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

NCT ID: NCT03547297

Last Updated: 2019-01-25

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

TERMINATED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-29

Study Completion Date

2019-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Hepatic Porphyria Hepatic Porphyrias Acute Intermittent Porphyria (AIP) Hereditary Coproporphyria (HCP) Variegate Porphyria (VP) ALA Dehydratase Deficient Porphyria (ADP) Porphyria Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Quinn Dinh, MD

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Clinical Trial Site

Pasadena, California, United States

Site Status

Clinical Trial Site

Jacksonville, Florida, United States

Site Status

Clinical Trial Site

Margate, Florida, United States

Site Status

Clinical Trial Site

Ames, Iowa, United States

Site Status

Clinical Trial Site

Las Vegas, Nevada, United States

Site Status

Clinical Trial Site

Manhasset, New York, United States

Site Status

Clinical Trial Site

Winston-Salem, North Carolina, United States

Site Status

Clinical Trial Site

Pittsburgh, Pennsylvania, United States

Site Status

Clinical Trial Site

Pottsville, Pennsylvania, United States

Site Status

Clinical Trial Site

Knoxville, Tennessee, United States

Site Status

Clinical Trial Site

Houston, Texas, United States

Site Status

Clinical Trial Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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ALN-AS1-NT-002

Identifier Type: -

Identifier Source: org_study_id

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