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

Sponsor
Repligen Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT00060515
Collaborator
(none)
12

Study Details

Study Description

Brief Summary

The objective of the study is to determine the safety and tolerability of RG2133 in patients with Mitochondrial Disease.

Condition or Disease Intervention/Treatment Phase
  • Drug: RG2133 (2',3',5'-tri-O-acetyluridine)
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Primary Purpose:
Treatment
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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Mitochondrial Disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Repligen Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00060515
    Other Study ID Numbers:
    • RG2133-01
    First Posted:
    May 8, 2003
    Last Update Posted:
    Aug 5, 2005
    Last Verified:
    Aug 1, 2005
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 5, 2005