- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01797276
Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access (CLA)
August 7, 2017 updated by: University of Florida
Expanded access to DCA as continued treatment for congenital lactic acidosis.
Study Overview
Status
No longer available
Conditions
Intervention / Treatment
Detailed Description
Subjects who participated in a Phase 3 Randomized Controlled Trial of DCA for treatment of Congenital Lactic Acidosis (CLA) are eligible to continue treatment with investigational medication DCA at the same dose of 25mg/kg/day for expanded access.
Study participants must travel to the study site for bi-annual evaluation by the study investigator.
Bi-annual evaluation will include an interim medical history review, physical exam, blood collection for DCA trough level, and urine pregnancy testing (if indicated).
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
- Treatment IND/Protocol
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610-0226
- University of Florida Box 100226
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Diagnosis of congenital lactic acidosis
- Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis Exclusion Criteria:
- Intolerance to DCA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
February 15, 2013
First Submitted That Met QC Criteria
February 20, 2013
First Posted (Estimate)
February 22, 2013
Study Record Updates
Last Update Posted (Actual)
August 8, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#420-2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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