Common Variable Immunodeficiency Clinical Trial
— SCIG03Official title:
A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases
NCT number | NCT01884311 |
Other study ID # | SCIG03 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | August 20, 2015 |
Est. completion date | May 25, 2017 |
Verified date | August 2018 |
Source | Bio Products Laboratory |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 25, 2017 |
Est. primary completion date | May 25, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 75 Years |
Eligibility |
Inclusion criteria: 1. Aged between 2 and 75 years (at time of initial consent). 2. Body Mass Index (BMI) < 46 for adults (aged 16 years & older), & BMI < 28 for children. 3. Diagnosed with primary immunodeficiency disease e.g. common variable immunodeficiency, X-linked & autosomal forms of agammaglobulinaemia, hyper-IgM syndrome, Wiskott-Aldrich syndrome. 4. Currently receiving a licensed (or investigational stage III, IIIb) IGIV or SCIG and 1. IGIV dose is between 300 and 800 mg/kg/month. SCIG dose is between 110 & 300 mg/kg/week; 2. Dose is stable for at least the past three months (i.e. consistent mg/kg +/- 5%); 3. The infusion interval is every 21 or 28 days for IGIV & seven days for SCIG; 4. 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). 5. Female subjects who are (or become) sexually active must practice contraception by using a method of proven reliability for the duration of the study. 6. 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. 7. Willing to comply with all aspects of the protocol, including blood sampling, for the duration of the study. 8. 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. Exclusion Criteria: 1. Has a history of any severe anaphylactic reaction to blood or any blood-derived product. 2. Has selective IgA deficiency or has a history of antibodies to IgA. 3. Has clinically significant impairment of cellular or innate immunity at the discretion of the Investigator 4. 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. 5. Has previously completed or withdrawn from this study. 6. 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. 7. Is pregnant (confirmed by a positive result on an HCG-based pregnancy test) or is nursing. 8. Is positive for any of the following at screening: • Serological test for HIV 1&2, HCV, or HBsAg 9. 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) 10. 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. 11. Is known to abuse alcohol, opiates, psychotropic agents, or other chemicals or drugs, or has done so within the past 12 months. 12. Has a history of DVT, or thrombotic complications of IgG therapy, or a prior diagnosis of thrombophilia. 13. Suffers from any acute or chronic medical condition, (e.g. renal disease or predisposing conditions for renal disease, coronary artery disease, or protein losing state, proteinuria) that the Investigator feels may interfere with the conduct of the study. 14. Has an acquired medical condition, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (ANC < 1 x 109/L). 15. Is receiving the following medication: - Steroids (long-term daily, > 0.15 mg of prednisone equivalent/kg/day). Requirement for short or intermittent courses of > 0.15mg/kg/day would not exclude a subject. - Immunosuppressive drugs - Immunomodulatory drugs 16. If = 18 years of age, has non-controlled arterial hypertension (systolic blood pressure > 160 mmHg &/or diastolic blood pressure > 100 mmHg). For younger subjects refer to current guidelines for diagnosis of blood pressure1. 17. Has anemia (hemoglobin < 10 g/dL) at screening. 18. Has severe dermatitis that would preclude sites for safe product administration. |
Country | Name | City | State |
---|---|---|---|
United States | Bellingham Asthma Allergy Clinic | Bellingham | Washington |
United States | Immunoe International Research | Centennial | Colorado |
United States | Arizona Allergy Associates | Chandler | Arizona |
United States | Ann and Robert H Lurie Children's Hospital | Chicago | Illinois |
United States | Optimed Research | Columbus | Ohio |
United States | AARA Research Center | Dallas | Texas |
United States | Dallas Allergy Immunology | Dallas | Texas |
United States | O&O Alpan, LLC | Fairfax | Virginia |
United States | Pennsylvania State University | Hershey | Pennsylvania |
United States | University of California, Irvine | Irvine | California |
United States | The Medical College of Wisconsin/Children's Hospital of Wisconsin | Milwaukee | Wisconsin |
United States | Cardinal Glennon Children's Medical Center | Minneapolis | Minnesota |
United States | Allergy Associate of the Palm Beaches | North Palm Beach | Florida |
United States | Oklahoma Institute of Allergy & Asthma Clinical Research, LLC | Oklahoma City | Oklahoma |
United States | University of Utah | Salt Lake City | Utah |
United States | University of California San Diego-- Rady's Children's Hospital | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Bio Products Laboratory |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Population PK Model for IgG in PID Patients for Alternative Dosing Schedules. | 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 |
30 months | |
Primary | 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 | Number of Participants Who Experienced AEs Based on Treatment-emergent AEs (TEAEs) | TEAEs defined as those events with onset date between the first infusion date and 28 days after the last infusion. | 30 weeks | |
Secondary | Dose Refinement in Switching From Gammaplex 5% IGIV to Subgam-VF | 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. |
Week 26 | |
Secondary | Number of Infusion Site Reactions | Infusion site reactions are defined as those events with onset date between the first infusion date and 28 days after the last infusion. | 30 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03663933 -
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation
|
Phase 2 | |
Recruiting |
NCT01652092 -
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
|
N/A | |
Recruiting |
NCT05321407 -
COVID-19 Vaccine Responses in PIDD Subjects
|
||
Recruiting |
NCT04339777 -
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity
|
Phase 2 | |
Completed |
NCT00542997 -
Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy
|
Phase 3 | |
Completed |
NCT00168025 -
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
|
Phase 3 | |
Completed |
NCT00168012 -
Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
|
Phase 3 | |
Completed |
NCT00004695 -
Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency
|
N/A | |
Completed |
NCT01196702 -
Lymphocyte Immunophenotyping in Common Variable Immunodeficiency
|
||
Recruiting |
NCT06355323 -
Bronchiectasis Prevalence in Patients With Primary Humoral Immunodefiency in Champagne-Ardenne Region, France
|
N/A | |
Completed |
NCT00322556 -
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
|
Phase 3 | |
Recruiting |
NCT02579967 -
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
|
Phase 2 | |
Recruiting |
NCT06145100 -
Prediction of Portal Hypertension in Patients With CVID (CVID-pHT)
|
||
Completed |
NCT01289847 -
A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency
|
Phase 4 | |
Completed |
NCT00520494 -
Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
|
Phase 4 | |
Terminated |
NCT00006054 -
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
|
N/A | |
Completed |
NCT03211689 -
The Impact of Exercise on Stress, Fatigue, and Quality of Life in Individuals With Primary Immunodeficiency Disease
|
N/A | |
Terminated |
NCT01489618 -
"Prime Boost" Vaccination Strategy Combining Conjugated Anti- Pneumococcal Vaccine (s0) and Polysaccharide Anti- Pneumococcal Vaccine (s4) Compared to Polysaccharide Anti- Pneumococcal Vaccine Alone (s4) In Patients With Common Variable Immunodeficiency
|
Phase 2 | |
Completed |
NCT03513328 -
Conditioning Regimen for Allogeneic Hematopoietic Stem-Cell Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT03188419 -
Breadth of Donor Options for People With Inherited Diseases Requiring Allogeneic Hematopoietic Stem Cell Transplant in the Era of Alternative Donor Transplants Using Post-Transplantation Cyclophosphamide
|