EXPLORE: A Natural History Study of Acute Hepatic Porphyria (AHP)

NCT ID: NCT02240784

Last Updated: 2021-05-17

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

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2021-04-26

Brief Summary

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The purpose of this study is to characterize the natural history and clinical management of Acute Hepatic Porphyria (AHP) patients with recurring attacks.

Detailed Description

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Conditions

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Acute Hepatic Porphyria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute Hepatic Porphyria

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Males and females aged \>/= 12 years
* Diagnosis of AHP \[acute intermittent porphyria (AIP), variegate porphyria (VP), hereditary coproporphyria (HCP) and aminolevulinic acid dehydratase (ALAD) deficient porphyria (ADP)\]
* Porphyria attacks in the past 12 months or receiving treatment to prevent attacks
* Willing to provide written informed consent, medical records, and to comply with study requirements

Exclusion Criteria

• Current participation in a clinical trial of an investigational product
Minimum Eligible Age

12 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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Medical Director

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

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Clinical Trial Site

San Francisco, California, United States

Site Status

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Miami, Florida, United States

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Ann Arbor, Michigan, United States

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New York, New York, United States

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Winston-Salem, North Carolina, United States

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Philadelphia, Pennsylvania, United States

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Galveston, Texas, United States

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Salt Lake City, Utah, United States

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Camperdown, New South Wales, Australia

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Leuven, , Belgium

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Sofia, , Bulgaria

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Prague, , Czechia

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Helsinki, , Finland

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Paris, , France

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Chemnitz, , Germany

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Petah Tikva, , Israel

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Milan, , Italy

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Modena, , Italy

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Mexico City, , Mexico

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Rotterdam, , Netherlands

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Bergen, , Norway

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Warsaw, , Poland

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Cape Town, , South Africa

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Seoul, , South Korea

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Barcelona, , Spain

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Murcia, , Spain

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Zurich, , Switzerland

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Taipei, , Taiwan

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Cardiff, Wales, United Kingdom

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London, , United Kingdom

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Countries

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United States Australia Belgium Bulgaria Czechia Finland France Germany Israel Italy Mexico Netherlands Norway Poland South Africa South Korea Spain Switzerland Taiwan United Kingdom

Other Identifiers

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ALN-AS1-NT-001

Identifier Type: -

Identifier Source: org_study_id

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