Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

December 21, 2018

Primary Completion Date

June 9, 2021

Study Completion Date

June 9, 2021

Conditions
Immune Thrombocytopenic Purpura (ITP)
Interventions
BIOLOGICAL

Biological: M254

M254 administered as intravenous infusion

DRUG

Placebo

Placebo administered as intravenous infusion

BIOLOGICAL

Intravenous immunoglobulin (IVIg)

IVIg administered as intravenous infusion

Trial Locations (28)

168

Policlinico Universitario Agostino Gemelli, Roma

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

5530

Ucl de Mont-Godinne, Yvoir

7400

Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár

7624

Pecsi Tudomanyegyetem, Pécs

27710

Duke University Medical Center, Durham

29010

Hosp. Regional. Carlos Haya, Málaga

30008

Hosp. Gral. Univ. J.M. Morales Meseguer, Murcia

33014

Lakes Research, Miami Lakes

33701

University of South Florida, St. Petersburg

37007

Hosp Clinico Univ de Salamanca, Salamanca

42123

Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia

44195

Taussig Cancer Insititute Cleveland Clinic, Cleveland

46017

Hosp. Univ. Dr. Peset, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

48100

Azienda Unita Sanitaria Locale di Ravenna, Ravenna

71013

Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia-, San Giovanni Rotondo

90089

University of Southern California, Los Angeles

90603

Oncology Institute of Hope and Innovation, Whittier

9713 GZ

Universitair Medisch Centrum Groningen, Groningen

NZ 9728

PRA Health Sciences, Groningen

41 503

Silesian Healthy Blood Clinic, Chorzów

20-081

Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin

45-061

Szpital Wojewodzki w Opolu, Opole

60-631

Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW w Poznaniu im prof Ludwika Bierkowskiego, Poznan

50 367

Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

08035

Hosp Univ Vall D Hebron, Barcelona

09003

Hosp. Univ. de Burgos, Burgos

Sponsors
All Listed Sponsors
lead

Momenta Pharmaceuticals, Inc.

INDUSTRY

NCT03866577 - Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients | Biotech Hunter | Biotech Hunter