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Hyaluronidase (Human Recombinant)

Clinical trials of Hyaluronidase (Human Recombinant) are studying subcutaneous treatment approaches in people with primary immunodeficiency diseases and chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). These trials mainly look at safety, tolerability, and how the treatment behaves in the body, including pharmacokinetics. The studies include adults and older adolescents in different trial phases.

Table of Contents

Overview of the trial program

The clinical trial data for Hyaluronidase (Human Recombinant) focus on studies of subcutaneous treatment, which means treatment given under the skin.[1] The main trial settings in the source data are primary immunodeficiency diseases and chronic inflammatory demyelinating polyradiculoneuropathy, also called CIDP.[1][2][3]

Most of the listed studies are designed to compare TAK-881 with HyQvia, and they look at how the treatment behaves in the body, as well as safety and tolerability.[2][3] One additional Phase 1 trial in the source data is about subcutaneous durvalumab and is not a Hyaluronidase (Human Recombinant) study.[4]

Trials in primary immunodeficiency diseases

Two trials in the source data are for people with Primary Immunodeficiency Diseases (PIDD), a group of conditions where the immune system does not work properly.[1][2] These studies include a Phase 3 long-term safety study and a Phase 4 crossover study that compares treatments in older adolescents and adults.[1][2]

NCT06076642 is a Phase 3 study with 37 enrolled participants and the status listed as Authorised.[1] Its goal is to evaluate long-term safety and tolerability of TAK-881, with primary outcomes that include treatment-emergent adverse events and infusion withdrawals, interruptions, and rate reductions linked to TAK-881-related adverse events.[1]

NCT05755035 is a multicenter, prospective, open-label, randomized, crossover Phase 4 study with 50 enrolled participants and a Completed status.[2] It aims to show pharmacokinetic comparability between TAK-881 and HyQvia at steady-state after subcutaneous administration in subjects aged 16 years and older with PIDD.[2]

In simple terms, this means the researchers are checking whether the two treatments give similar blood exposure over time in the study group.[2] The main endpoint is AUC0-τ,ss based on total IgG levels, which is a way to measure total exposure during a dosing interval at steady-state.[2]

Trials in CIDP

One Phase 3 study in the source data targets adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP), a long-lasting nerve disorder that can affect strength and movement.[3] This study is listed as Authorised and includes 65 participants.[3]

The study is a single-arm, multiple-dose, pharmacokinetic comparability trial between TAK-881 and HyQvia in adults with CIDP.[3] Its brief summary says the purpose is to show pharmacokinetic comparability after subcutaneous administration in participants with CIDP.[3]

The primary outcome is baseline-uncorrected area under the curve during the dosing interval at steady-state, based on total IgG levels.[3] This tells researchers how much treatment exposure the body has over the dosing period.[3]

What the trials measure

The listed trials measure both safety and pharmacokinetics (PK), which means how the treatment moves through the body.[1][2][3]

  • Treatment-emergent adverse events (TEAEs): unwanted medical events that happen after treatment starts.[1]

  • Infusion withdrawals, interruptions, and rate reductions: these show whether the infusion had to be stopped, paused, or slowed because of treatment-related problems.[1]

  • AUC0-τ,ss: a measure of total drug exposure over one dosing interval at steady-state.[2][3]

  • Total IgG levels: the studies use this blood marker to compare exposure between treatments.[2][3]

Study design and phases

The source data includes Phase 3, Phase 4, and Phase 1 studies, but only the Phase 3 and Phase 4 studies are directly about Hyaluronidase (Human Recombinant) in the provided records.[1][2][3][4]

The PIDD Phase 4 study is described as multicenter, prospective, open-label, randomized, and crossover.[2] These words mean the study was done at more than one center, followed participants forward in time, did not hide the assigned treatment, randomly assigned treatment order, and had participants receive more than one study treatment in sequence.[2]

The CIDP study is single-arm and multiple-dose, which means there is no separate comparison group in the source description and participants receive more than one dose during the study.[3]

What patients should know from the trial data

From the available trial records, Hyaluronidase (Human Recombinant) research is centered on people with immune-related and nerve-related conditions, especially PIDD and CIDP.[1][2][3]

The main research questions are whether the study treatments are safe, whether they are tolerated over time, and whether they produce similar exposure in the body when compared with HyQvia.[1][2][3]

The source data does not give detailed results, so the article can only describe the study goals, populations, phases, and outcomes that were planned or measured.[1][2][3]

Trial ID Phase Condition studied Status Enrollment
NCT06076642 Phase 3 Primary Immunodeficiency Diseases Authorised 37
NCT05755035 Phase 4 Primary Immunodeficiency Diseases Completed 50
2024-517450-95-00 Phase 3 Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) Authorised 65

FAQ

  • What are clinical trials of Hyaluronidase (Human Recombinant) studying? The trials are mainly studying safety, tolerability, and pharmacokinetics, which means how the treatment moves through the body. They also compare it with HyQvia in people with primary immunodeficiency diseases and CIDP.
  • Who can take part in these trials? The target groups include people with primary immunodeficiency diseases and adults with chronic inflammatory demyelinating polyradiculoneuropathy. One study includes participants aged 16 years and older.
  • What trial phases are listed? The trials include Phase 1, Phase 3, and Phase 4 studies. This shows that the research includes early testing, larger safety studies, and later comparison studies.
  • What conditions are being studied? The main conditions are primary immunodeficiency diseases and chronic inflammatory demyelinating polyradiculoneuropathy, also called CIDP. One listed trial for subcutaneous durvalumab is not about Hyaluronidase (Human Recombinant).
  • What outcomes are measured in these studies? The studies measure outcomes such as treatment-emergent adverse events, infusion withdrawals, infusion interruptions, infusion rate reductions, and area under the curve. Area under the curve is a way to measure total drug exposure over time.

Ongoing Clinical Trials on Hyaluronidase (Human Recombinant)

  • A study to investigate the safety and effects of ceralasertib, tremelimumab, and durvalumab in adults with various solid tumors

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Comparison of TAK-881 and HyQvia for adults with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

    Recruiting

    1 1 1 1
    Investigated drugs:
    Czechia Denmark Germany Greece Italy Poland +2

  • Study on Long-term Safety of TAK-881 (Human Normal Immunoglobulin, Hyaluronidase) for Patients with Primary Immunodeficiency Diseases

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Germany Greece The Netherlands Poland +2

  • Study on the Effects of TAK-881 and Hyaluronidase in Adults with Primary Immunodeficiency Diseases

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Germany Greece The Netherlands Poland +2

Glossary

  • Primary Immunodeficiency Diseases (PIDD): A group of conditions where the immune system does not work properly and may not fight infections well.
  • Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): A long-lasting nerve disorder that can cause weakness, numbness, and trouble with movement.
  • Phase 1: An early trial phase that usually focuses on safety and how the treatment behaves in the body.
  • Phase 3: A later trial phase that often includes more people and checks safety and effectiveness in a larger group.
  • Phase 4: A study phase done after a treatment is already in use, often to learn more about safety and performance.
  • Pharmacokinetics (PK): How a treatment is absorbed, moved, and removed by the body.
  • Steady-state: A point when the amount of treatment in the body stays fairly stable with repeated dosing.
  • AUC0-τ,ss: A measure of total drug exposure during one dosing interval at steady-state.
  • Total IgG: The total amount of a type of antibody measured in the blood.
  • TEAEs: Treatment-emergent adverse events, meaning unwanted medical events that happen during the study after treatment starts.
  • Infusion withdrawal: Stopping an infusion before it is finished.
  • Open-label: A study where both the researchers and participants know which treatment is being given.

References