Prevalence of Acute Hepatic Porphyria

Brief Title

Prevalence of Acute Hepatic Porphyria

Official Title

Prevalence of Acute Hepatic Porphyria in Population With Suggestive Clinical Picture

Brief Summary

      To determine the proportion of patients suffering from acute hepatic porphyria (AHP) from
      different hospital departments and referred to an internist referent for a suggestive
      clinical picture with a first negative etiological assessment.
    

Detailed Description

      In this context, this study aims to assess the prevalence of PHA in a population of patients
      with a suggestive clinical picture. A better knowledge of the pathology will make it possible
      to better guide patients and prevent them from diagnostic wandering fraught with physical and
      psychological consequences.

      This is an observational, ambispective, transversal, multicenter study carried out in France.
      The goal is to recruit a cohort that will reflect current practice. 500 patients will be
      recruted.
    


Study Type

Observational


Primary Outcome

Binary criterion corresponding to the diagnosis of acute hepatic porphyria (acute hepatic porphyria + / acute hepatic porphyria -) via physiological parameter.


Condition

Acute Hepatic Porphyria

Intervention

Dosage of Delta-aminolevulinic acid and Porphobilinogen


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

500

Start Date

June 2021

Completion Date

April 2022

Primary Completion Date

April 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Man or woman aged 18 to 60;

          -  Presenting severe abdominal pain, afebrile and diffuse over several days, evolving for
             less than 5 years;

          -  With at least one of the following symptoms:

               -  Peripheral neurological symptoms: decreased driving force and pain in the limbs
                  (roots of the thighs), etc. ;

               -  Central neurological symptoms: psychiatric (depression, anxiety, insomnia),
                  disturbances of consciousness, etc. ;

               -  Autonomous neurological symptoms: tachycardia, nausea, vomiting, constipation,
                  etc.

          -  With a first negative etiological assessment requested by an emergency physician,
             gastroenterologist, gynecologist, neurologist, internist or another specialty, or with
             a diagnosis of acute hepatic porphyria less than 6 months;

          -  Patient able to understand the information related to the study and having indicated
             his non-objection to the collection of data concerning him;

        Exclusion Criteria:

          -  Patient with a diagnosis of acute hepatic porphyria for more than 6 months;

          -  Patient unfit to participate in the study, due to cognitive or linguistic
             difficulties;

          -  Protected patient (under legal protection, or deprived of liberty by judicial or
             administrative decision).
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, 01 42 17 80 27, [email protected]



Administrative Informations


NCT ID

NCT04923516

Organization ID

2021-A00566-35


Responsible Party

Sponsor

Study Sponsor

Association pour la Recherche en Medecine Interne


Study Sponsor

, , 


Verification Date

June 2021