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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01884311
• Date of registration: 14/06/2013
• Prospective Registration: Yes
• Primary sponsor: Bio Products Laboratory
• Public title: Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases SCIG03
• Scientific title: A Phase III, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Subgam-VF in Primary Immunodeficiency Diseases
• Date of first enrolment: August 20, 2015
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01884311
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Eric Wolford
• Affiliation: Bio Products Laboratory Limited

Key inclusion & exclusion criteria

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.



Age minimum: 2 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Common Variable Immunodeficiency

Hyperimmunoglobulin M Syndrome

Primary Immune Deficiency Disorders

X-linked Agammaglobulinaemia

Intervention(s)

Biological: Subgam

Primary Outcome(s)

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]

Secondary Outcome(s)

Number of Infusion Site Reactions [Time Frame: 30 weeks]

Number of Participants Who Experienced AEs Based on Treatment-emergent AEs (TEAEs) [Time Frame: 30 weeks]

Dose Refinement in Switching From Gammaplex 5% IGIV to Subgam-VF [Time Frame: Week 26]

Secondary ID(s)

SCIG03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/09/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01884311