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| Sponsor: | Repligen Corporation |
|---|---|
| Information provided by: | Repligen Corporation |
| ClinicalTrials.gov Identifier: | NCT00060515 |
Purpose
The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Mitochondrial Diseases |
Drug: RG2133 (2',3',5'-tri-O-acetyluridine) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| 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 |
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Mitochondrial Disease
Contacts and Locations
More Information
| Study ID Numbers: | RG2133-01 |
| Study First Received: | May 7, 2003 |
| Last Updated: | August 4, 2005 |
| ClinicalTrials.gov Identifier: | NCT00060515 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Metabolic Diseases Mitochondrial Diseases |