Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases (SCIG03)
|ClinicalTrials.gov Identifier: NCT01884311|
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : August 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Immune Deficiency Disorders Common Variable Immunodeficiency X-linked Agammaglobulinaemia Hyperimmunoglobulin M Syndrome||Biological: Subgam||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases|
|Actual Study Start Date :||August 20, 2015|
|Actual Primary Completion Date :||May 25, 2017|
|Actual Study Completion Date :||May 25, 2017|
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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|