Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 3, Open-label, Non-controlled, Multi-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Subjects With Primary Immunodeficiency Diseases (PID)

Next Previous
X
Search
Trial Profile

A Phase 3, Open-label, Non-controlled, Multi-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Subjects With Primary Immunodeficiency Diseases (PID)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Immune globulin (Primary) ; Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Pharmacodynamics; Registrational
  • Sponsors Baxalta; Shire; Takeda

    • Most Recent Events

    • 25 Sep 2023 According to Takeda media release, the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU subcutaneous Ig in Japan for patients with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency or secondary immunodeficiency, based on the results of this trail along with results of NCT01218438 and NCT01412385 studies respectively.
    • 23 Feb 2022 Status changed from active, no longer recruiting to completed.
    • 11 May 2021 New trial record

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top