Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases
SCIG03
A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases
1 other identifier
interventional
38
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2015
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2013
CompletedFirst Posted
Study publicly available on registry
June 24, 2013
CompletedStudy Start
First participant enrolled
August 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2017
CompletedResults Posted
Study results publicly available
September 12, 2018
CompletedSeptember 12, 2018
August 1, 2018
1.8 years
June 14, 2013
February 28, 2018
August 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Data (Derived From Absolute Concentration) Were Pooled With Historical Data and a Treatment Variable Defined (Subgam-VF or Gammaplex 5% IGIV). Outcome Measure Defined as Log Transformed sAUC0-t Standardized to One Week.
Log transformed sAUC0-t, (AUC0-t standardized to one week) were analysed using a multiple linear regression model fitted including treatment, allowing for variability between treatment groups. The mean difference (Subgam-VF or Gammaplex IGIV 5%) between treatments with 90% Confidence Interval (CI) were back transformed to give an estimate of the ratio (Subgam-VF/ Gammaplex 5% IGIV) of sAUC(0-t). Data was collected at the following timepoints after week 21 of the clinical trial over a period of 1 week: Pre-dose on Day 0 and post-dose at days 1, 2, 3, 5 and 7.
1 week
Secondary Outcomes (3)
Number of Participants Who Experienced AEs Based on Treatment-emergent AEs (TEAEs)
30 weeks
Dose Refinement in Switching From Gammaplex 5% IGIV to Subgam-VF
Week 26
Number of Infusion Site Reactions
30 weeks
Other Outcomes (1)
Population PK Model for IgG in PID Patients for Alternative Dosing Schedules.
30 months
Study Arms (1)
Subgam-VF
EXPERIMENTALSubgam-VF is a 16% IgG and will be administered weekly, by subcutaneous infusion. The total duration of treatment will be for 26 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Aged between 2 and 75 years (at time of initial consent).
- Body Mass Index (BMI) \< 46 for adults (aged 16 years \& older), \& BMI \< 28 for children.
- Diagnosed with primary immunodeficiency disease e.g. common variable immunodeficiency, X-linked \& autosomal forms of agammaglobulinaemia, hyper-IgM syndrome, Wiskott-Aldrich syndrome.
- Currently receiving a licensed (or investigational stage III, IIIb) IGIV or SCIG and
- IGIV dose is between 300 and 800 mg/kg/month. SCIG dose is between 110 \& 300 mg/kg/week;
- Dose is stable for at least the past three months (i.e. consistent mg/kg +/- 5%);
- The infusion interval is every 21 or 28 days for IGIV \& seven days for SCIG;
- Has a documented trough level of ≥ 6 g/L (600 mg/dL) on current IgG therapy. If not available can be obtained at the screening visit, Visit 1 (Week 0).
- Female subjects who are (or become) sexually active must practice contraception by using a method of proven reliability for the duration of the study.
- Females of child-bearing potential, (defined from the onset of menstruation to one year post menopause), must have a negative result on a urine HCG-based pregnancy test.
- Willing to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
- Signed an informed consent form. In the case of subjects under the legal age the parent/guardian will sign an informed consent form \& where appropriate the subject will sign an assent form.
You may not qualify if:
- Has a history of any severe anaphylactic reaction to blood or any blood-derived product.
- Has selective IgA deficiency or has a history of antibodies to IgA.
- Has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator
- Has evidence of an active infection at the time of enrolment (i.e. on day of first infusion). Subjects who are asymptomatic but have not completed their course of antibiotics are eligible.
- Has previously completed or withdrawn from this study.
- Is currently receiving, or has received, any investigational agent within the prior three months, unless it is an investigational stage III, IIIb IGIV or SCIG.
- Is pregnant (confirmed by a positive result on an HCG-based pregnancy test) or is nursing.
- Is positive for any of the following at screening:
- Serological test for HIV 1\&2, HCV, or HBsAg
- Has levels at screening greater than 2.5 times the upper limit of normal as defined at the central laboratory of any of the following:
- Alanine transaminase (ALT)
- Aspartate transaminase (AST)
- Has severe renal impairment (defined as serum creatinine greater than two times the upper limit of normal or BUN greater than two times the upper limit of normal for the range of the laboratory doing the analysis); the subject is on dialysis; or has a history of acute renal failure.
- Is known to abuse alcohol, opiates, psychotropic agents, or other chemicals or drugs, or has done so within the past 12 months.
- Has a history of DVT, or thrombotic complications of IgG therapy, or a prior diagnosis of thrombophilia.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Arizona Allergy Associates
Chandler, Arizona, 85224, United States
University of California, Irvine
Irvine, California, 92697, United States
University of California San Diego-- Rady's Children's Hospital
San Diego, California, 92123, United States
Immunoe International Research
Centennial, Colorado, 80112, United States
Allergy Associate of the Palm Beaches
North Palm Beach, Florida, 33408, United States
Ann and Robert H Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Cardinal Glennon Children's Medical Center
Minneapolis, Minnesota, 63104, United States
Optimed Research
Columbus, Ohio, 43235, United States
Oklahoma Institute of Allergy & Asthma Clinical Research, LLC
Oklahoma City, Oklahoma, 73131, United States
Pennsylvania State University
Hershey, Pennsylvania, 174033, United States
Dallas Allergy Immunology
Dallas, Texas, 75230, United States
AARA Research Center
Dallas, Texas, 75231, United States
University of Utah
Salt Lake City, Utah, 84112, United States
O&O Alpan, LLC
Fairfax, Virginia, 22030, United States
Bellingham Asthma Allergy Clinic
Bellingham, Washington, 98225, United States
The Medical College of Wisconsin/Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- European Medical Affairs Lead
- Organization
- Bio Products Laboratory Ltd
Study Officials
- STUDY DIRECTOR
Eric Wolford
Bio Products Laboratory Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2013
First Posted
June 24, 2013
Study Start
August 20, 2015
Primary Completion
May 25, 2017
Study Completion
May 25, 2017
Last Updated
September 12, 2018
Results First Posted
September 12, 2018
Record last verified: 2018-08