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Proteinase Inhibitor

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

Phase 3
Waitlist Available
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
Must not have
Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception throughout the study.
Has clinical signs and symptoms of viral infection requiring virus safety testing at the Week 160/End-of-Study Visit or Early Discontinuation Visit in Study GTi1201, and the virus safety test results are indicative of acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52 and week 104
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial is an extension of a previous one; it's open-label (meaning participants know what they're taking), multicenter (at multiple sites), and aims to collect safety data on Alpha1-MP, a drug given to people with a deficiency of alpha1-antitrypsin.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While the specific side effects are not listed here, generally intravenous medications like Alpha1-MP could cause reactions at the injection site, allergic responses including anaphylaxis if there's a history of such reactions to plasma-derived products.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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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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I show signs of a viral infection and tested positive for HAV, HBV, HCV, HIV, or B19V.
Select...
I have lung cancer or another cancer with less than 1 year expected survival.
Select...
I do not have severe diseases like heart failure or liver cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52 and week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 and week 104 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events (AEs)
Discontinuations from the study due to AEs
Serious AEs (SAEs)
Secondary study objectives
Change from baseline in Saint George's Respiratory Questionnaire
Change from baseline in carbon monoxide diffusing capacity (DLco)
Change from baseline in the EQ-5D-5L Questionnaire
+3 more

Side effects data

From 2007 Phase 3 trial • 24 Patients • NCT00295061
8%
Upper respiratory tract infection
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alpha-1 MP
Prolastin

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Alpha-1 MPExperimental Treatment1 Intervention
Alpha-1 MP 60 mg/kg/week for up to 104 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alpha-1 MP
2016
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

Grifols Therapeutics LLCLead Sponsor
58 Previous Clinical Trials
5,818 Total Patients Enrolled

Media Library

Alpha-1 MP (Proteinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02796937 — Phase 3
Alpha-1 Antitrypsin Deficiency Research Study Groups: Alpha-1 MP
Alpha-1 Antitrypsin Deficiency Clinical Trial 2023: Alpha-1 MP Highlights & Side Effects. Trial Name: NCT02796937 — Phase 3
Alpha-1 MP (Proteinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02796937 — Phase 3
~89 spots leftby Sep 2028
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