Pharmacokinetics (PK) and Safety of Subgam®VF in Primary Immunodeficiency Diseases (SCIG03)
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.
Primary Immune Deficiency Disorders
Common Variable Immunodeficiency
Hyperimmunoglobulin M Syndrome
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam®VF in Primary Immunodeficiency Diseases|
- Determine the PK profile of Subgam-VF and compare the Area under the curve to a given treatment period (AUC [0-t)]) with historical data all standardized to 1 week at steady state from Gammaplex 5% IGIV Primary Immune studies (GMX01 and GMX04) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
- Assess the safety of Subgam-VF including the incidence of adverse events (AEs) and site infusion reactions in subjects with primary immunodeficiency [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]Adverse events: Number and percent of infusions associated with 1 or more AEs during the study and specifically AEs that begin during the infusion or within 72 hours after completion of the infusion.
- To explore PK modelling for alternative dosing schedules [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
|Study Start Date:||August 2015|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Subgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion. The total duration of treatment will be for 26 weeks.
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.
Other Name: Subgam-VF
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01884311
|Contact: Sarah Jenkins||+44 20 895 email@example.com|
|United States, California|
|University of California, Irvine||Not yet recruiting|
|Irvine, California, United States, 92697|
|Contact: Sudhir Gupta 949-824-5818|
|Principal Investigator: Sudhir Gupta|
|United States, Colorado|
|Immunoe International Research||Not yet recruiting|
|Centennial, Colorado, United States, 80112|
|Contact: Isaac Melamed 303-773-9000|
|Principal Investigator: Isaac Melamed|
|United States, Florida|
|Allergy Associate of the Palm Beaches||Not yet recruiting|
|North Palm Beach, Florida, United States, 33408|
|Contact: Mark Stein 561-626-4561|
|Principal Investigator: Mark Stein|
|United States, Illinois|
|Rush University Medical Center||Not yet recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: James Moy 312-942-6176|
|Principal Investigator: James Moy|
|United States, North Carolina|
|Duke University||Not yet recruiting|
|Durham, North Carolina, United States, 27710|
|Contact: John Sleasman|
|Principal Investigator: John Sleasman|
|United States, Ohio|
|Optimed Research||Not yet recruiting|
|Columbus, Ohio, United States, 43235|
|Contact: Donald McNeil 614-430-8022|
|Principal Investigator: Donald McNeil|
|United States, Oklahoma|
|Oklahoma Institute of Allergy & Asthma Clinical Research, LLC||Not yet recruiting|
|Oklahoma City, Oklahoma, United States, 73131|
|Contact: Amy Darter 405-607-8159|
|Principal Investigator: Amy Darter|
|United States, Texas|
|AARA Research Center||Not yet recruiting|
|Dallas, Texas, United States, 75231|
|Contact: William Lumry 214-373-7374|
|Principal Investigator: William Lumry|
|Dallas Allergy Immunology||Not yet recruiting|
|Dallas, Texas, United States, 75230|
|Contact: Richard Wasserman 972-566-7788|
|Principal Investigator: Richard Wasserman|
|United States, Virginia|
|O&O Alpan, LLC||Not yet recruiting|
|Fairfax, Virginia, United States, 22030|
|Contact: Oral Alpan 571-308-1900|
|Principal Investigator: Oral Alpan|
|United States, Washington|
|Bellingham Asthma Allergy Clinic||Not yet recruiting|
|Bellingham, Washington, United States, 98225|
|Contact: David Elkayam 360-733-5733|
|Principal Investigator: David Elkayam|
|United States, Wisconsin|
|The Medical College of Wisconsin/Children's Hospital of Wisconsin||Not yet recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: John Routes 414-266-6840|
|Principal Investigator: John Routes|
|Study Director:||Eric Wolford||Bio Products Laboratory Limited|