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NCT06076642RECRUITINGIRB Ready

A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases

Sponsored by Takeda

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 39 participants interested
3% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The main aim of this study is to learn if TAK-881 is safe and well tolerated during long-term use in adults and children with PIDD who are eligible and completed study TAK-881-3001 (NCT05755035). The participants will receive the first dose of TAK-881 immunoglobulin (IgG) infusion at the same dosage as the last dose administered in study TAK-881-3001 (NCT05755035).

Who Can Participate

Inclusion Criteria

Participants who meet ALL of the following criteria are eligible for this study:
Participant must have completed Study TAK-881-3001 (NCT05755035).
Participant/Participant's parent(s)/legal guardian(s) is/are willing and able to comply with the requirements of the protocol.
Participant/Participant's parent(s)/legal guardian(s) has/have provided informed consent/assent (if applicable), including providing consent for use of the investigational medical device, prior to the initiation of any study procedures.

Exclusion Criteria

Participant has a serious medical condition such that the participant's safety or medical care would be impacted by participation in this long-term follow-up study.
New medical condition that developed during participation in Study TAK-881-3001 (NCT05755035), that, in the judgment of the investigator, could increase risk to the participant or interfere with the evaluation of TAK-881 and/or conduct of the study.
Participant has part

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

39 participants

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Gender

ALL

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Sponsor

Takeda

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Macon

Georgia

Location available
View Macon location page
RECRUITING

Normal

Illinois

Location available
View Normal location page
RECRUITING

The Bronx

New York

Location available
View The Bronx location page
RECRUITING

Durham

North Carolina

Location available
View Durham location page
RECRUITING

Dallas

Texas

Location available
View Dallas location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Primary Immunodeficiency Diseases Treatment in Macon?

Join others in Georgia exploring innovative treatment options through clinical research

Primary Immunodeficiency Diseases Treatment Options in Macon, Georgia

If you're searching for Primary Immunodeficiency Diseases treatment in Macon, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Macon, Normal, The Bronx and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Primary Immunodeficiency Diseases. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Georgia
Now Enrolling
Up to 39 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Primary Immunodeficiency Diseases?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Primary Immunodeficiency Diseases

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Primary Immunodeficiency Diseases Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06076642. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.