Back to resultsRG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease
Primary Purpose
Mitochondrial Diseases
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
RG2133 (2',3',5'-tri-O-acetyluridine)
Sponsored by
About this trial
This is an interventional treatment trial for Mitochondrial Diseases
Eligibility Criteria
Mitochondrial Disease
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00060515
Brief Title
RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease
Official Title
An Open-Label Dose-Escalation Phase I Study to Asses the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RG2133 (2',3',5'-Tri-O-Acetyluridine) in the Treatment of Inherited Mitochondrial Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
August 2005
Overall Recruitment Status
Terminated
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Repligen Corporation
4. Oversight
5. Study Description
Brief Summary
The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Allocation
Non-Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RG2133 (2',3',5'-tri-O-acetyluridine)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Mitochondrial Disease
12. IPD Sharing Statement
Learn more about this trial
RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease
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