A Safety and Efficacy Study of NAC in Patients With TA-TMA

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Soochow University
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

1. Patients be scheduled to undergo HSCT;

2. Not received decitabine 6 month ago;

3. Without severe organ damage;

4. ECOG 0-2;

5. Informed consent were obtained.

Exclusion Criteria:

1. Be sensitive to NAC;

2. Bronchial asthma；

3. Peptic ulcer；

4. Severe organ damage；

5. Pregnancy and breastfeeding women；