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Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL

Trial Profile

Title for SCGAM-03: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES WHO HAVE COMPLETED THE SCGAM-01 TRIAL Title for SCGAM-03 in Canada: CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Dec 2022

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Primary immunodeficiency diseases
  • Focus Adverse reactions; Registrational
  • Sponsors Octapharma

Most Recent Events

  • 15 Dec 2022 Results of two studies (SCGAM-01 & SCGAM-03) assessing efficacy, safety, and tolerability of a subcutaneous immunoglobulin 16.5% in the treatment of patients with primary immunodeficiencies, published in the Clinical and Experimental Immunology.
  • 01 Mar 2021 Results presented at the 2021 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
  • 01 Sep 2020 Eligibility criteria amended to include subjects 2 to 75 Years of age. Time frame changed from Through study completion, about 12 months to From study start to end, up to 3.5 years.

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