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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03682731
Other study ID # Erythropoietic protoporphyria
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date August 1, 2017

Study information

Verified date September 2018
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: Erythropoietic protoporphyria (EPP) is characterized by development of painful skin symptoms upon exposure to visible light dye to accumulation of the photoactive substance protoporphyrin IX (PpIX) in the skin.This study aimed to quantify the actual light exposure of patients with EPP during everyday life. The investigators further aimed to establish the associations between symptoms and light exposure, use of protective clothes, and erythrocyte PpIX concentration.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date August 1, 2017
Est. primary completion date August 1, 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Diagnosed with erythropoietic protoporphyria

- Informed consent

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Bispebjerg Hospital Copenhagen
Denmark Bispebjerg Hospital Copenhagen NV

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Actual light exposure Actual light exposure of patients with erythropoietic protoporphyria from April through June 2017
See also
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Recruiting NCT00206869 - Does Exercise and Heat Increase the Lightsensibility in Patients With Erythropoietic Protoporphyria N/A
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Enrolling by invitation NCT05883748 - Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants With EPP Phase 2/Phase 3
Completed NCT01097044 - Phase II Confirmatory Study in Erythropoietic Protoporphyria (EPP) Phase 2