CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 170 enrolled
Drug / intervention
N-Acetylcysteine +1 moredrug
Likely dose
N-Acetylcysteine 50mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03252925
NCT03252925Phase 3Completed

A Safety and Efficacy Study of N-acetylcysteine in Patients With Transplant-Associated Thrombotic Microangiopathy

The First Affiliated Hospital of Soochow University·interventional·Posted Aug 17, 2017·Updated Feb 14, 2022

In Brief

A Phase 3 clinical trial evaluating N-Acetylcysteine and Placebo Oral Tablet for Thrombotic Microangiopathies and Hematologic Diseases. Completed, enrolled 170 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 17, 2017
Enrollment StartNov 1, 2017
Primary CompletionOct 1, 2021
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 8.9 years ago

Interventions

N-Acetylcysteinedrug

50mg/Kg.d, oral

Placebo Oral Tabletdrug

50mg/Kg.d, oral