NCT03939533

Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases

Clinical Phase 3 Study to Monitor the Safety, Tolerability, and Efficacy of Subcutaneous Human Immunoglobulin (CUTAQUIG®) Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

CLINICAL PHASE 3 STUDY TO MONITOR THE SAFETY, TOLERABILITY, AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (CUTAQUIG®) ADMINISTERED AT MODIFIED DOSING REGIMENS IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES

Conditions

• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
DRUG	CUTAQUIG	Human normal immunoglobulin

Timeline

• Start date: 2019-10-17
• Primary completion: 2022-01-03
• Completion: 2022-01-03
• First posted: 2019-05-06
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study