Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases (SCIG03)
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|ClinicalTrials.gov Identifier: NCT01884311|
Recruitment Status : Completed
First Posted : June 24, 2013
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
|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
- 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. [ Time Frame: 1 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.
- Number of Participants Who Experienced AEs Based on Treatment-emergent AEs (TEAEs) [ Time Frame: 30 weeks ]TEAEs defined as those events with onset date between the first infusion date and 28 days after the last infusion.
- Dose Refinement in Switching From Gammaplex 5% IGIV to Subgam-VF [ Time Frame: Week 26 ]
The initial weekly dose of Subgam-VF administered was calculated by taking the average weekly equivalent of the subject's IGIV dose, divided by the average dosing interval in weeks (i.e. 3 or 4), multiplied by 1.37, a dose adjustment coefficient based on other licensed subcutaneous IgG products. If the subject was already receiving a weekly SCIG IgG there will be no dose adjustment.
A refined dose adjustment was estimated as 1.37/the ratio (Subgam-VF/ Gammaplex 5% IGIV) of geometric means for sAUC0-t and presented with 90% CI.
- Number of Infusion Site Reactions [ Time Frame: 30 weeks ]Infusion site reactions are defined as those events with onset date between the first infusion date and 28 days after the last infusion.
- Population PK Model for IgG in PID Patients for Alternative Dosing Schedules. [ Time Frame: 30 months ]
Develop a population pharmacokinetic (PK) model for IgG in PID patients following IV (Gammaplex 5%) or SC (Subgam-VF) administration;
- Conduct a formal covariate analysis to assess the impact of patient demographics, and disease-related factors on the PK of IgG following IV or SC administration and to identify those patient covariates which may be utilized in or require dose adjustment;
Use the final population PK model to simulate serum IgG concentration-time profiles in a population of PID patients in order to:
- Assess switching from various IgG IV and SC dosing regimens; and
- Derive the weight-adjusted dose increment required to achieve a specified difference in serum IgG trough levels when Subgam-VF is administered either weekly or biweekly
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|