Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00497601
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2007-07-05
Brief Title:
A Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Kala-Azar
Sponsor:
Banaras Hindu University
Organization:
Banaras Hindu University
Study Overview
Official Title:
A Prospective Single Center Open-Label Dose-Escalation Phase II Study To Assess Safety and Efficacy Of Short-Course Regimens Of Amphotericin B Emulsion In Treatment Naïve Or Resistant Cases Of Visceral Leishmaniasis Kala-Azar
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
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:
None
Brief Summary:
The purpose of this study is
1 To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar visceral leishmaniasis subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations
2 To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar
1 To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar visceral leishmaniasis subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations
2 To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar
Detailed Description:
1 To evaluate the Safety and Efficacy of four different short-course regimens of Amphotericin B emulsion in treatment of Kala-azar visceral leishmaniasis subjects who are either treatment naive or treatment resistant to other antileishmanial drugs except amphotericin B containing preparations
2 To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar
Subjects will be administered the study drug in either of the following four dose levels in an ascending manner starting with the first dosage regimen
75 mgkg on day 1 and day3 Regimen 1
10 mgkg on day 1 followed by 5 mgkg on day 3 Regimen 2
125 mgkg on day 1 followed by 25 mgkg on day 3 Regimen 3
Single-bolus infusion of 15 mgkg over 2-4 hours on day 1 Regimen 4
2 To assess the safety and efficacy of single-bolus infusion of Amphotericin B emulsion in treatment of Kala-azar
Subjects will be administered the study drug in either of the following four dose levels in an ascending manner starting with the first dosage regimen
75 mgkg on day 1 and day3 Regimen 1
10 mgkg on day 1 followed by 5 mgkg on day 3 Regimen 2
125 mgkg on day 1 followed by 25 mgkg on day 3 Regimen 3
Single-bolus infusion of 15 mgkg over 2-4 hours on day 1 Regimen 4
Study Oversight
Has Oversight DMC:
None
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?:
None