Myelodysplastic Syndrome Clinical Trial

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

Summary

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).

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Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Criteria For Patient Cohort Originally Enrolled in ALXN1210-PNH-301 Study:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

270

Study ID:

NCT02946463

Recruitment Status:

Active, not recruiting

Sponsor:

Alexion Pharmaceuticals

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There are 30 Locations for this study

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Clinical Trial Site
Los Angeles California, 90033, United States
Clinical Trial Site
Los Angeles California, 90048, United States
Clinical Trial Site
Fort Worth Texas, 76104, United States
Clinical Trial Site
Buenos Aires , C1015, Argentina
Clinical Trial Site
Buenos Aires , C1425, Argentina
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Córdoba , , Argentina
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Perth , , Australia
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Linz , , Austria
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Vienna , , Austria
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Hasselt , , Belgium
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Leuven , , Belgium
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Belém , , Brazil
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Rio de Janeiro , , Brazil
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Salvador , , Brazil
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São Paulo , 05403, Brazil
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São Paulo , 08270, Brazil
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Edmonton , , Canada
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Toronto , , Canada
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Plzen , , Czechia
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Praha , , Czechia
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Tallinn , , Estonia
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Poitiers Vienne, , France
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Limoges , , France
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Montpellier , , France
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Paris , , France
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Pierre-Bénite , , France
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Rennes , , France
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Essen , , Germany
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Ulm , , Germany
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Ascoli Piceno , , Italy
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Firenze , , Italy
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Milano , , Italy
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Napoli , , Italy
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Vicenza , , Italy
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Bunkyō-Ku , 113-8, Japan
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Bunkyō-Ku , , Japan
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Fukuoka , , Japan
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Fukushima , , Japan
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Hamamatsu-shi , , Japan
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Kanazawa-shi , , Japan
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Koshigaya-shi , , Japan
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Kumamoto , , Japan
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Nishinomiya-shi , , Japan
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Ogaki-shi , , Japan
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Okayama-city , , Japan
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Okayama-shi , , Japan
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Osakasayama-shi , , Japan
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Sapporo , , Japan
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Shimotsuke-shi , , Japan
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Shinagawa-Ku , , Japan
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Shinjuku-Ku , 160-0, Japan
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Shinjuku-Ku , 160-8, Japan
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Suita-shi , , Japan
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Tokorozawa-shi , , Japan
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Toyoake-shi , , Japan
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Tsukuba , , Japan
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Wakayama-shi , , Japan
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Yokohama-City , 227-8, Japan
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Yokohama-City , 236-0, Japan
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Anyang-si , , Korea, Republic of
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Busan , , Korea, Republic of
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Daegu , , Korea, Republic of
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Incheon , , Korea, Republic of
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Jeonju , , Korea, Republic of
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Jinju-si , , Korea, Republic of
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Seoul , 02841, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 04401, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Seoul , 07985, Korea, Republic of
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Seoul , 08308, Korea, Republic of
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Suwon-si , 16247, Korea, Republic of
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Suwon-si , 16499, Korea, Republic of
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Ulsan , , Korea, Republic of
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Kota Bharu Kelantan, , Malaysia
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Miri Sarawak, , Malaysia
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Sibu Sarawak, , Malaysia
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Ampang , , Malaysia
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Johor Bahru , , Malaysia
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Kota Bahru , 16150, Malaysia
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Kota Bharu , 15586, Malaysia
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Kota Kinabalu , , Malaysia
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Kubang Kerian , , Malaysia
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Kuching , , Malaysia
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Pulau Pinang , , Malaysia
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Monterrey , , Mexico
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Gdańsk , , Poland
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Warsaw , , Poland
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Arkhangel'sk , , Russian Federation
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Barnaul , , Russian Federation
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Bryansk , , Russian Federation
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Irkutsk , , Russian Federation
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Kaluga , , Russian Federation
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Kirov , , Russian Federation
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Krasnodar , 35000, Russian Federation
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Krasnoyarsk , 66000, Russian Federation
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Krasnoyarsk , 66002, Russian Federation
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Moscow , 12516, Russian Federation
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Moscow , 12528, Russian Federation
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Murmansk , , Russian Federation
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Nizhny Novgorod , , Russian Federation
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Novosibirsk , , Russian Federation
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Petrozavodsk , , Russian Federation
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Rostov-na-Donu , , Russian Federation
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Saint Petersburg , , Russian Federation
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Saratov , , Russian Federation
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Ufa , , Russian Federation
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Singapore , , Singapore
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Barcelona , , Spain
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Madrid , , Spain
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Majadahonda , , Spain
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Uppsala , , Sweden
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Chang-hua , , Taiwan
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Hualien City , , Taiwan
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Kaohsiung , , Taiwan
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Taichung , , Taiwan
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Tainan , , Taiwan
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Taipei , , Taiwan
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Bangkok , , Thailand
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Hat Yai , , Thailand
Clinical Trial Site
Pathum Wan , , Thailand
Clinical Trial Site
Eskişehir , , Turkey
Clinical Trial Site
Leeds , , United Kingdom
Clinical Trial Site
London , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 3

Estimated Enrollment:

270

Study ID:

NCT02946463

Recruitment Status:

Active, not recruiting

Sponsor:


Alexion Pharmaceuticals

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