PNH Clinical Trial - Observational of PNH Type Cells in NCT03460301

Updated 06/21/2024

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number	NCT03460301
Other study ID #	OPENK
Secondary ID
Status	Active, not recruiting
Phase	N/A
First received	March 4, 2018
Last updated	March 4, 2018
Start date	March 2015
Est. completion date	July 2020

Study information
Verified date	March 2018
Source	Handok Pharmaceuticals Co., Ltd.
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

Patients who are positive of PNH-type cells are followed up for the percentage of PNH-type cells regularly for examining how it change.

Recruitment information / eligibility
Status	Active, not recruiting
Enrollment	236
Est. completion date	July 2020
Est. primary completion date	July 2020
Accepts healthy volunteers
Gender	All
Age group	19 Years and older
Eligibility	Inclusion Criteria: - Patients with Commbs' test - negative - Any patients meeting any of Idiopathic AA/MDS/Patients who had PNH clone size <10% Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country	Name	City	State
n/a

Sponsors *(1)*
Lead Sponsor	Collaborator
Handok Pharmaceuticals Co., Ltd.

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Time-course changes in the percentage of PNH-type cells in patients who are positive of PNH-type cells during period		5 years

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