Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00034658
Status:
COMPLETED
Last Update Posted:
2017-03-10
First Post:
2002-05-01
Brief Title:
Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections Study P00041
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
Open Label Treatment Protocol for the Safety and Efficacy of Posaconazole SCH 56592 in the Treatment of Invasive Fungal Infections
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to evaluate the safety tolerance and efficacy of Posaconazole SCH 56592 under an open label treatment protocol for subjects with invasive fungal infections
A which are refractory or resistant to standard antifungal therapies B for which there are currently no effective therapies C with a prior history of serious severe or life-threatening toxicities while receiving antifungal therapy D with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies
A which are refractory or resistant to standard antifungal therapies B for which there are currently no effective therapies C with a prior history of serious severe or life-threatening toxicities while receiving antifungal therapy D with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies
Detailed Description:
The current clinical trial is designed to provide posaconazole SCH 56592 to subjects with invasive fungal infections awhich are refractory or resistant to standard antifungal therapies or b for which there are currently no effective therapies Subjects with such invasive fungal infections cannot be enrolled in controlled randomized clinical trials Secondly this clinical trial is also designed to provide posaconazole SCH 56592 to subjects with invasive fungal infections who c have experienced serious or severe toxicities while receiving standard antifungal therapies or d have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole SCH 56592 against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled randomized clinical trial
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