OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
Primary Purpose
Thrombotic Microangiopathy
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
OMS721
Sponsored by
About this trial
This is an expanded access trial for Thrombotic Microangiopathy focused on measuring TMA, aHUS, TTP, stem cell transplant-associated TMA
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Hypersensitivity to OMS721 or any excipients.
- Have a serious medical condition that increases the risk of OMS721 treatment to the patient.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02355782
Brief Title
OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
Official Title
Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michal Nowicki
4. Oversight
5. Study Description
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.
Detailed Description
The study is open-label, expanded access study to provide continued OMS721 treatment for compassionate use to patients who have participated in clinical trial OMS721-TMA-001. Patients will be eligible if markers of disease activity, such as platelet count, LDH, and haptoglobin, were observed to improve during the study or if the patients disease activity remained stable, but they could be treated with a higher dose that may be beneficial. Safety measures of adverse events and laboratory measures will be monitored. Markers of disease activity, pharmacokinetics and ex vivo pharmacodynamics will also be monitored.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombotic Microangiopathy
Keywords
TMA, aHUS, TTP, stem cell transplant-associated TMA
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
OMS721
Intervention Description
Human IgG4 MASP-2 Monoclonal Antibody
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Hypersensitivity to OMS721 or any excipients.
Have a serious medical condition that increases the risk of OMS721 treatment to the patient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Nowicki, MD, PhD
Phone
+48 (42) 201 4400
Email
nefro@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Nowicki, MD, PhD
Organizational Affiliation
Medical University of Lodz
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
We'll reach out to this number within 24 hrs