RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease - Tabular View

Tracking Information
First Received Date ^ICMJE	May 7, 2003
Last Updated Date	August 4, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00060515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	RG2133 (2',3',5'-Tri-O-Acetyluridine) in Mitochondrial Disease
Official Title ^ICMJE	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
Brief Summary	The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized
Condition ^ICMJE	Mitochondrial Diseases
Intervention ^ICMJE	Drug: RG2133 (2',3',5'-tri-O-acetyluridine)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	12
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Mitochondrial Disease
Gender	Both
Ages	3 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00060515
Responsible Party
Study ID Numbers ^ICMJE	RG2133-01
Study Sponsor ^ICMJE	Repligen Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Repligen Corporation
Verification Date	August 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP