Identification of Acute Intermittent Porphyria Modifying Genes

NCT ID: NCT05502133

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-23

Study Completion Date

2026-06-30

Brief Summary

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This study proposes to identify the predisposing/protective modifying genes that underlie the acute attacks in symptomatic patients with Acute Intermittent Porphyria (AIP), an autosomal dominant inborn error of heme biosynthesis.

Detailed Description

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Conditions

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Acute Intermittent Porphyria (AIP)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Intermittent Porphyria (AIP)

Symptomatic patients with Acute Intermittent Porphyria (AIP)

A member of an AIP family who possesses an AIP pathogenic mutation and is/has been symptomatic (experienced acute attacks). Parents with no known HMBS mutations or heterozygote with familial mutation or a first, second or third degree relative of the above.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Willing and able to give informed consent
* 12 years of age or older
* Willingness to provide blood/saliva and urine samples, and clinical information
* A member of an AIP family, defined as (must meet one of the following):

1. proband: possesses an AIP pathogenic mutation and is/has been symptomatic (experienced acute attacks in the opinion of the investigator)
2. Parents (no known HMBS mutations or heterozygote with familial mutation)
3. First, second, or third degree relative of (a) or (b)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Robert Desnick

Dean for Genetics and Genomic Medicine Emeritus, Professor and Chair Emeritus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert J Desnick, Ph.D, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chloe Cheung

Role: CONTACT

646-369-2045

Facility Contacts

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Chloe Cheung

Role: primary

646-369-2045

Other Identifiers

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GCO 18-1800

Identifier Type: -

Identifier Source: org_study_id

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