Alpha1-Proteinase Inhibitor for Alpha-1 Antitrypsin Deficiency

(SWIFT-SC Trial)

Not yet recruiting at 18 trial locations

Overseen By Elsa Mondou

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Grifols Therapeutics LLC

Must be taking: Alpha1-PI augmentation

Must not be taking: Systemic steroids, Aerosolized antibiotics

Disqualifiers: COPD exacerbation, Lung transplant, Liver transplant, Severe liver enzymes, Severe concomitant disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.

Adults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given.

The main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Willing and able to provide written informed consent indicating that they understand the purpose of, and procedures required for the study and are willing to participate in it.

* All participants must have a documented total alpha1-PI serum level \<11 μM (80mg/dL if measured by radial immunodiffusion or 50 mg/dL if measured by nephelometry) which is documented pre-alpha1-PI augmentation for participants receiving AAT augmentation.

I am willing to stop my alpha1-PI therapy during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 weeks of IV treatment followed by 8 weeks of SC treatment with Alpha1-Proteinase Inhibitor

16 weeks

Weekly visits for treatment administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alpha1-Proteinase Inhibitor

How Is the Trial Designed?

Group I: Treatment Arm 2 Experimental Treatment 2 Interventions

8 weeks of IV treatment with 120 mg/kg/week Liquid Alpha1-PI followed by 8 weeks of SC treatment with 180 mg/kg/week Alpha-1 15%

Group II: Treatment Arm 1 Experimental Treatment 2 Interventions

8 weeks of IV treatment with 60 mg/kg/week Liquid Alpha1-PI followed by 8 weeks of SC treatment with 90 mg/kg/week Alpha-1 15%

Who Is Running the Clinical Trial?

Grifols Therapeutics LLC

Lead Sponsor

Trials

59

Recruited

6,000+