OMS721 Compassionate Use in Patients With Thrombotic Microangiopathy

Thrombotic Microangiopathy Clinical Trial

Official title:

Provision of OMS721 to Patients With Thrombotic Microangiopathy Under Compassionate Use

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT02355782
• Other study ID #: TMA-100
• Status: Available
• Phase: N/A
• First received: January 28, 2015
• Last updated: April 14, 2015

Study information

• Verified date: January 2015
• Source: Medical Universtity of Lodz
• Contact: Michal Nowicki, MD, PhD
• Phone: +48 (42) 201 4400
• Email: nefro[@]wp.pl
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Expanded Access

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Thrombotic Microangiopathies
• Thrombotic Microangiopathy
• Vascular Diseases

Intervention

Biological:
• OMS721
Human IgG4 MASP-2 Monoclonal Antibody

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Michal Nowicki