Hematologic Diseases Clinical Trial
Official title:
A Safety and Efficacy Study of N-acetylcysteine in Patients With Transplant-Associated Thrombotic Microangiopathy
Verified date | December 2021 |
Source | The First Affiliated Hospital of Soochow University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | October 1, 2021 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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; |
Country | Name | City | State |
---|---|---|---|
China | The First affiliated Hospital of SooChow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University |
China,
Acedillo RR, Govind M, Kashgary A, Clark WF. Treatment of severe, refractory and rapidly evolving thrombotic thrombocytopenic purpura. BMJ Case Rep. 2016 Jun 9;2016. pii: bcr2016215491. doi: 10.1136/bcr-2016-215491. — View Citation
George JN, López JA, Konkle BA. N-Acetylcysteine: an old drug, a new insight, a potentially effective treatment for thrombotic thrombocytopenic purpura. Transfusion. 2014 May;54(5):1205-7. doi: 10.1111/trf.12561. — View Citation
Rottenstreich A, Hochberg-Klein S, Rund D, Kalish Y. The role of N-acetylcysteine in the treatment of thrombotic thrombocytopenic purpura. J Thromb Thrombolysis. 2016 May;41(4):678-83. doi: 10.1007/s11239-015-1259-6. — View Citation
Tersteeg C, Roodt J, Van Rensburg WJ, Dekimpe C, Vandeputte N, Pareyn I, Vandenbulcke A, Plaimauer B, Lamprecht S, Deckmyn H, Lopez JA, De Meyer SF, Vanhoorelbeke K. N-acetylcysteine in preclinical mouse and baboon models of thrombotic thrombocytopenic purpura. Blood. 2017 Feb 23;129(8):1030-1038. doi: 10.1182/blood-2016-09-738856. Epub 2016 Dec 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Incidence of TA-TMA. | The incidence of TMA after HSCT. | 100 days | |
Secondary | The Level of VWF Multimers | The level of VWF multimers in patients post HSCT. | 100 days | |
Secondary | The Level of Endothelial Micro Particle | The level of endothelial micro particle in patients post HSCT. | 100 days | |
Secondary | The Level of TNF-a | The level of TNF-a in patients post HSCT. | 40 days | |
Secondary | The Level of ROS | The level of ROS in patients post HSCT. | 100 days |
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