Trial Profile
An Open-Label, Multicenter Study to Evaluate the Long-term Safety of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency
Status:
Recruiting
Phase of Trial:
Phase III
Latest Information Update: 31 Jan 2024
Price :
$35
*
At a glance
- Drugs Alpha 1-antitrypsin (Primary)
- Indications Alpha 1-antitrypsin deficiency; Emphysema
- Focus Adverse reactions; Registrational
- Acronyms SPARTA-OLE
- Sponsors Grifols
- 24 Jan 2024 Planned End Date changed from 1 Jul 2028 to 1 Feb 2029.
- 24 Jan 2024 Planned primary completion date changed from 1 Jul 2028 to 1 Sep 2028.
- 03 Nov 2023 Planned number of patients changed from 250 to 290.