Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT07470762

Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Led by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Updated on 2026-04-13

50

Participants Needed

1

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This was a phase 1b/2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.

CONDITIONS

Official Title

Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 18 to 75 years
  • Diagnosis of PNH confirmed by flow cytometry with clone size ≥10% in red blood cells, granulocytes, or monocytes
  • Stable use of C5 complement inhibitor (ikuzumab/covalimab) for at least 6 months before randomization
  • At least one blood transfusion within the last 4 months or hemoglobin below 100 g/L in the last 4 months prior to screening
  • Average hemoglobin level from two lab tests at screening less than 100 g/L or hemoglobin <100 g/L before transfusion
  • Lactate dehydrogenase (LDH) above 1.5 times the upper limit of normal at screening
  • Received Neisseria meningitis and Streptococcus pneumoniae vaccines at least 2 weeks before first HS-10542 administration
  • If starting HS-10542 treatment less than 2 weeks after vaccination, preventive antibiotics must begin at least 2 weeks after vaccination
  • Fertile men and women must agree to effective contraception from informed consent signing until last drug administration
  • Infertile men (e.g., sterilized) must use additional contraception when sperm presence is uncertain
Not Eligible

You will not qualify if you...

  • Known or suspected hereditary or acquired complement deficiency
  • Active primary or secondary immunodeficiency
  • History of infections with pathogenic bacteria such as Neisseria meningitis or Streptococcus pneumoniae
  • Laboratory evidence of bone marrow failure (reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L)
  • Diagnosis of bone marrow failure disorders (e.g., aplastic anemia, myelodysplastic syndrome, myelofibrosis)
  • Active anemia unrelated to PNH, such as renal anemia or anemia due to blood loss
  • Systemic active bacterial, viral, or fungal infection within 2 weeks before first HS-10542 dose
  • Advanced heart disease (e.g., NYHA class IV)
  • Unstable thrombosis events of other causes
  • Abnormal ECG with QTcF >450 msec (males) or >470 msec (females), or other significant abnormalities
  • Major surgery within 3 months prior to first dose
  • Known active infection requiring systemic treatment
  • Malignant tumors diagnosed in past 5 years
  • History of splenectomy or bone marrow/hematopoietic stem cell or solid organ transplantation
  • Severe or poorly controlled hypertension
  • Poorly controlled diabetes
  • Suspected allergy to experimental drug or ingredients
  • Use of certain drugs without stable treatment before screening, including erythropoietin, HIF-PHI, immunosuppressants, systemic glucocorticoids >15 mg/day prednisone equivalent, vitamin K antagonists, anticoagulants, iron supplements, vitamin B12, folic acid, or androgens
  • Participation in other clinical trials or use of other investigational drugs within 5 half-lives or 2 weeks before screening (except stable C5 inhibitors)
  • Previous B-factor inhibitor treatment less than 1 week or stopped less than 5 half-lives before screening
  • Serious concurrent diseases such as severe kidney disease (eGFR <30 mL/min/1.73 m2, dialysis)
  • ALT or ALP greater than 3 times upper limit of normal
  • Positive pregnancy test or breastfeeding at screening

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，Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

Y

Yan Hong Tong

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

1

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Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria | DecenTrialz