Trial · NCT03252925

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

NCT03252925, Phase 3, Completed, The First Affiliated Hospital of Soochow University; results first posted 2022-02-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety and Efficacy Study of NAC in Patients With TA-TMA. Trials, record NCT03252925. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03252925

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Efficacy Study of NAC in Patients With TA-TMA
NCT number: NCT03252925
Status: Completed
Phases: Phase 3
Enrollment: 170 participants, actual
Lead sponsor: The First Affiliated Hospital of Soochow University
Conditions: Thrombotic Microangiopathies, Hematologic Diseases
Interventions: N-Acetylcysteine, Placebo Oral Tablet
First posted: 2017-08-17
Last updated: 2022-02-14
Results first posted: 2022-02-14
Limitations and caveats: Several outcome indicators are entirely inconsistent with our study's actual course of execution. First, the occurrence of TA-TMA was not limited to the first 100 days after hematopoietic stem cell transplantation. Secondly, the detection of VWF multimers, endothelial microparticles, and ROS was not performed according to the protocol.

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	The Incidence of TA-TMA.	100 days	The incidence of TMA after HSCT.
Secondary	The Level of VWF Multimers	100 days	The level of VWF multimers in patients post HSCT.
Secondary	The Level of Endothelial Micro Particle	100 days	The level of endothelial micro particle in patients post HSCT.
Secondary	The Level of TNF-α	40 days	The level of TNF-α in patients post HSCT.
Secondary	The Level of ROS	100 days	The level of ROS in patients post HSCT.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	The Incidence of TA-TMA.	100 days	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	The Level of VWF Multimers	100 days
SECONDARY	The Level of Endothelial Micro Particle	100 days
SECONDARY	The Level of TNF-α	40 days	pg/mL	MEDIAN
SECONDARY	The Level of ROS	100 days

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
The Incidence of TA-TMA.	NAC Group	5		Participants
The Incidence of TA-TMA.	Placebo Group	15		Participants
The Level of TNF-α	NAC Group	0.4	Inter-Quartile Range 0 to 1.4	pg/mL
The Level of TNF-α	Placebo Group	0.3	Inter-Quartile Range 0 to 2.1	pg/mL

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Experimental Group	80
Overall Study	STARTED	Control Group	80
Overall Study	COMPLETED	Experimental Group	66
Overall Study	COMPLETED	Control Group	74
Overall Study	NOT COMPLETED	Experimental Group	14
Overall Study	NOT COMPLETED	Control Group	6

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain or diarrhea	Gastrointestinal disorders	NAC Group	36	66
other	Abdominal pain or diarrhea	Gastrointestinal disorders	Placebo	49	74
other	Hemorrhagic cystitis	Renal and urinary disorders	NAC Group	27	66
other	Hemorrhagic cystitis	Renal and urinary disorders	Placebo	43	74
other	Fever	Blood and lymphatic system disorders	NAC Group	20	66
other	Fever	Blood and lymphatic system disorders	Placebo	37	74
other	Upper gastrointestinal complications	Gastrointestinal disorders	NAC Group	3	66
other	Upper gastrointestinal complications	Gastrointestinal disorders	Placebo	18	74
other	Erythra	Blood and lymphatic system disorders	NAC Group	11	66
other	Erythra	Blood and lymphatic system disorders	Placebo	15	74

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NAC Group	16	66
Total, all-cause mortality	Placebo	27	74
Total, other adverse events	NAC Group	59	66
Total, other adverse events	Placebo	72	74
Total, serious adverse events	NAC Group	0	66
Total, serious adverse events	Placebo	0	74

Source ClinicalTrials.gov

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
24819072	BACKGROUND	PubMed
26245827	BACKGROUND	PubMed
27284100	BACKGROUND	PubMed
28011677	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
NAC Group vs Placebo Group: The Incidence of TA-TMA.	Trial comparisons
NAC Group vs Placebo: deaths from any cause	Trial comparisons
NAC Group vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03252925

GET https://conductscience.org/api/trials/v1/NCT03252925/registered

API reference For AI assistants