Clinical Trial: EXPLORE: A Natural History Study of Acute Hepatic Porphyria (AHP)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational
Official Title: A Natural History Study of Acute Hepatic Porphyria (AHP) Patients With Recurrent Attacks
Brief Summary: The purpose of this study is to characterize the natural history and clinical management of Acute Hepatic Porphyria (AHP) patients with recurring attacks.
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome:
- Medical history of AHP patients [ Time Frame: Baseline to 6-Month Follow-Up Visit ]
- Medication usage of AHP patients [ Time Frame: Baseline to 6-Month Follow-Up Visit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Plasma biomarkers [ Time Frame: 0, 6 months and During Attacks ]
- Porphyria signs and symptoms [ Time Frame: 0, 2, 4, 6 months ]
- Quality of Life [ Time Frame: 0, 6 months ]
- Urine biomarkers [ Time Frame: 0, 6 months and During Attacks ]
- Healthcare Utilization [ Time Frame: 0, 6 months ]
Original Secondary Outcome: Same as current
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: September 11, 2014
Date Started: August 2014
Date Completion: November 2016
Last Updated: December 11, 2015
Last Verified: December 2015