Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370825
Status:
COMPLETED
Last Update Posted:
2008-09-12
First Post:
2006-08-31
Brief Title:
Combination Chemotherapy for the Treatment of Indian Kala-Azar
Sponsor:
Banaras Hindu University
Organization:
Banaras Hindu University
Study Overview
Official Title:
Combination Chemotherapy for the Treatment of Indian Visceral Leishmaniasis Miltefosine Plus Liposomal Amphotericin B - Dose and Duration Ranging Study
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 investigators are using a sequential design to combine miltefosine and AmBisome in different doses
Detailed Description:
In this sequential design four arm study one arm is a reference arm but the three arms will consist an of initial dose of liposomal amphotericin B on first day followed by miltefosine Both the drugs will be used in different doses Reference arm will consist only a single dose of amBisome at 5 mgkg After the end of treatment the post treatment assessment will be done on day 16 initial cure and six months final cure Safety parameters will be evaluated on day 0 8 and 16 An arm with an efficacy of less than 75 will be closed There will be periodical assessment of study results after completion of 5 patients in each arm
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