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

NCT03252925 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2022-02-14

Study results available
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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.

Conditions

Interventions

DRUG

N-Acetylcysteine

50mg/Kg.d, oral

DRUG

Placebo Oral Tablet

50mg/Kg.d, oral

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Depei Wu, MD. PhD. · The First Affiliated Hospital of Soochow University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2021-10-01
Completion
2021-10-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03252925 on ClinicalTrials.gov