Alpha-1 MP Safety for Alpha-1 Antitrypsin Deficiency
(SPARTA-OLE Trial)

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Grifols Therapeutics LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a 2-year open-label, multicenter extension of the double-blind, placebo-controlled GTi1201 study. The purpose of this study is to obtain an additional 2 years of safety data for intravenously administered Alpha1-MP 60 mg/kg/week in subjects with alpha1-antitrypsin deficiency (AATD).

Research Team

Eligibility Criteria

This trial is for individuals who have completed the GTi1201 study or shown a specific decline in lung function, and can consent to participate. It's not for those with certain metal implants, claustrophobia preventing CT scans, pregnant or non-contracepting women, smokers, substance abusers, other cancer patients with less than a year survival prediction, severe diseases like heart failure or liver cirrhosis, history of severe reactions to blood products, compliance issues with protocols or any condition that might risk their safety or skew results.

Inclusion Criteria

Is willing and able to provide informed consent

You have been in another study for a certain amount of time, or your lung function has declined at a specific rate in a previous study.

Exclusion Criteria

Is currently participating in another investigational product (IP) study.

I have a new metal object in my body that could affect chest CT scans.

I am not pregnant, breastfeeding, and if I can have children, I agree to use effective birth control during the study.

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Treatment Details

Interventions

Alpha-1 MP (Proteinase Inhibitor)

Trial OverviewThe trial is testing the long-term safety of Alpha1-MP (a medication given through veins) at a dose of 60 mg/kg/week over two years in people with alpha-1 antitrypsin deficiency which can lead to conditions like emphysema.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Alpha-1 MPExperimental Treatment1 Intervention

Alpha-1 MP 60 mg/kg/week for up to 104 weeks