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Post Study Continuation of C7 for G1D

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ClinicalTrials.gov Identifier: NCT02018302
Expanded Access Status : Available
First Posted : December 23, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
Juan Pascual, University of Texas Southwestern Medical Center

Brief Summary:
This protocol provides ongoing access to triheptanoin for patients who did complete an initial pilot protocol, and provides the opportunity to collect long-term safety data from patients treated with triheptanoin.

Condition or disease Intervention/treatment
Glut1 Deficiency Syndrome Glucose Transporter Type 1 Deficiency Syndrome Drug: Triheptanoin

Detailed Description:
Only patients who completed the initial pilot study were eligible. The study is ongoing with these patients only.

Study Type : Expanded Access
Official Title: Post Study Continuation of C7 for G1D
Study Start Date : January 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018



Intervention Details:
  • Drug: Triheptanoin
    Other Names:
    • C7 oil
    • Heptanoate
    • heptanoic acid

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Ages Eligible for Study:   1 Month to 28 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients enrolled in the pilot trial (UTSW 122010-186)

Exclusion Criteria:

  • Subjects who did not complete the pilot trial (UTSW 122010-186)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018302


Contacts
Contact: Dorothy Kelly, MA rare.diseases@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Juan Pascual
Investigators
Principal Investigator: Juan M Pascual, MD, PhD UT Southwestern Medical Center

Additional Information:
Publications:

Responsible Party: Juan Pascual, Associate Professor, Director of the Rare Brain Disorders Program, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02018302     History of Changes
Other Study ID Numbers: UTSW 082013-016
First Posted: December 23, 2013    Key Record Dates
Last Update Posted: December 30, 2013
Last Verified: December 2013

Keywords provided by Juan Pascual, University of Texas Southwestern Medical Center:
G1D
Glut1 Deficiency
Glucose Transporter Type 1 Deficiency
Glucose Transporter Type I Deficiency

Additional relevant MeSH terms:
Syndrome
Carbohydrate Metabolism, Inborn Errors
Disease
Pathologic Processes
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases