Primary Immunodeficiency Diseases (PIDD)NCT06955793
Expanded Access to TAK-881 for People With Primary Immunodeficiency Diseases in the USA and Czech Republic
A study testing TAK-881 and SC Investigational Needle Sets in people with Primary Immunodeficiency Diseases (PIDD), run by Takeda.
Trial summary
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 [NCT06076642], who continue to derive clinical benefit from maintenance treatment with TAK-881 and… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Primary Immunodeficiency Diseases (PIDD)
- What is being tested?
- TAK-881 and SC Investigational Needle Sets
- Type of treatment
- Injection or infusion, Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002.
- Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician.
- 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).
- Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety.
- Participant does not have a known hypersensitivity to TAK-881 or its components.
Who cannot join
- 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.
- Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expanded Access Program for United States of America: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD); Specific Therapeutic Program for Czech Republic: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD)
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 [NCT06076642], who continue to derive clinical benefit from maintenance treatment with TAK-881 and wish to continue this treatment.
All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.
Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.) and Czech Republic (the device is approved), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.
- Conditions
- Primary Immunodeficiency Diseases (PIDD)
- Being tested
- TAK-881, SC Investigational Needle Sets
- Keywords
- Drug Therapy
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-881Biological
Also called Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)
Participants will receive SC infusion of TAK-881.
SC Investigational Needle SetsDevice
The single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immunodeficiency Diseases (PIDD)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955793
- Sponsor's protocol ID
- TAK-881 EAP
- Other IDs
- TAK-881-3002 PIDD EAP
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program for United States of America: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD); Specific Therapeutic Program for Czech Republic: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD)
- ClinicalTrials.gov ID
- NCT06955793
- Acronym / sponsor ID
- TAK-881 EAP
- Conditions
- Primary Immunodeficiency Diseases (PIDD)
- Keywords
- Drug Therapy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 [NCT06076642], who continue to derive clinical benefit from maintenance treatment with TAK-881 and wish to continue this treatment.
All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.
Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.) and Czech Republic (the device is approved), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.
Study design
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Participant has PIDD and has completed the end-of-study visit of Study TAK-881-3002.
- Participant is demonstrating continued benefit from TAK-881 for the treatment of PIDD in the opinion of the treating physician.
- 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).
- Participant does not have any condition, including laboratory test result, that in the opinion of the treating physician may compromise the participant's safety.
- Participant does not have a known hypersensitivity to TAK-881 or its components.
Key exclusion criteria (2 listed)
- 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.
- Participant is pregnant or lactating or intends to become pregnant or begin lactating during the program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-881Also: Immune Globulin Subcutaneous (Human), 20% Solution with Recombinant Human Hyaluronidase (rHuPH20)Participants will receive SC infusion of TAK-881. | Biological | – |
| SC Investigational Needle SetsThe single-use only SC needle set will be used to administer TAK-881 to the target depth below the skin surface. One needle set (single or bifurcated) will be used per infusion. | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
Questions about this trial
What is this clinical trial studying?
A study testing TAK-881 and SC Investigational Needle Sets in people with Primary Immunodeficiency Diseases (PIDD), run by Takeda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Takeda Contact (+1-877-825-3327, medinfoUS@takeda.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.