CClinicalTrials.gg
CompletedNCT03460301OPENKUpdated Jan 27, 2025

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

An observational study in PNH, sponsored by Handok Inc.. Completed. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-01-27.

Sponsored by Handok Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
233
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Idiopatic AA/MDS/Patients who had PNH clone size \<10%

Inclusion criteria

  • Patients with Commbs' test - negative
  • Any patients meeting any of Idiopathic AA/MDS/Patients who had PNH clone size \<10%

Exclusion criteria

Exclusion Criteria:

04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
233 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Time-course changes in the percentage of PNH-type cells in patients who are positive of PNH-type cells during period

    Time frame: 5 years

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03460301
Lead sponsor
Handok Inc.
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Mar 24, 2015
Primary completion
Aug 12, 2020
Completion
Aug 12, 2020
Last update
Jan 27, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion