NCT02355782

Brief Summary

The purpose of this compassionate use study, for two patients with thrombotic microangiopathy, is to provide expanded access to patients who have participated in the clinical trial OMS721-TMA-001 and in whom improvement in their disease markers was observed while on treatment or to patients who could otherwise benefit from the treatment. This is a treatment protocol; not a research protocol.Therefore, only patients in study OMS721-TMA-001 deemed eligible by the investigator may participate.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
Last Updated

April 15, 2015

Status Verified

January 1, 2015

First QC Date

January 28, 2015

Last Update Submit

April 14, 2015

Conditions

Thrombotic Microangiopathy

Keywords

TMA, aHUS, TTP, stem cell transplant-associated TMA

Interventions

OMS721BIOLOGICAL

Human IgG4 MASP-2 Monoclonal Antibody

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of thrombotic microangiopathy related to aHUS, TTP or stem cell transplant.
  • Have completed treatment in clinical trial OMS721-TMA-001.
  • Investigator determined that continued treatment with OMS721 could be beneficial.
  • Aged 18 years or older.

You may not qualify if:

  • Hypersensitivity to OMS721 or any excipients.
  • Have a serious medical condition that increases the risk of OMS721 treatment to the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Thrombotic MicroangiopathiesAtypical Hemolytic Uremic Syndrome

Interventions

narsoplimab

Condition Hierarchy (Ancestors)

ThrombocytopeniaBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaHemolytic-Uremic SyndromeUremiaKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAnemia, HemolyticAnemia

Study Officials

  • Michal Nowicki, MD, PhD

    Medical University of Lodz

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Nowicki, MD, PhD

CONTACT

+48 (42) 201 4400nefro@wp.pl

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 4, 2015

Last Updated

April 15, 2015

Record last verified: 2015-01