Colon Cancer Clinical Trial
Long-Chain Fatty Acid Oxidation Disorders In-Clinic Disease Monitoring Program
Summary
The primary objective of this study is to assess the long-term safety, including pregnancy, infant, and lactation outcomes, of patients with LC-FAOD who are enrolled in the DMP.
Full Description
The LC-FAOD DMP is a global observational long-term prospective outcomes study aiming to collect information for up to 10 years from adult and pediatric patients with LC-FAOD, regardless of disease management, including treatment with triheptanoin, and those who have previously participated in triheptanoin clinical trials or Expanded Access Program (EAP).
Patients enrolling in the LC-FAOD DMP will be managed at the discretion of their physicians and may or may not be treated with triheptanoin during the course of the study. Patients will only have access to triheptanoin through authorized commercial use (if approved in their country) or available EAP but not from the LC-FAOD DMP itself.
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of any LC-FAOD sub-type. Diagnosis must be confirmed by results of acylcarnitine profiles, and/or genetic testing results obtained from medical records or equivalent documentation.
Willing and able to comply with all study procedures.
Willing and able to provide consent or, if a minor, provide assent and informed consent by their legally authorized representative.
Female of child-bearing potential who become pregnant during the study will be invited to remain in the study. Pregnant females with LC-FAOD will be informed of the study and invited to enroll.
Pregnant females not affected by LC-FAOD carrying a fetus affected by LC-FAOD with confirmed pre-natal diagnosis of LC-FAOD.
Exclusion Criteria:
Presence of a concurrent disease or condition that would interfere with study participation or affect patient's safety in the opinion of the Investigator.
Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of not completing the study or would affect the interpretation of study results.
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There are 15 Locations for this study
Phoenix Arizona, 85016, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
Tampa Florida, 33606, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Boston Massachusetts, 02215, United States
Minneapolis Minnesota, 55454, United States
New York New York, 10032, United States
Columbus Ohio, 43205, United States
Pittsburgh Pennsylvania, 15224, United States
Salt Lake City Utah, 84108, United States
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 1, Canada
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