Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases (SCIG03)
|Primary Immune Deficiency Disorders Common Variable Immunodeficiency X-linked Agammaglobulinaemia Hyperimmunoglobulin M Syndrome||Biological: Subgam||Phase 3|
|Study Design:||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 ]
- 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 ]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 ]
|Study Start Date:||August 2015|
|Estimated Study Completion Date:||May 2017|
|Estimated Primary Completion Date:||May 2017 (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
|United States, Arizona|
|Arizona Allergy Associates|
|Chandler, Arizona, United States, 85224|
|United States, California|
|University of California, Irvine|
|Irvine, California, United States, 92697|
|University of California San Diego-- Rady's Children's Hospital|
|San Diego, California, United States, 92123|
|United States, Colorado|
|Immunoe International Research|
|Centennial, Colorado, United States, 80112|
|United States, Florida|
|Allergy Associate of the Palm Beaches|
|North Palm Beach, Florida, United States, 33408|
|United States, Illinois|
|Ann and Robert H Lurie Children's Hospital|
|Chicago, Illinois, United States, 60611|
|United States, Minnesota|
|Cardinal Glennon Children's Medical Center|
|Minneapolis, Minnesota, United States, 63104|
|United States, Ohio|
|Columbus, Ohio, United States, 43235|
|United States, Oklahoma|
|Oklahoma Institute of Allergy & Asthma Clinical Research, LLC|
|Oklahoma City, Oklahoma, United States, 73131|
|United States, Pennsylvania|
|Pennsylvania State University|
|Hershey, Pennsylvania, United States, 174033|
|United States, Texas|
|Dallas Allergy Immunology|
|Dallas, Texas, United States, 75230|
|AARA Research Center|
|Dallas, Texas, United States, 75231|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84112|
|United States, Virginia|
|O&O Alpan, LLC|
|Fairfax, Virginia, United States, 22030|
|United States, Washington|
|Bellingham Asthma Allergy Clinic|
|Bellingham, Washington, United States, 98225|
|United States, Wisconsin|
|The Medical College of Wisconsin/Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Study Director:||Eric Wolford||Bio Products Laboratory Limited|