Phase 3
N=160
A Safety and Efficacy Study of NAC in Patients With TA-TMA
Thrombotic Microangiopathies · Hematologic Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03252925 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: The Incidence of TA-TMA. — 5; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- N-Acetylcysteine (Drug); Placebo Oral Tablet (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- The First Affiliated Hospital of Soochow University
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of TA-TMA. |
5; 15 | — |
| SECONDARY The Level of VWF Multimers |
— | — |
| SECONDARY The Level of Endothelial Micro Particle |
— | — |
| SECONDARY The Level of TNF-α |
0.4; 0.3 | — |
| SECONDARY The Level of ROS |
— | — |
Summary
HSCT associated thrombotic microangiopathy(TA-TMA) is a heterogeneous, fatal disorder seen within 100 days post-transplant and presents with thrombocytopenia, hemolysis, acute renal failure, mental status changes and involvement of other organs. N-Acetylcysteine (NAC) is a small, simple molecule that began as a generic drug almost 40 years ago. It has since been approved by the FDA for many indications. The investigators conducted an prospective clinical trial to evaluate the safety and efficiency of NAC in patients with TA-TMA.
Eligibility Criteria
Inclusion Criteria
- Patients be scheduled to undergo HSCT;
- Not received decitabine 6 month ago;
- Without severe organ damage;
- ECOG 0-2;
- Informed consent were obtained.
Exclusion Criteria
- Be sensitive to NAC;
- Bronchial asthma；
- Peptic ulcer；
- Severe organ damage；
- Pregnancy and breastfeeding women；
Data sourced from ClinicalTrials.gov (NCT03252925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.