Natural History Study of MNGIE
July 16, 2021 updated by: Entrada Therapeutics, Inc.
Natural History Study of Mitochondrial Neurogastrointestinal Encephalomyopathy
Non-interventional, prospective, multicenter, natural history study of patients with mitochondrial neurogastrointestinal encephalomyopathy (MNGIE)
Study Overview
Status
Suspended
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ankara, Turkey, 06500
- Gazi Üniversitesi Tıp Fakültesi
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Izmir
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Bornova, Izmir, Turkey
- Ege University Medical Faculty; Department of Pediatrics
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Colorado
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Aurora, Colorado, United States, 80045
- Children's Hospital Colorado
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New York
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New York, New York, United States, 10032
- Columbia University
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Texas
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Houston, Texas, United States, 77030
- Baylor St Luke's Medical Center and Texas Children's Hospital at Baylor College of Medicine
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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
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male or female MNGIE patients greater than 5 years of age
Description
Inclusion Criteria:
- Has MNGIE
Exclusion Criteria:
- Substance abuser
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?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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MNGIE Patients
Patients with mitochondrial neurogastrointestinal encephalomyopathy
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Non-interventional natural history study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MNGIE Clinical Course
Time Frame: 5 years
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To evaluate the clinical course of MNGIE patients
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5 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Michio Hirano, MD, Columbia University
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 Major Dates
Study Start (Actual)
August 6, 2020
Primary Completion (Anticipated)
February 1, 2025
Study Completion (Anticipated)
February 1, 2026
Study Registration Dates
First Submitted
January 27, 2020
First Submitted That Met QC Criteria
January 27, 2020
First Posted (Actual)
January 29, 2020
Study Record Updates
Last Update Posted (Actual)
July 22, 2021
Last Update Submitted That Met QC Criteria
July 16, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ET-NHS-901
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.