Acute Porphyria Biomarkers for Disease Activity
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|ClinicalTrials.gov Identifier: NCT02935400|
Recruitment Status : Enrolling by invitation
First Posted : October 17, 2016
Last Update Posted : July 25, 2018
|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|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
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|