An observational study in Rare Diseases and Porphyrias, sponsored by Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia. Status unknown at 1 site in Colombia. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia · Observational
porphyria is classified as a rare disease and is produced by defects in the enzymatic activity in the biosynthesis of the heme group that leads to the over-accumulation and excretion of porphyrin precursors in hepatocytes or erythroid cells, extrahepatic or extramedullary cells, tissue, and end-organ injury. Acute intermittent porphyria is the most common and severe form of hepatic porphyria, with an annual incidence of symptomatic patients of 0.13 per million people. Aim: characterization of cases of acute hepatic porphyria in Colombia. Methods: a descriptive pilot study of patients diagnosed with acute hepatic porphyria's in Colombia. Patients of all age groups with a confirmed diagnosis of acute hepatic porphyria. Patients with concomitant pathologies, as well as pregnant women, will also be included. Patients who refuse to participate in the study will be excluded. Expected results: describe the sociodemographic and clinical characteristics of patients with a diagnosis of acute hepatic porphyria, and encourage patients and/or representatives in the research agenda.
A cross-sectional descriptive observational study is carried out in adult patients diagnosed with HAP in Colombia, the incidence and prevalence were estimated, the clinical, socio-demographic and acute attack characteristics are described, and the health-related quality of life was evaluated with the SF-36 questionnaire.
33 studies on the registry are indexed under Porphyria, Erythropoietic; 1 is open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 14 observational studies indexed under Porphyria, Erythropoietic.
Browse Porphyria, Erythropoietic studies →Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: - Patients of all age groups with a confirmed diagnosis of acute hepatic porphyria with AT LEAST ONE OF THE FOLLOWING CHARACTERISTICS will be included:
Patients with concomitant pathologies, as well as pregnant women, will also be included.
Exclusion criteria:
Inclusion Criteria: - Patients of all age groups with a confirmed diagnosis of acute hepatic porphyria with AT LEAST ONE OF THE FOLLOWING CHARACTERISTICS will be included:
Patients with concomitant pathologies, as well as pregnant women, will also be included.
Exclusion criteria:
Incidence
Total new cases of acute porphyry
Time frame: through study completion, an average of 3 year
Prevalence
Total cases of acute porphyry in Colombia
Time frame: through study completion, an average of 3 year
Life quality
Describe the well-being of patients, seeks to measure the impact that medical interventions have on the level of well-being of the patient, limiting itself to the experience that he has of his illness and its impact on it, evaluated with the The Short Form Health Survey 36 (SF-36 questionnaire: there are 36 questions, the possible score is from 0 to 100, with a higher score indicating a better health-related quality of life.
Time frame: through study completion, an average of 3 year
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia