NCT03460301

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
233

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2020

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

5.4 years

First QC Date

March 4, 2018

Last Update Submit

January 24, 2025

Conditions

PNH

Outcome Measures

Primary Outcomes (1)

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

    5 years

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2018

First Posted

March 9, 2018

Study Start

March 24, 2015

Primary Completion

August 12, 2020

Study Completion

August 12, 2020

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share