Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06745622

Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-12-20

47

Participants Needed

1

Research Sites

125 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.

CONDITIONS

Official Title

Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with PNH who have previously received and completed HSK39297 treatment and are judged by researchers to benefit from continued treatment
  • Understand the study procedures and voluntarily agree to participate
Not Eligible

You will not qualify if you...

  • Hereditary or acquired complement deficiency
  • Active primary or secondary immunodeficiency
  • History of splenectomy, bone marrow/hematopoietic stem cell or solid organ transplants
  • History of recurrent invasive infections from encapsulated organisms or Mycobacterium tuberculosis
  • History of serious comorbidities unsuitable for study participation
  • Pregnant or lactating women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Actively Recruiting

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Research Team

L

Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Long-term Safety and Tolerability of HSK39297 in Patients With Paroxysmal Nocturnal Hemoglobinuria | DecenTrialz