NCT01884311

Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases

A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Bio Products Laboratory · Academic / Other
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.

Detailed description

This will be a Phase III, multicenter, open-label, non-randomized study. Following a screening period, eligible subjects will commence weekly Subgam-VF treatment; this is a 16% subcutaneous IgG product. Subjects will receive Subgam-VF for 26 weeks during which time safety will be assessed. After Week 21, PK sampling will commence. Follow-up visit (one week after the last Subgam-VF infusion, Week 27). All AEs will be monitored up to 28 days after the last Subgam-VF infusion by telephone contact (Week 30). Subgam-VF will be administered subcutaneously using infusion pumps. Subjects will be given diaries to record adverse event data as well as any infusions administered at home. In addition there will be a telephone follow up by an appropriately qualified site staff member on day 3 after each site administered and home administered infusion to check for any adverse reactions including infusion site reactions and remind subjects to document these in their subject study diary.

Conditions

• Primary Immune Deficiency Disorders
• Common Variable Immunodeficiency
• X-linked Agammaglobulinaemia
• Hyperimmunoglobulin M Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Subgam	Subgam-VF dose will be given as 1.37 of the established IGIV dose (expressed in mg/kg/week) for 26 weeks (26 infusions) beginning one week after the last IGIV infusion. Dose of Subgam-VF will then be adjusted based on the ratio of the Immunoglobulin G (IgG) average concentration achieved with Subgam-VF compared to IGIV.

Timeline

• Start date: 2015-08-20
• Primary completion: 2017-05-25
• Completion: 2017-05-25
• First posted: 2013-06-24
• Last updated: 2018-09-12
• Results posted: 2018-09-12

Locations

16 sites across 1 country: United States