NCT01884311 (SCIG03) is a Phase 3 clinical trial of Subgam in Primary Immune Deficiency Disorders, sponsored by Bio Products Laboratory.

Who is sponsoring NCT01884311?

NCT01884311 is sponsored by Bio Products Laboratory.

What drugs are being tested in NCT01884311?

Interventions in NCT01884311: Subgam.

What condition does NCT01884311 study?

NCT01884311 studies Primary Immune Deficiency Disorders, Common Variable Immunodeficiency, X-linked Agammaglobulinaemia, Hyperimmunoglobulin M Syndrome.

Is NCT01884311 still recruiting?

NCT01884311 is currently completed. Last updated 12 September 2018.

Are results published for NCT01884311?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-09-12 · How we verify

NCT01884311: SCIG03

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 12 September 2018

What this trial tests

Phase 3 trial testing Subgam in Primary Immune Deficiency Disorders in 38 participants. Completed in 25 May 2017.

Timeline

20 August 2015

Primary endpoint
25 May 2017

25 May 2017

Quick facts

Lead sponsor	Bio Products Laboratory
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	38
Start date	20 August 2015
Primary completion	25 May 2017
Estimated completion	25 May 2017
Sites	16 locations across United States

Drugs / interventions tested

Subgam — full drug profile →

Conditions studied

Primary Immune Deficiency Disorders — all drugs for Primary Immune Deficiency Disorders →
Common Variable Immunodeficiency — all drugs for Common Variable Immunodeficiency →
X-linked Agammaglobulinaemia — all drugs for X-linked Agammaglobulinaemia →
Hyperimmunoglobulin M Syndrome — all drugs for Hyperimmunoglobulin M Syndrome →

Sponsor

Bio Products Laboratory — full company profile →

Who can join

Adults 2 to 75, any sex, with Primary Immune Deficiency Disorders or Common Variable Immunodeficiency. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 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.

Group	Value	95% CI
Subgam-VF and Gammaplex 5%	0.98	0.91 – 1.05

Number of Participants Who Experienced AEs Based on Treatment-emergent AEs (TEAEs) Secondary · 30 weeks

TEAEs defined as those events with onset date between the first infusion date and 28 days after the last infusion.

Any TEAE

Group	Value	95% CI
Subgam-VF	36

No TEAE

Group	Value	95% CI
Subgam-VF	2

Discontinued because of TEAEs

Group	Value	95% CI
Subgam-VF	1

Product Related TEAE

Group	Value	95% CI
Subgam-VF	15

No Product Related TEAEs

Group	Value	95% CI
Subgam-VF	23

SAE

Group	Value	95% CI
Subgam-VF	0

Dose Refinement in Switching From Gammaplex 5% IGIV to Subgam-VF Secondary · 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.

Group	Value	95% CI
Subgam-VF and Gammaplex 5%	1.33	1.23 – 1.44

Number of Infusion Site Reactions Secondary · 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.

Group	Value	95% CI
Subgam-VF	447

Population PK Model for IgG in PID Patients for Alternative Dosing Schedules. Secondary · 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 * Der

Increase from IGIV to Weekly Subgam

Group	Value	95% CI
Subgam-VF	31

Increase from IGIV to Biweekly Subgam

Group	Value	95% CI
Subgam-VF	22

Decrease from Weekly Subgam to Biweekly Subgam

Group	Value	95% CI
Subgam-VF	7

Increase from Weekly Subgam to twice weekly Subgam

Group	Value	95% CI
Subgam-VF	2

Increase from Weekly Subgam to 3x weekly Subgam

Group	Value	95% CI
Subgam-VF	3

Increase from weekly Subgam to 5x weekly Subgam

Group	Value	95% CI
Subgam-VF	3

Increase from weekly Subgam to 7x weekly Subgam

Group	Value	95% CI
Subgam-VF	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 7 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Subgam-VF

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (40 terms — click to expand)

Reaction	System	Subgam-VF
Nasopharyngitis	Infections and infestations	—
Diarrhoea	Gastrointestinal disorders	—
Headache	Nervous system disorders	—
Infusion Site Erythema	General disorders	—
Infusion Site Pain	General disorders	—
Pyrexia	General disorders	—
Viral Upper Respiratory Tract Infection	Infections and infestations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Infusion Site Pruritus	General disorders	—
Acute Sinusitis	Infections and infestations	—
Sinusitis	Infections and infestations	—
Urinary Tract Infection	Infections and infestations	—
Coombs Direct Test Positive	Investigations	—
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	—
Fatigue	General disorders	—
Pain	General disorders	—
Bronchitis	Infections and infestations	—
Gastroenteritis Viral	Infections and infestations	—
Pharyngitis Streptococcal	Infections and infestations	—
Upper Respiratory Tract Infection	Infections and infestations	—
Pain in Extremity	Musculoskeletal and connective tissue disorders	—
Haemosiderinuria	Renal and urinary disorders	—
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	—
Dermatitis Contact	Skin and subcutaneous tissue disorders	—
Abdominal Pain	Gastrointestinal disorders	—
Abdominal Pain Upper	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Chest Pain	General disorders	—
Infusion Site Bruising	General disorders	—
Infusion Site Swelling	General disorders	—
Gastroenteritis	Infections and infestations	—
Rhinitis	Infections and infestations	—
Ligament Sprain	Injury, poisoning and procedural complications	—
Tooth Fracture	Injury, poisoning and procedural complications	—
Back Pain	Musculoskeletal and connective tissue disorders	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—
Tendonitis	Musculoskeletal and connective tissue disorders	—
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Rash	Skin and subcutaneous tissue disorders	—
Tooth Extraction	Surgical and medical procedures	—

Data from ClinicalTrials.gov NCT01884311 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Primary Immune Deficiency Disorders

Currently open trials in the same condition.

NCT04414046 — TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic D · Phase 2 · recruiting

Other Bio Products Laboratory trials

Trials by the same sponsor.

NCT03161626 — Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery · completed
NCT03264157 — Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects · Phase 2, PHASE3 · completed
NCT01811875 — Post-Marketing Safety Study Following Long-Term Prophylactic OptivateTreatment in Subjects With Severe Haemophilia A · Phase 4 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01884311 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bio Products Laboratory
Last refreshed: 12 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01884311.

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