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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52 and week 104
Awards & highlights

SPARTA-OLE Trial 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.Check my eligibility
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.See study design
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.

SPARTA-OLE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events (AEs)
Discontinuations from the study due to AEs
Serious AEs (SAEs)
Secondary outcome measures
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

SPARTA-OLE 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
57 Previous Clinical Trials
5,518 Total Patients Enrolled
3 Trials studying Pulmonary Emphysema
452 Patients Enrolled for Pulmonary Emphysema

Media Library

Alpha-1 MP (Proteinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02796937 — Phase 3
Pulmonary Emphysema Research Study Groups: Alpha-1 MP
Pulmonary Emphysema 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the United States FDA given the okay to market Alpha-1 MP?

"There is a significant amount of data suggesting that Alpha-1 MP is safe, as this is a Phase 3 trial."

Answered by AI

Does this research allow for octogenarians to participate?

"This particular trial is only for patients aged 20 to 72. However, there are 3 other trials that welcome patients under the age of 18 and 41 that cater to patients over 65 years old."

Answered by AI

Could you tell me how many test subjects are involved in this experiment?

"That is accurate. The clinical trial, which was originally posted on 7/1/2016 and updated on 9/20/2022, is recruiting for a total of 192 participants from 7 different locations, as indicated by the data from clinicaltrials.gov."

Answered by AI

Is this the first time that Alpha-1 MP has been trialed?

"Alpha-1 MP was first studied in 2013 at the Clinic Dr.G Curteanu Oradea. Since then, there have been a total of 25 completed trials. Out of the 5 active trials, a large number are taking place in Phoenix, Arizona."

Answered by AI

What is the primary focus of this clinical trial?

"As of now, 5 different Alpha-1 MP trials are ongoing in 34 cities and 17 countries. The very first Alpha-1 MP clinical trial began in 2013. That year, the study completed its Phase 3 drug approval stage--339 patients were involved and it was sponsored by Grifols Therapeutics LLC. In the 8 years since 2013, 25 different Alpha-1 MP trials have concluded."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
How old are they?
18 - 65
What site did they apply to?
Oregon Health & Science University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency
2016. "Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02796937.
All > Arizona > Emphysema
~103 spots leftby Sep 2028
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