Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases



Status:Completed
Conditions:Other Indications, Infectious Disease, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:2 - 75
Updated:9/14/2018
Start Date:August 20, 2015
End Date:May 25, 2017

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A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases

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.

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.

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.
We found this trial at
16
sites
Minneapolis, Minnesota 63104
Principal Investigator: Alan Knutsen
Phone: 314-977-5301
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
Principal Investigator: Karin Chen
Phone: 801-587-7576
University of Utah Research is a major component in the life of the U benefiting...
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Bellingham, Washington 98225
Principal Investigator: David Elkayam
Phone: 360-733-5733
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Centennial, Colorado 80112
Principal Investigator: Isaac Melamed
Phone: 303-773-9000
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Chandler, Arizona 85224
Principal Investigator: Duane Wong
Phone: 480-897-6992
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Chicago, Illinois 60614
Principal Investigator: Melanie Makhija
Phone: 314-737-6411
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Columbus, Ohio 43235
Principal Investigator: Donald McNeil
Phone: 614-430-8022
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Dallas, Texas 75230
Principal Investigator: Richard Wasserman
Phone: 972-566-7788
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Dallas, Texas 75231
Principal Investigator: William Lumry
Phone: 214-373-7374
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Fairfax, Virginia 22031
Principal Investigator: Oral Alpan
Phone: 571-308-1900
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Hershey, Pennsylvania 17033
Principal Investigator: Timothy Craig
Phone: 717-531-6525
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Irvine, California 92697
949-824-5011
Principal Investigator: Sudhir Gupta
Phone: 949-824-5818
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Milwaukee, Wisconsin 53226
Principal Investigator: John Routes
Phone: 414-266-6840
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North Palm Beach, Florida 33408
Principal Investigator: Mark Stein
Phone: 561-626-4561
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Oklahoma City, Oklahoma 73131
Principal Investigator: Amy Darter
Phone: 405-607-8159
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San Diego, California
Principal Investigator: Bob Geng
Phone: 314-608-8693
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