Trial record 5 of 242 for:    "Expanded Access" [STUDY-TYPES]

Post Study Continuation of C7 for G1D

Expanded access is currently available for this treatment.
Verified December 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Juan Pascual, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02018302
First received: December 11, 2013
Last updated: December 26, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Glut1 Deficiency Syndrome
Glucose Transporter Type 1 Deficiency Syndrome
Drug: Triheptanoin
Phase 1

Study Type: Expanded Access     What is Expanded Access?
Official Title: Post Study Continuation of C7 for G1D

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Study Start Date: January 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Triheptanoin
    Other Names:
    • C7 oil
    • Heptanoate
    • heptanoic acid
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   1 Month to 28 Years
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: December 11, 2013
Last Updated: December 26, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014