Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453375
Status:
COMPLETED
Last Update Posted:
2011-06-28
First Post:
2007-03-26
Brief Title:
Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus
Sponsor:
Bayhill Therapeutics
Organization:
Bayhill Therapeutics
Study Overview
Official Title:
A Randomized Blinded Placebo Controlled Safety and Pharmacodynamic Study of BHT-3021 With Open Label Cross-Over in Subjects With Type I Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2011-01
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 to determine the safety of BHT-3021 injections given weekly for 12 weeks and to evaluate the effect of BHT-3021 on antibody and immune T cell responses to autoantigens eg insulin Changes in pancreatic beta cell function insulin requirements and blood glucose levels will also be evaluated
Detailed Description:
Type 1 diabetes results from an attack by the bodys own immune system on the insulin producing cells in the pancreas Around 80 of diagnosed patients have detectable antibodies to islet cell self-proteins including insulin IA-2 and glutamic acid decarboxylase The drug BHT-3021 is being studied because an agent that stops autoimmune damage could offer patients benefit
Study Description A Randomized Blinded Placebo Controlled Safety and Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with Type I Diabetes Mellitus that will enroll up to 72 subjects in this trial Subjects will be randomized to BHT-3021 or BHT-placebo in a 21 ratio
The duration of the study is approximately 25 to 37 months depending on treatment assignment 4 week Screening Period 12 month Blinded Treatment and Evaluation Period 12 month Cross-over Treatment and Evaluation Period BHT-placebo subjects only 12 month Long Term Follow-Up period
Study Description A Randomized Blinded Placebo Controlled Safety and Pharmacodynamic Study of BHT-3021 with Open Label Cross-Over in Subjects with Type I Diabetes Mellitus that will enroll up to 72 subjects in this trial Subjects will be randomized to BHT-3021 or BHT-placebo in a 21 ratio
The duration of the study is approximately 25 to 37 months depending on treatment assignment 4 week Screening Period 12 month Blinded Treatment and Evaluation Period 12 month Cross-over Treatment and Evaluation Period BHT-placebo subjects only 12 month Long Term Follow-Up period
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