A Phase 3 interventional study of N acetyl cysteine in Mucositis and Transplant-Related Disorder, sponsored by moshe yeshurun. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-16.
Sponsored by moshe yeshurun · Phase 3, Interventional, and Prevention
Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.
488 studies on the registry are indexed under Mucositis; 70 are open to participants now.
This study's planned enrollment of 116 is above the median of 50 across 394 interventional studies indexed under Mucositis.
Browse Mucositis studies →moshe yeshurun is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NAC dissolved in water at a dose of 600 mg three times per day from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.
Drug: N acetyl cysteine
No intervention
N acetyl cysteine dissolved in water at a dose of 600 mg three times daily from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.
Proportion of patients with grade 3-4 OM
Proportion of patients with grade 3-4 OM
Time frame: day 14
Proportion of patients with grade 1-4 OM
Proportion of patients with grade 1-4 OM
Time frame: 14 days
Time from transplantation to first hospital discharge
Time from transplantation to first hospital discharge
Time frame: 30 days
Non-relapse mortality
Non-relapse mortality
Time frame: day 50
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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moshe yeshurun