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NCT07279610
N-Acetylcysteine as Therapy for Transplantation- Associated Thrombotic Microangiopathy
Phase 2, PHASE3 trial testing N-Acetylcysteine (NAC) Treatment in Thrombotic Microangiopathy in 44 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2026
Quick facts
| Lead sponsor | The First Affiliated Hospital of Soochow University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 1 May 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- N-Acetylcysteine (NAC) Treatment — full drug profile →
Conditions studied
- Thrombotic Microangiopathy — all drugs for Thrombotic Microangiopathy →
Sponsor
The First Affiliated Hospital of Soochow University
Who can join
18 and older, any sex, with Thrombotic Microangiopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This multicenter, prospective, single-arm clinical trial aims to evaluate the efficacy and safety of N-acetylcysteine (NAC) for treating Transplantation-Associated Thrombotic Microangiopathy (TA-TMA), a severe complication of hematopoietic stem cell transplantation characterized by microangiopathic hemolytic anemia, thrombocytopenia, and organ injury, with an incidence of 4%-30%. Current treatments, including plasma exchange (response rate \<10%) and costly complement inhibitors like Eculizumab (71% response) which are not widely accessible, are inadequate. Inspired by NAC's success in treating the related condition thrombotic thrombocytopenic purpura (TTP) and supported by bioinformatic analyses of patient data revealing enhanced oxidative stress pathways and identifying NAC as a potential targeted therapy, our prior study demonstrated that NAC prophylaxis significantly reduces TA-TMA incidence and improves survival. Building on this promising foundation, this study will enroll patients meeting TA-TMA diagnostic criteria for NAC treatment, assessing its potential as a safe, effective, and affordable therapeutic option.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07279610
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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Other The First Affiliated Hospital of Soochow University trials
Trials by the same sponsor.
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- NCT07500753 — A Single-arm, Prospective Study of a Clad-LABU Conditioning Regimen in HSCT for R/R MDS/AML in Elderly Patients · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07279610 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The First Affiliated Hospital of Soochow University
- Last refreshed: 12 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07279610.
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