Thrombotic MicroangiopathyNCT02355782
OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy
A study testing OMS721 in people with Thrombotic Microangiopathy, run by Michal Nowicki.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombotic Microangiopathy
- What is being tested?
- OMS721
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hypersensitivity to OMS721 or any excipients.
- Have a serious medical condition that increases the risk of OMS721 treatment to the patient.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thrombotic Microangiopathy
- Being tested
- OMS721
- Keywords
- TMA, aHUS, TTP, stem cell transplant-associated TMA
- Medical subject headings
- Thrombotic Microangiopathies, Atypical Hemolytic Uremic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMS721Biological
Human IgG4 MASP-2 Monoclonal Antibody
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic MicroangiopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Michal Nowicki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michal Nowicki, Medical University of Lodz
- Investigators
- Michal Nowicki, MD, PhD, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355782
- Sponsor's protocol ID
- TMA-100
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 15 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use
- ClinicalTrials.gov ID
- NCT02355782
- Acronym / sponsor ID
- TMA-100
- Conditions
- Thrombotic Microangiopathy
- Keywords
- TMA, aHUS, TTP, stem cell transplant-associated TMA
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Michal NowickiUniversity, hospital or other
- First posted
- 4 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Hypersensitivity to OMS721 or any excipients.
- Have a serious medical condition that increases the risk of OMS721 treatment to the patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMS721Human IgG4 MASP-2 Monoclonal Antibody | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michal Nowicki, MD, PhD principal investigator
Medical University of Lodz
Questions about this trial
What is this clinical trial studying?
A study testing OMS721 in people with Thrombotic Microangiopathy, run by Michal Nowicki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Nowicki, MD, PhD (+48 (42) 201 4400, nefro@wp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.