Observational of PNH Type Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic PNH

PNH Clinical Trial

— OPENK  

Official title:

Observational of GPI-anchored Protein-deficient (PNH-Type) Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic Paroxymal Nocturnal Hemoglobinuria (OPENK)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03460301
• Other study ID #: OPENK
• 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
• 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
• 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:

Related Conditions & MeSH terms

• Anemia, Aplastic
• Hemoglobinuria, Paroxysmal
• Pancytopenia
• PNH

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