Iron Therapy in Erythropoietic Protoporphyria | NCT05572125

Studies
Iron Therapy in Erythropoietic Protoporphyria

NCT05572125

Sponsor

Bispebjerg Hospital

Status

Completed

Last Update Posted

Feb 23, 2023Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Erythropoietic Protoporphyria
Iron-deficiency

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2022Actual

Primary Completion Date

Feb 14, 2023Actual

Completion Date

Feb 14, 2023Actual

First Submitted Date

Oct 5, 2022

First Submission Date that Met QC Criteria

Oct 5, 2022

First Posted Date

Oct 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2023

Last Update Posted Date

Feb 23, 2023Actual

Name	Class
Alfred Benzon Foundation	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Giving oral iron to patients with erythropoietic protoporphyria (EPP) who is iron deficient is thought to be beneficial. This is, however, not well documented. The purpose of this study is to investigate the effect and safety of oral iron in patients with EPP who is taking iron tablets due to iron deficiency.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in erythrocyte protoporphyrin concentration		Before treatment and after 6-8 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Change in hemoglobin and iron parameters		Before treatment and after 6-8 weeks of treatment
Adverse event		6-8 weeks of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with EPP
Taking standard dose of iron tablets due to iron deficiency

Exclusion Criteria:

Pregnant
Lactating

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with EPP taking oral iron tablets due to iron deficiency

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen		2400	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D046351	Protoporphyria, Erythropoietic
D018798	Anemia, Iron-Deficiency

Ancestor Terms

ID	Term
D017094	Porphyrias, Hepatic
D008107	Liver Diseases
D004066	Digestive System Diseases
D012873	Skin Diseases, Genetic

Browse Leaves

Not provided

Browse Branches

Not provided