TerminatedNot Applicable

INSIGHT-AHP: A Study to Characterize the Prevalence of Acute Hepatic Porphyria (AHP) in Patients With Clinical Presentation and History Consistent With AHP

Stopped: Sponsor elected not to continue with study

United States212 participantsStarted 2018-05-29

Plain-language summary

This study will use specific diagnostic tests on a group of patients who are experiencing symptoms typical of acute hepatic porphyria (AHP) to determine how many have the condition, and to potentially help improve the diagnostic process for patients in the future.

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥ 16 years of age * Recurrent and severe episodes of abdominal pain that last for at least 24 hours * At least 1 episode of severe abdominal pain that required an urgent healthcare visit in the past 12 months * Other symptoms related to AHP that your doctor will discuss with you * Willing and able to comply with protocol required assessments and provide written informed consent Exclusion Criteria: * Known diagnosis of AHP * Alternative explanation for abdominal pain with clinical response to treatment specific for alternative diagnosis

What they're measuring

Proportion of participants with current or past clinically symptomatic AHP with urinary aminolevulinic acid (ALA) or porphobilinogen (PBG) values above the upper limit of normal (ULN)

Timeframe: 12 months

Trial details

NCT IDNCT03547297

SponsorAlnylam Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-01-15

View on ClinicalTrials.gov More Acute Hepatic Porphyria trials