Recruiting

Observational Study

Sponsor:

International PNH Interest Group

Code:

NCT06524726

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The aim of this International PNH Interest Group (IPIG) registry is to develop an international database to prospectively collect data on patients with PNH covering clinical outcomes, patient reported outcomes (PROs), and health-resource utilization (HRU) on all enrolled patients, as well as long term safety data.

Conditions

Paroxysmal Nocturnal Hemoglobinuria

Study ID

NCT06524726

Start date

May 10, 2024

Status verified date

Jul, 2024

Completion date

May 10, 2029

Anticipated

Primary completion date

May 10, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients with PNH confirmed by flow cytometry.
  • Patient and/or parent/legally authorized representative provide written informed consent/assent to participate in the registry in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations.

Exclusion Criteria:

  • Participating in an interventional PNH clinical trial. Note: A patient included in the registry, who enrolls in an interventional PNH clinical trial during the course of the registry, will be kept in the registry but data collection will be paused in the registry during their involvement in the clinical trial/extension study. Data collection in the registry will continue after patient involvement in the clinical trial/extension study has ended or trial protocol mandated data collection ceases.

Study Design

Enrollment

2000 participants

Anticipated

Interventions and Outcome Measures

Arms

PNH patients not receiving anti-complement treatment

PNH patients of any age who are not receiving any anti-complement treatment

PNH patients receiving anti-complement treatment

PNH patients of any age who are receiving an approved anti-complement treatment

Primary outcome measure

  • Increase knowledge of PNH and describe the PNH patient population [ Time Frame: 5-10 years ]

Central Contacts and Locations

Central contacts

IPIG Registry Coordinator

Please emailregistry@pnhinterestgroup.org

Locations

International PNH Interest Group

Recruiting

Altamonte Springs, Florida, United States, 32714

Contacts

IPIG Registry Coordinator

registry@pnhinterestgroup.org

More Information

Sponsor

International PNH Interest Group

Last update posted

Jul 29, 2024

Last verified

Jul, 2024

Keywords

  • PNH
  • Registry
  • Patient Registry
  • Paroxysmal Nocturnal Hemoglobinuria
  • Anemia, Hemolytic
  • Anemia
  • Hematologic Diseases
  • Myelodysplastic Syndromes
  • Bone Marrow Diseases
  • Hemoglobinuria
  • Hemoglobinuria, Paroxysmal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by International PNH Interest Group on 2024-07-29.