Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03866577
Other study ID # CR108979
Secondary ID 2018-003534-32MO
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date December 21, 2018
Est. completion date June 9, 2021

Study information

Verified date May 2024
Source Momenta Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.


Description:

The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date June 9, 2021
Est. primary completion date June 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Key Criteria for Healthy Volunteers: Subject must be between the ages of 18 and 55 years; healthy as indicated by medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram, and all abnormal findings are assessed as not clinically significant by the Investigator; not pregnant or breastfeeding; and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate. Key Criteria for Immune Thrombocytopenic Purpura (ITP) Patients: Patient must be aged =18 years and diagnosed with ITP at least 3 months prior to screening, stable maintenance therapy for at least 4 weeks prior to the first study visit, not pregnant or breastfeeding, and no other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Biological: M254
M254 administered as intravenous infusion
Drug:
Placebo
Placebo administered as intravenous infusion
Biological:
Intravenous immunoglobulin (IVIg)
IVIg administered as intravenous infusion

Locations

Country Name City State
Belgium Ucl de Mont-Godinne Yvoir
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary Pecsi Tudomanyegyetem Pecs
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola
Italy Azienda Unita Sanitaria Locale di Ravenna Ravenna
Italy Arcispedale Santa Maria Nuova - IRCCS Reggio Emilia
Italy Policlinico Universitario Agostino Gemelli Roma
Italy Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia- San Giovanni Rotondo
Netherlands PRA Health Sciences Groningen
Netherlands Universitair Medisch Centrum Groningen Groningen
Poland Silesian Healthy Blood Clinic Chorzow
Poland Samodzielny Publiczny Szpital Kliniczny Nr 1 Lublin
Poland Szpital Wojewodzki w Opolu Opole
Poland Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW w Poznaniu im. prof. Ludwika Bierkowskiego Poznan
Poland Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu Wroclaw
Spain Hosp. Univ. Vall D Hebron Barcelona
Spain Hosp. Univ. de Burgos Burgos
Spain Hosp. Regional. Carlos Haya Malaga
Spain Hosp. Gral. Univ. J.M. Morales Meseguer Murcia
Spain Hosp. Clinico Univ. de Salamanca Salamanca
Spain Hosp. Univ. Dr. Peset Valencia
United States Taussig Cancer Insititute - Cleveland Clinic Cleveland Ohio
United States Duke University Medical Center Durham North Carolina
United States University of Southern California Los Angeles California
United States Lakes Research Miami Lakes Florida
United States University of South Florida Saint Petersburg Florida
United States Oncology Institute of Hope and Innovation Whittier California

Sponsors (1)

Lead Sponsor Collaborator
Momenta Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Hungary,  Italy,  Netherlands,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number and Severity of Adverse Events (AEs) - Part A Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part A Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part A Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in Vital Signs - Part A Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part A Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in Electrocardiograms (ECGs) - Part A Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for Electrocardiograms (ECGs) - Part A Up to approximately Day 29
Primary Number and Severity of AEs - Part B Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part B Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part B Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in Vital Signs - Part B Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part B Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in ECGs - Part B Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part B Up to approximately Day 29
Primary Number and Severity of AEs - Part C Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part C Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part C Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in Vital Signs - Part C Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part C Up to approximately Day 29
Primary Frequency of Clinically Significant Abnormalities in ECGs - Part C Up to approximately Day 29
Primary Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part C Up to approximately Day 29
Primary Measurement of Changes in Platelet Counts After M254 Administration Compared to IVIg - Part C Baseline to approximately Day 29
Primary Number and Severity of AEs - Part D Up to approximately Day 71
Primary Frequency of Clinically Significant Abnormalities in Clinical Safety Laboratory Values - Part D Up to approximately Day 71
Primary Shift From Baseline in Clinically Significant Abnormalities for Clinical Safety Laboratory Values - Part D Up to approximately Day 71
Primary Frequency of Clinically Significant Abnormalities in Vital Signs - Part D Up to approximately Day 71
Primary Shift From Baseline in Clinically Significant Abnormalities for Vital Signs - Part D Up to approximately Day 71
Primary Frequency of Clinically Significant Abnormalities in ECGs - Part D Up to approximately Day 71
Primary Shift From Baseline in Clinically Significant Abnormalities for ECGs - Part D Up to approximately Day 71
Secondary Maximum Plasma Concentration (Cmax) of M254 - Part A, B, and C Day 1 to Day 29
Secondary Time to Maximum Plasma Concentration (Tmax) of M254 - Part A, B, and C Day 1 to Day 29
Secondary Area Under the Concentration-time Curve From Zero to Time of Last Measurable Concentration Area [AUC(0 last)] of M254 - Part A, B, and C Day 1 to Day 29
Secondary Area Under the Concentration-time Curve From Zero to Infinity [AUC(0 8)] of M254 - Part A, B, and C Day 1 to Day 29
Secondary Volume of Distribution (Vd) of M254 - Part A, B, and C Day 1 to Day 29
Secondary Clearance of Drug (CL) M254 - Part A, B, and C Day 1 to Day 29
Secondary Mean Residence Time (MRT) of M254 - Part A, B, and C Day 1 to Day 29
Secondary Apparent Terminal-phase Half-life (t½) of M254 - Part A, B, and C Day 1 to Day 29
Secondary Cmax of M254 - Part D Day 1 to Day 71
Secondary Tmax of M254 - Part D Day 1 to Day 71
Secondary AUC(0 last) of M254 - Part D Day 1 to Day 71
Secondary AUC(0 8) of M254 - Part D Day 1 to Day 71
Secondary Vd of M254 - Part D Day 1 to Day 71
Secondary CL of M254 - Part D Day 1 to Day 71
Secondary MRT of M254 - Part D Day 1 to Day 71
Secondary t½ of M254 - Part D Day 1 to Day 71
Secondary Measurements of Changes in Platelet Counts After M254 Administration - Part D Baseline to approximately Day 71
See also
  Status Clinical Trial Phase
Completed NCT03524612 - A Study to Assess the Ability of Eltrombopag to Induce Sustained Response Off Treatment in Subjects With ITP Phase 2
Completed NCT01713738 - Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Phase 1/Phase 2
Completed NCT00157079 - Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders Phase 3
Recruiting NCT02877212 - Association of FcγRIIIA Polymorphism and THPO Expression With Response to Eltrombopag in Refractory ITP Patients Phase 3
Completed NCT00162006 - Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura Phase 2