TAK-881 / Takeda - LARVOL DELTA

A Study of TAK-881 and HyQvia in Healthy Adults (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open

TAK-881-1003: A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open

Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USA (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: Takeda

New trial • Immunology • Primary Immunodeficiency

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P2/3 | N=65 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Adverse events • Enrollment closed • Immunology • Primary Immunodeficiency

A Study of TAK-881 With and Without Ramp-Up Dosing in Healthy Adults (clinicaltrials.gov) - P1 | N=64 | Not yet recruiting | Sponsor: Takeda

New P1 trial

A Study of TAK-881 and HyQvia in Healthy Adults (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Takeda

New P1 trial

A Study to Compare TAK-881 and HYQVIA in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) (clinicaltrials.gov) - P3 | N=59 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Pain

A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P3 | N=39 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Primary Immunodeficiency

A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P3 | N=39 | Not yet recruiting | Sponsor: Takeda | Trial completion date: May 2027 ➔ Jan 2029 | Trial primary completion date: May 2027 ➔ Jan 2029

Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency

A Study of TAK-881 in Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Takeda | N=80 ➔ 24

Enrollment change

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P2/3 | N=71 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Immunology • Primary Immunodeficiency

A Study About the Long-Term Safety of TAK-881 in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P3 | N=39 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Immunology • Primary Immunodeficiency

A Study About How TAK-881 is Processed by the Body and Side Effects in People With Primary Immunodeficiency Diseases (clinicaltrials.gov) - P2/3 | N=71 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Apr 2025 ➔ Sep 2026 | Trial primary completion date: Apr 2025 ➔ Feb 2026

Adverse events • Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency

A Study of TAK-881 in Participants With Primary Immunodeficiency Diseases (PIDD) (clinicaltrials.gov) - P2/3 | N=61 | Not yet recruiting | Sponsor: Takeda | Initiation date: Mar 2023 ➔ Oct 2023

Trial initiation date • Immunology • Primary Immunodeficiency

In-line warming reduces in-line pressure of subcutaneous infusion of concentrated immunoglobulins. (PubMed, Drug Deliv Transl Res) - "Subcutaneous infusion studies in pigs confirmed the feasibility of infusion rates of up to 7.5 mL/min with in-line warmed TAK-881, an immunoglobulin 20% facilitated with recombinant human hyaluronidase...In summary, an in in-line warming device can circumvent the limitation of high viscosity, while product quality and local tolerance are maintained. The results of the presented studies warrant further testing in a phase 1 clinical study."

Journal • Immunology

A Study of TAK-881 in Participants With Primary Immunodeficiency Diseases (PIDD) (clinicaltrials.gov) - P2/3 | N=61 | Not yet recruiting | Sponsor: Takeda

New P2/3 trial • Immunology • Primary Immunodeficiency

A Study of TAK-881 in Healthy Adults (clinicaltrials.gov) - P1 | N=80 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion

A Study of TAK-881 in Healthy Adults (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting | N=24 ➔ 80

Enrollment change • Enrollment closed

A Study of TAK-881 in Healthy Adults (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Takeda; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open