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Tests treatment safety and results for Paroxysmal Nocturnal Hemoglobinuria
Official title Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria
ClinicalTrials.gov ID: NCT07470762
What this study is testing
What is HS-10542?
HS-10542 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for paroxysmal nocturnal hemoglobinuria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men or women aged more than or equal to (≥) 18 years, and less than (≤) 75 years.
- It was confirmed to be PNH during screening, and the clone size of red blood cells or/and granulocytes or/and monocytes was detected by flow cytopy...
- Stable use of C5 complement inhibitor ikuzumab/covalimab for the first 6 months of random treatment
- Have at least one blood transfusion record within the last 4 months, or sustain a hemoglobin level below 100g/L the last 4 months prior to screening.
- The average hemoglobin level from two tests conducted by the laboratory at the time of screening is less than 100 g/L, or hemoglobin level \<100g/L...
You likely can't join if
- Known or suspected hereditary or acquired complement deficiency
- Currently active primary or secondary immunodeficiency
- History of infection with pod bacteria (such as Neisseris meningitis, Streptococcus pneumoniae, etc.)
- Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
- Presence of a bone marrow failure disorder (e.g., aplastic anemia, myelodysplastic syndrome, myelofibrosis)
- Presence of active anemia unrelated to PNH, such as renal anemia or anemia due to blood loss.
See the full eligibility criteria
- Men or women aged more than or equal to (≥) 18 years, and less than (≤) 75 years.
- It was confirmed to be PNH during screening, and the clone size of red blood cells or/and granulocytes or/and monocytes was detected by flow cytopy ≥10%
- Stable use of C5 complement inhibitor ikuzumab/covalimab for the first 6 months of random treatment
- Have at least one blood transfusion record within the last 4 months, or sustain a hemoglobin level below 100g/L the last 4 months prior to screening.
- The average hemoglobin level from two tests conducted by the laboratory at the time of screening is less than 100 g/L, or hemoglobin level \<100g/L before transfusion.
- LDH \> 1.5 x Upper Limit of Normal (ULN) at the time of screening
- Inoccution of Neisseris meningitis and Streptococcus pneumoniae vaccine at least 2 weeks before the first administration of HS-10542;
- if HS-10542 treatment must begin less than 2 weeks after vaccination, preventive antibiotic treatment must begin at least 2 weeks after vaccination.
- Male and female people with fertility must agree to adopt efficient contraceptive measures with their partners within 60/120 days from the signing of the informed consent form to the last administration,
- Male people who are infertile (such as those who have undergone effective sterilization surgery) must take additional efficient contraceptive measures when it is uncertain whether they have sperm，
- Known or suspected hereditary or acquired complement deficiency
- Currently active primary or secondary immunodeficiency
- History of infection with pod bacteria (such as Neisseris meningitis, Streptococcus pneumoniae, etc.)
- Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
- Presence of a bone marrow failure disorder (e.g., aplastic anemia, myelodysplastic syndrome, myelofibrosis)
- Presence of active anemia unrelated to PNH, such as renal anemia or anemia due to blood loss.
- There is or is suspected of systemic active bacteria, virus or fungal infection 2 weeks before the first administration of HS-10542 (according to the researcher's judgment)
- During screening, there are advanced heart disease (such as NYHA level IV),
- unstable thrombosis events that may exist for other causes,
- Abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula \> 450 msec for males and \> 470 msec for females; or other clinically significant abnormalities as judged by the investigator.
- Major surgery within 3 months prior to the first dose. \ Note: See Appendix for definitions of Grade 3/4 surgeries.
- Known active infection requiring systemic therapy
- Diagnosed malignant tumors in the past 5 years
- Those who have a history of splenectomy or History of bone marrow/hematopoietic stem cells or solid organ transplantation
- Severe or poorly controlled hypertension
- poorly controlled diabetes
- Those who are suspected of being allergic to experimental drugs or any ingredient in experimental drugs
- Use any of the following drugs, unless there is a stable treatment plan before screening: a) erythropoietin (ESA), hypoxic-inducing factor proaminoyl hydroxylase inhibitor (HIF-PHI) or immunosuppressant for at least 8...
- Except for C5 complement inhibitors (including but not limited to ecucizumab and covalizumab), the situation of participating in other clinical trials or using other study drugs or approved therapies for experimental...
- Participants who have previously received B-factor inhibitor treatment, with a treatment duration of no more than one week and having stopped taking the drug for more than five half-lives before screening, may not be...
- During screening, there are serious concurrent diseases, such as severe kidney disease (such as eGFR\<30 mL/min/1.73 m2, dialysis),
- ALT/ALP\>3×ULN,
- Screening positive blood pregnancy test and breastfeeding women at the time of the visit,
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.