Acute Porphyria Biomarkers for Disease Activity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02935400|
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment|
|Acute Intermittent Porphyria Hereditary Coproporphyria Variegate Porphyria||Drug: Hemin|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Acute Porphyrias: Biomarkers for Disease Activity and Response to Treatment|
|Actual Study Start Date :||April 28, 2014|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2023|
Group 1 will have had no symptoms of porphyria in the past year.
Symptomatic and treated with hemin
Group 2 will have a history of symptoms within the past year.
Hemin will be administered under a separate protocol or for clinical treatment, and samples will be collected under this protocol before and after treatment.
Other Name: Panhematin
- Potential biomarkers Biomarkers [ Time Frame: 10 days ]Expression of heme biosynthetic and heat and stress response genes
Biospecimen Retention: Samples Without DNA
- Blood specimens collected in Paxgene tubes for isolation of RNA for expression studies.
- Blood samples for metabolomic studies
- Urine samples for metabolomic studies
- Stool samples for metabolomic studies
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): NCT02935400
|United States, Texas|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|Principal Investigator:||Karl E Anderson||University of Texas|