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Compassionate access program offers continued treatment for immune deficiency

NCT ID NCT06955793

Disease control Sponsor: Takeda 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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This expanded access program provides TAK-881, a subcutaneous immunoglobulin treatment, to people with primary immunodeficiency diseases (PIDD) who completed a prior study and continue to benefit from the therapy. Participants receive regular infusions under the skin using a special needle set. The program aims to maintain access until the treatment becomes commercially available or the participant no longer benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-881 (immune globulin subcutaneous with recombinant human hyaluronidase)
What this could lead to
If successful, this program offers continued access to a potentially effective treatment for people with primary immunodeficiency diseases.
What could go wrong
This is an expanded access program, not a controlled trial, so results are observational and may not prove safety or effectiveness broadly. Individual responses may vary.

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.

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

2 years and older

Sex

Anyone

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: 1. Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002. 2. Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician. 3. Participant, or (in the case of minors) legally designated representative(s) is/are informed of the nature of this program and can provide written informed consent/assent (if applicable). 4. Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety. 5. Participant does not have a known hypersensitivity to TAK-881 or its components. Exclusion Criteria: 1. Participant has potential to become pregnant and the participant does not agree to employ a highly effective form of contraception for the duration of the program. 2. Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.

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Conditions

The condition(s) this trial relates to.

inborn error of immunity Primary Immunodeficiency Diseases

As listed by the trial registrant

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

Primary immunodeficiency diseases (PIDD)

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

Study contacts

  • Contact

    Email: •••••@•••••