Can a new injection tame the blood cell destruction of PNH?
NCT ID NCT07796256
First seen Sep 01, 2026 · Last updated Sep 04, 2026 · Updated 2 times
Summary
This Phase II trial tests an experimental drug called SGB-9768 in adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder where red blood cells break apart too early. The study gives the drug by injection under the skin and measures how well it lowers a marker of red blood cell destruction called LDH. Researchers also track safety and side effects. The goal is to see if SGB-9768 can control PNH and improve symptoms like anemia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SGB-9768, an experimental drug given by injection under the skin
- What this could lead to
- If SGB-9768 works, it could offer a new treatment option for people with PNH, helping to control the disease and reduce symptoms like fatigue and anemia.
- What could go wrong
- This is an early-stage trial with only 24 participants, so the drug may not prove effective or safe. Possible risks include injection site reactions and infections, especially since the drug may affect the immune system.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male and female participants ≥ 18 years of age; 2. Diagnosis of PNH confirmed by flow cytometry, with a PNH clone size \>10% in granulocytes and/or monocytes; 3. Mean hemoglobin level \<100 g/L at screening. 4. Lactate Dehydrogenase (LDH) \> 1.5 x Upper Limit of Normal (ULN) at screening. 5. Complement inhibitor-naïve, or previous complement inhibitor therapy discontinued for more than 5 drug half-lives or 3 months before randomization. 6. Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given. Exclusion Criteria: 1. Patients with reticulocytes \<100x10⁹/L; platelets \<30x10⁹/L; neutrophils \<0.5x10⁹/L. 2. History of congenital asplenia or splenectomy. 3. Known or suspected hereditary or acquired complement deficiencies/abnormalities. 4. Active or recurrent invasive infections caused by encapsulated bacteria (e.g., Neisseria meningitidis, Streptococcus pneumoniae, or Haemophilus influenzae). 5. Active systemic bacterial, viral, or fungal infection within 14 days before randomization. 6. Evidence or history of tuberculosis infection (except adequately treated inactive tuberculosis with negative screening results). 7. Recurrent chronic infections within 1 year before screening. 8. Positive virology tests indicating active Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), or syphilis infection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
Tianjin, Tianjin Municipality, 300020, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
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