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New study checks safety of weekly infusion for rare lung disease

NCT ID NCT02796937

Disease control Sponsor: Grifols Therapeutics LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the long-term safety of a weekly intravenous treatment for people with emphysema caused by alpha-1 antitrypsin deficiency. About 290 adults who completed a prior study will receive the drug for 2 more years. The main goal is to monitor side effects, not to cure the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 290 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2016

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 72 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Has completed participation in Study GTi1201 (ie, completed Week 156 and Week 160/End-of-Study Visit) OR has experienced a decline in FEV1 at the annualized rate of ≥134.4 mL/year at or after the Week 104 Visit in GTi1201. * Is willing and able to provide informed consent Exclusion Criteria: * Is unable to physically or mentally undergo a CT scan (eg, unable to fit inside the CT scanner, claustrophobic). * Has severe concomitant disease including, but not limited to, congestive heart failure and liver cirrhosis. * Has primary and/or secondary (metastatic disease) pulmonary malignancy or other current malignancy with \<1 year predicted overall survival. * Has a metal object (newly received since starting GTi1201) that might interfere with chest CT quality and quantification. Metal objects include, but are not limited to, cardiac pacemaker, defibrillator, metal prosthetic heart valve, metal projectile, metal weapon fragments, or metal shoulder prosthesis. * Is a female who is pregnant, breastfeeding or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception; placement of an intrauterine device or intrauterine system; condom or occlusive cap with spermicidal foam/gel/film/cream/suppository; male sterilization; or abstinence) 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). Note: If the virus safety test results are indicative of acute or chronic infection with HAV, HBV, HCV, HIV, or B19V, the subject will be considered a screen failure and must be withdrawn from the study. * Has current evidence of smoking, which includes electronic/vapor cigarettes, or has a positive urine cotinine test at the Week 160/End-of- Study Visit in Study GTi1201 that is due to smoking. * Has current evidence of chronic alcoholism or illicit drug abuse (addiction). * Is currently participating in another investigational product (IP) study. * Has a history of anaphylaxis or severe systemic response to any plasma- derived alpha1-PI preparation or other blood product(s). * In the opinion of the investigator, is likely to have compliance problems with the protocol and the procedures of the protocol. * Has any medical condition that the investigator feels might confound the results of the study or pose an additional risk to the subject during study participation.

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Conditions

The condition(s) this trial relates to.

alpha 1-antitrypsin deficiency pulmonary emphysema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary emphysema in alpha-1 antitrypsin deficiency

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Grifols Investigative Site

    Phoenix, Arizona, 85013, United States

  • Grifols Investigative Site

    Miami, Florida, 33136, United States

  • Grifols Investigative Site

    Wilmington, North Carolina, 28401, United States

  • Grifols Investigative Site

    Portland, Oregon, 97239, United States

  • Grifols Investigative Site

    Charleston, South Carolina, 29425, United States

  • Grifols Investigative Site

    Tyler, Texas, 75708, United States

  • Grifols Investigative Site

    Darlinghurst, New South Wales, 2010, Australia

  • Grifols Investigative Site

    Adelaide, 5000, Australia

  • Grifols Investigative Site

    Chermside, 4032, Australia

  • Grifols Investigative Site

    Fitzroy, 3065, Australia

  • Grifols Investigative Site

    Nedlands, 6009, Australia

  • Grifols Investigative Site

    Halifax, B3H 3A7, Canada

  • Grifols Investigative Site

    Toronto, M5T 3A9, Canada

  • Grifols Investigative Site

    Arhus C, 8000, Denmark

  • Grifols Investigative Site

    Hellerup, 2900, Denmark

  • Grifols Investigative Site

    Tallinn, 13419, Estonia

  • Grifols Investigative Site

    Turku, 20520, Finland

  • Grifols Investigative Site

    Bron, Rhone, 69677, France

  • Grifols Investigative Site

    Chisinau, 2025, Moldova

  • Grifols Investigative Site

    Auckland, 2025, New Zealand

  • Grifols Investigative Site

    Christchurch, 8011, New Zealand

  • Grifols Investigative Site

    Hamilton, 3200, New Zealand

  • Grifols Investigative Site

    Krakow, 31-066, Poland

  • Grifols Investigative Site

    Warsaw, 01-138, Poland

  • Grifols Investigative Site

    Barnaul, 656038, Russia

  • Grifols Investigative Site

    Gothenburg, 413 45, Sweden

  • Grifols Investigative Site

    Malmö, 20502, Sweden

  • Grifols Investigative Site

    Stockholm, 11361, Sweden