Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT01138956
Status:
UNKNOWN
Last Update Posted:
2010-06-08
First Post:
2010-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immune Response of Visceral Leishmaniasis PatientsTreated With Antimonial Plus N-Acetylcysteine
Sponsor:
Hospital Universitário Professor Edgard Santos
Organization:
Study Overview
Official Title:
Study for Evaluation of the Immune Response of Visceral Leishmaniasis Patients Treated With Antimonial Pentavalent Associated to N-Acetylcysteine
Status:
UNKNOWN
Status Verified Date:
2010-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VLNAC
Brief Summary:
This study is designed to evaluate the immune and therapeutic responses of visceral leishmaniasis patients using N-acetylcysteine (NAC) as an adjuvant therapy to pentavalent antimony.
Detailed Description:
In this study we intend to evaluate the immune and therapeutic responses of patients with visceral leishmaniasis N-acetylcysteine (NAC) as an adjuvant to standard treatment with pentavalent antimony, compared to treatment with antimonial only through a blind randomized clinical trial. Our hypothesis is that patients treated with NAC associated with pentavalent atimonial have a rapid changing of the immune responses, towards TH1, and clinical improvement when compared to patients who will use only the standard treatment
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: