Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00449904 · ClinicalTrials.gov registry record · Phase 3
Open-Label Phase III Long-Term Safety Trial of Liprotamase
A Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, sponsored by Anthera Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
- 20
- Study locations
NCT00449904: Completed Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, sponsored by Anthera Pharmaceuticals.
NCT00449904 is a Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency that has completed, run by Anthera Pharmaceuticals. The registered enrollment target is 214 participants, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00449904, a Phase 3 study of Cystic Fibrosis and Exocrine Pancreatic Insufficiency, has completed, sponsored by Anthera Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
Conditions Studied
Interventions
- DRUG Liprotamase
Study Locations (20)
Illinois
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Chicago
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Glenview
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Niles
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Oak Lawn
Michigan
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Ann Arbor
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Detroit
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Detroit
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Kalamazoo
Florida
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Jacksonville
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Miami
Georgia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Atlanta
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Augusta
California
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Oakland
Colorado
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Denver
Idaho
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Boise
Indiana
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2007-06 |
| Est. Completion | 2009-04 |
| Phase | Phase 3 |
What the finished NCT00449904 record still lists
NCT00449904 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, above the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (20% higher).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Liprotamase is the first listed.
NCT00449904 names 20 study sites across 12 states, led by Illinois, Michigan, Florida.
Frequently Asked Questions
What is clinical trial NCT00449904 about?
NCT00449904 is a clinical study titled "Open-Label Phase III Long-Term Safety Trial of Liprotamase". This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
What is the current status of trial NCT00449904?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2007-06. Estimated completion is 2009-04.
What conditions does trial NCT00449904 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Exocrine Pancreatic Insufficiency.
What interventions are being tested in trial NCT00449904?
The interventions under investigation include: Liprotamase (DRUG).
Who is sponsoring clinical trial NCT00449904?
This trial is sponsored by Anthera Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00449904 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00449904's enrollment target sits among peer trials
214 33rd of 169 higher than 137 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Assessing Tenapanor as a Treatment of CF-related Constipation.
RECRUITING · Phase 3
-
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
RECRUITING · Phase 3
-
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
ACTIVE NOT RECRUITING · Phase 3
-
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
COMPLETED · Phase 3
-
Study of Ataluren (PTC124™) in Cystic Fibrosis
COMPLETED · Phase 3
-
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
COMPLETED · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04030507 · 214 participants · NA
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
- NCT04421248 · 214 participants · Phase 4
Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder
- NCT04667520 · 214 participants · NA
Testing a Lifestyle Physical Activity Intervention for Women With Depression in Alcohol Treatment
- NCT05418868 · 214 participants · Phase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia