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

This study has been terminated.

Sponsor:

Information provided by:

Repligen Corporation

ClinicalTrials.gov Identifier:

NCT00060515

First received: May 7, 2003

Last updated: August 4, 2005

Last verified: August 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	May 7, 2003
Last Updated Date	August 4, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00060515 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Primary Purpose: Treatment
Condition ^ICMJE	Mitochondrial Diseases
Intervention ^ICMJE	Drug: RG2133 (2',3',5'-tri-O-acetyluridine)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	12
Completion Date	Not Provided
Primary Completion Date	Not Provided
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	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00060515
Other Study ID Numbers ^ICMJE	RG2133-01
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Repligen Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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