- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02355782
OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
April 14, 2015 updated by: Michal Nowicki
Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use
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.
Study Overview
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.
Study Type
Expanded Access
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
January 28, 2015
First Submitted That Met QC Criteria
January 30, 2015
First Posted (ESTIMATE)
February 4, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
April 15, 2015
Last Update Submitted That Met QC Criteria
April 14, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMA-100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Thrombotic Microangiopathy
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Swedish Orphan BiovitrumApellis Pharmaceuticals, Inc.RecruitingTransplant-Associated Thrombotic MicroangiopathyUnited States, France, Greece, Italy, Spain
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Hospices Civils de LyonRecruitingHematopoietic Stem Cell Transplantation-Associated Thrombotic MicroangiopathyFrance
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Omeros CorporationImpatients N.V. trading as myTomorrowsAvailableHematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
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Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingThrombotic Microangiopathies
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AKARI TherapeuticsRecruitingThrombotic MicroangiopathiesUnited States, United Kingdom, Poland
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The First Affiliated Hospital of Soochow UniversityCompletedHematologic Diseases | Thrombotic MicroangiopathiesChina
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Omeros CorporationCompletedThrombotic MicroangiopathiesUnited States, Belgium, Bulgaria, Hong Kong, Italy, Lithuania, Malaysia, New Zealand, Poland, Singapore, Taiwan, Thailand
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University Hospital, RouenNot yet recruiting
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Jubilee Mission Medical College and Research InstituteRecruitingSNAKEBITE | THROMBOTIC MICROANGIOPATHY | SCHISTOCYTESIndia
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Peking University Third HospitalNot yet recruitingPregnancy-related Thrombotic Microangiopathies
Clinical Trials on OMS721
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Omeros CorporationUnknownThrombotic Microangiopathies | Atypical Hemolytic Uremic SyndromeUnited States
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Omeros CorporationImpatients N.V. trading as myTomorrowsAvailableHematopoietic Stem Cell Transplant Associated Thrombotic Microangiopathy (HSCT-TMA)
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Omeros CorporationCompletedThrombotic MicroangiopathiesUnited States, Belgium, Bulgaria, Hong Kong, Italy, Lithuania, Malaysia, New Zealand, Poland, Singapore, Taiwan, Thailand
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Omeros CorporationUnknownLupus Nephritis | IgAN | C3 Glomerulopathy | MNUnited States, Hong Kong
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Omeros CorporationTerminatedIgA NephropathyUnited States, Argentina, Australia, Belgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, India, Italy, Korea, Republic of, Lithuania, Poland, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom
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QuantumLeap Healthcare CollaborativeM.D. Anderson Cancer Center; University of Colorado, Denver; University of Pennsylvania and other collaboratorsRecruitingCOVID-19United States