A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria

PHASE3CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 7, 2019

Primary Completion Date

September 21, 2021

Study Completion Date

October 21, 2021

Conditions
Paroxysmal Nocturnal Hemoglobinuria
Interventions
DRUG

SB12 (proposed eculizumab biosimilar)

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

DRUG

Soliris (eculizumab)

600 mg IV every week for first 4 weeks and 900 mg for the fifth week, followed by 900 mg every 2 weeks thereafter

Trial Locations (27)

18009

Municipal Institution Cherkasy Regional Oncology Dispensary of Cherkasy Regional Council, Cherkasy

21018

Vinnytsia Regional Clinical Hospital n.a. M.I.Pyrohov, Vinnytsia

122002

Fortis Memorial Research Institute, Gurgaon

Unknown

Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh

Apollo Hospitals International Limited, Chennai

Amrita Institute of Medical Sciences and Research Centre, Kochi

Nil Ratan Sircar Medical College and Hospital, Kolkata

Hospital Ampang, Ampang

Hospital Sultanah Aminah, Johor Bahru

Queen Elizabeth Hospital - Kota Kinabalu, Kota Kinabalu

Hospital Tengku Ampuan Afzan, Kuantan

Hospital Pulau Pinang, Pulau Pinang

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Tlalpan

Colentina Clinical Hospital, Bucharest

Emergency University Hospital, Bucharest

Prof Dr I Chiricuta Institute of Oncology, Cluj-Napoca

Filantropia Municipal Clinical Hospital, Craiova

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

National Cheng Kung University Hospital, Tainan City

National Taiwan University Hospital, Taipei

Tri-Service General Hospital, Taipei

Chang Gung Memorial Hospital, Taoyuan District

Chulalongkorn University, Bangkok

Srinagarind Hospital, Nai Muang

Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv

Poltava Regional Clinical Hospital n.a. M.V. Sklifosovskyi, Poltava

All Listed Sponsors
lead

Samsung Bioepis Co., Ltd.

INDUSTRY

NCT04058158 - A Study to Compare SB12 (Proposed Eculizumab Biosimilar) to Soliris in Subjects With Paroxysmal Nocturnal Haemoglobinuria | Biotech Hunter | Biotech Hunter