Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449878
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2007-03-19
Brief Title:
Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Sponsor:
Anthera Pharmaceuticals
Organization:
Anthera Pharmaceuticals
Study Overview
Official Title:
A Phase III Randomized Double-Blind Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
Status:
COMPLETED
Status Verified Date:
2014-10
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:
DIGEST
Brief Summary:
This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis CF patients with exocrine pancreatic insufficiency PI
Detailed Description:
This trial is divided into four distinct periods
1 Baseline Period during which each patient is taken off pancreatic enzyme medications
2 An Open-Label Treatment Period during which all patients will receive ALTU-135 liprotamase
3 Inpatient Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo
4 Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 liprotamase
1 Baseline Period during which each patient is taken off pancreatic enzyme medications
2 An Open-Label Treatment Period during which all patients will receive ALTU-135 liprotamase
3 Inpatient Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo
4 Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 liprotamase
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 726 | OTHER | AltusAlnara | None |
| I5L-MC-TCAB | OTHER | None | None |