Cheap antioxidant could replace costly drugs for Post-Transplant blood disorder
NCT ID NCT07279610
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether N-acetylcysteine (NAC), a common antioxidant, can treat a severe blood vessel condition called TA-TMA that can happen after a stem cell transplant. Current treatments are either ineffective or very expensive. The trial will enroll 44 adults diagnosed with TA-TMA and measure if NAC improves blood counts and organ function. If successful, NAC could offer a safe, affordable option for this life-threatening complication.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- 1. Informed Consent: The patient must have the ability to understand and the willingness to participate in the study and must sign a written Informed Consent Form. 2\. Age: ≥ 18 years old, regardless of gender. 3. Diagnosis: Subjects diagnosed with TA-TMA according to the Harmonizing Definitions, defined as meeting one of the following: * TA-TMA confirmed by renal or intestinal biopsy, OR * Fulfilling at least four of the following seven clinical or laboratory criteria within a 14-day period: 1. Anemia, defined as persistent transfusion dependence after myeloid engraftment, OR a decrease in hemoglobin \>10 g/L, OR new-onset transfusion dependence. 2. Thrombocytopenia, defined as failure of platelet engraftment, OR a higher-than-expected platelet transfusion requirement, OR refractory platelet transfusion, OR a \>50% decrease in platelets after initial engraftment. 3. Lactate dehydrogenase (LDH) level above the upper limit of normal (ULN). 4. Presence of schistocytes on peripheral blood smear. 5. Hypertension (blood pressure ≥140/90 mmHg). 6. sC5b-9 level above the ULN. 7. Proteinuria (random urine protein-to-creatinine ratio ≥1 mg/mg). Exclusion Criteria: * 1\. The subject has received complement blockade therapy (e.g., Eculizumab or Narsoplimab) within the past 3 months. 2\. The subject has a history of drug and/or alcohol abuse within the 6 months prior to enrollment. 3\. The subject has a life expectancy of less than 3 months. 4. The subject is considered by the investigator to be unable or unwilling to cooperate with the study procedures. 5\. The subject is a family member or employee of the investigator. 6. The patient is pregnant or lactating. 7. The subject has a history of Human Immunodeficiency Virus (HIV) infection. 8. The subject has a known allergy to any component of the investigational drug (N-acetylcysteine). 9\. The subject has cardiac insufficiency, defined as an ejection fraction (EF) \<30%, or NYHA Class III or higher heart failure, or other cardiac conditions deemed by the investigator as unsuitable for enrollment. 10\. The subject has contraindications to N-acetylcysteine, such as active bronchial asthma or peptic ulcer disease. 11\. The patient refuses to participate in the study.
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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.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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