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Proteinase Inhibitor

Prolastin-C, 120 mg/kg for Pulmonary Fibrosis and Emphysema (SPARK Trial)

Phase 2

Waitlist Available

Led By Mark Brantly, MD

Research Sponsored by Grifols Therapeutics LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 8 and week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of Prolastin-C (alpha1-proteinase inhibitor \[alpha1-PI\] \[Human\]), compared to weekly infusions of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).

Eligible Conditions

Pulmonary Fibrosis and Emphysema
Emphysema
Alpha-1 Antitrypsin Deficiency

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 8 and week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 8 and week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8 and week 18 at the following timepoints: 0 (pre-infusion), completion of first infusion bag, completion of 2nd infusion bag, and 15 min, 30 min, and 1, 2, 4, 8, 24, 48, 120, and 168 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Drug-related TEAEs

Number of TEAEs

Number of Treatment-Emergent Pulmonary Exacerbations

+6 more

Secondary study objectives

AUC0-7days

Mean Trough

Side effects data

From 2012 Phase 2 trial • 30 Patients • NCT01213043

23%

COPD Exacerbation

10%

Urinary Tract Infection

Proteinuria

Thrombocytopenia

Contusion

100%

80%

60%

40%

20%

Study treatment Arm

60 mg/kg Prolastin-C

120 mg/kg Prolastin-C

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Prolastin-C, 120 mg/kgExperimental Treatment1 Intervention

120 mg/kg weekly infusion of Prolastin-C for 8 weeks. Subjects were infused with 120 mg/kg Prolastin-C by means of one of two possible treatment sequences: 1) 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120 mg/kg Prolastin-C for 8 weeks, or 2) 120 mg/kg Prolastin-C for 8 weeks followed by 60 mg/kg weekly infusion of Prolastin-C for 8 weeks (total of 16 weeks).

Group II: Prolastin-C, 60 mg/kgActive Control1 Intervention

60 mg/kg weekly infusion of Prolastin-C for 8 weeks. Subjects were infused with 60 mg/kg Prolastin-C by means of one of two possible treatment sequences: 1) 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120 mg/kg Prolastin-C for 8 weeks, or 2) 120 mg/kg Prolastin-C for 8 weeks followed by 60 mg/kg weekly infusion of Prolastin-C for 8 weeks (total of 16 weeks).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Benzalkonium

FDA approved

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