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

March 4, 2018 updated by: Handok Inc.

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Handok Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

March 4, 2018

First Submitted That Met QC Criteria

March 4, 2018

First Posted (Actual)

March 9, 2018

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 4, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPENK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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