Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 3:04 PM
Study NCT ID:
NCT01459133
Status:
WITHDRAWN
Last Update Posted:
2015-03-17
First Post:
2011-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System
Sponsor:
South Orange County Endocrinology
Organization:
Study Overview
Official Title:
Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to register Treatment IND with the US Food And Drug Administration's new process of establishing TLS encryption for email correspondence.
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 program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. Treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.
Detailed Description:
This program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. The treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject.
INVESTIGATIONAL PRODUCT DESCRIPTION:
Technosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.
INVESTIGATIONAL PRODUCT DESCRIPTION:
Technosphere® Insulin Inhalation System includes Technosphere® Insulin Inhalation Powder and inhaler. The Inhalation Powder comes in 10 unit and 20 unit cartridges.
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?: