation
Krasnoyarsk , 66002, Russian Federation
Moscow , 12516, Russian Federation
Moscow , 12528, Russian Federation
Murmansk , , Russian Federation
Nizhny Novgorod , , Russian Federation
Novosibirsk , , Russian Federation
Petrozavodsk , , Russian Federation
Rostov-na-Donu , , Russian Federation
Saint Petersburg , , Russian Federation
Saratov , , Russian Federation
Ufa , , Russian Federation
Singapore , , Singapore
Barcelona , , Spain
Madrid , , Spain
Majadahonda , , Spain
Uppsala , , Sweden
Chang-hua , , Taiwan
Hualien City , , Taiwan
Kaohsiung , , Taiwan
Taichung , , Taiwan
Tainan , , Taiwan
Taipei , , Taiwan
Bangkok , , Thailand
Hat Yai , , Thailand
Pathum Wan , , Thailand
Eskişehir , , Turkey
Leeds , , United Kingdom
London , , United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.