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

PHASE3CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

August 20, 2015

Primary Completion Date

May 25, 2017

Study Completion Date

May 25, 2017

Conditions
Primary Immune Deficiency DisordersCommon Variable ImmunodeficiencyX-linked AgammaglobulinaemiaHyperimmunoglobulin M Syndrome
Interventions
BIOLOGICAL

Subgam

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.

Trial Locations (16)

22030

O&O Alpan, LLC, Fairfax

33408

Allergy Associate of the Palm Beaches, North Palm Beach

43235

Optimed Research, Columbus

53226

The Medical College of Wisconsin/Children's Hospital of Wisconsin, Milwaukee

60611

Ann and Robert H Lurie Children's Hospital, Chicago

63104

Cardinal Glennon Children's Medical Center, Minneapolis

73131

Oklahoma Institute of Allergy & Asthma Clinical Research, LLC, Oklahoma City

75230

Dallas Allergy Immunology, Dallas

75231

AARA Research Center, Dallas

80112

Immunoe International Research, Centennial

84112

University of Utah, Salt Lake City

85224

Arizona Allergy Associates, Chandler

92123

University of California San Diego-- Rady's Children's Hospital, San Diego

92697

University of California, Irvine, Irvine

98225

Bellingham Asthma Allergy Clinic, Bellingham

174033

Pennsylvania State University, Hershey

Sponsors
All Listed Sponsors
lead

Bio Products Laboratory

OTHER

NCT01884311 - Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases | Biotech Hunter | Biotech Hunter