Longitudinal Study of the Porphyrias
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- The American Porphyrias Expert Collaborative
- Study ID
- NCT01561157
- Status
- Recruiting
Conditions
- Acute Porphyrias
- Cutaneous Porphyrias
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Minute - N/A
- Healthy Volunteers
- Not accepted
Study Details
The objective of this protocol is to conduct a longitudinal multidisciplinary investigation of the human porphyrias including the natural history, morbidity, pregnancy outcomes, and mortality in people with these disorders.
Key Dates
- Start date
- Nov 1, 2010
- Status verified
- May 2026
- Primary completion
- Jun 30, 2030
- Completion
- Jun 30, 2030
Study Design
- Enrollment
- 1,500 participants (estimated)
Arms
- Arm: Acute Intermittent Porphyria (AIP)Patients with a documented diagnosis of AIP
- Arm: Hereditary Coproporphyria (HCP)Patients with a documented diagnosis of HCP
- Arm: Variegate Porphyria (VP)Patients with a documented diagnosis of VP
- Arm: Congenital Erythropoietic Porphyria (CEP)Patients with a documented diagnosis of CEP
- Arm: Hepatoerythropoietic Porphyria (HEP)Patients with a documented diagnosis of HEP
- Arm: Porphyria Cutanea Tarda (PCT)Patients with a documented diagnosis of PCT
- Arm: Erythropoietic Protoporphyria (EPP)Patients with a documented diagnosis of EPP
- Arm: X-Linked Protoporphyria (XLP)Patients with a documented diagnosis of XLP
- Arm: Aminolevulinate-Dehydratase Deficiency Porphyria (ALAD, ADP)Patients with a documented diagnosis of ALAD, ADP
- Arm: Homozygous Dominant Acute Hepatic PorphyriaPatients with a documented diagnosis of Homozygous Dominant AHP
Primary Outcome Measure
clinical analysis [ Time Frame: baseline ]
Central Contacts
- Kristen P Wheeden, DrPH301-461-9889
Locations (16)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | Brendan McGuire, MD (PRINCIPAL_INVESTIGATOR) |
| University of California, Los Angeles | Los Angeles | California | 90095 | Simon Beaven, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of California, San Francisco | San Francisco | California | 94143 | Alana Sur Bruce Wang, MD (PRINCIPAL_INVESTIGATOR) |
| University of Miami | Miami | Florida | 33136 | Lourdes Olson Diane Sabogal Cynthia Levy, MD (PRINCIPAL_INVESTIGATOR) |
| University of Illinois at Chicago | Chicago | Illinois | 60637 | Sean Quigley, MD (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Lina Rebeiz Narmene Bensaber Amy Dickey, MD (PRINCIPAL_INVESTIGATOR) |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Diondra Howard Kimberly Dehn Marshall Mazepa, MD (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Manisha Balwani, MD, MS (PRINCIPAL_INVESTIGATOR) |
| Carolinas Medical Center and HealthCare System | Charlotte | North Carolina | 28203 | - |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27106 | Sean Rudnick, MD (PRINCIPAL_INVESTIGATOR) |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Angelika Erwin, MD, PhD Gretchen LaRusch Angelika Erwin, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | Manisha Verma Manish Thapar, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas Medical Branch | Galveston | Texas | 77555 | Karl E. Anderson, MD (PRINCIPAL_INVESTIGATOR) |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Akshata Moghe, MD, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Utah | Salt Lake City | Utah | 84132 | John Phillips, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Washington | Seattle | Washington | 98195 | Eva Gill Sioban Keel, MD (PRINCIPAL_INVESTIGATOR) |