High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)

NCT01313507 | Completed Phase 3 Results DMC

• 1 other identifier: NGAM-05
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 6

Brief Summary

This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 \[NGAM-01\]) for 3 months. The primary objective of the study was to assess the safety and tolerability of high infusion rates of NewGam.

Conditions

Primary Immunodeficiency Disease

Keywords

Primary Immunodeficiency Disease; PID

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Experienced at Least 1 Adverse Event Causally Related to the Administration of the Study Drug

  An adverse event was considered to be causally related to the administration of the study drug if it judged to be probably or possibly related to the study drug, as assessed by the investigator.

  Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)

• Percentage of Participants Who Experienced at Least 1 Adverse Event Temporally Related to the Study Drug

  An adverse event was considered to be temporally related to the study drug if it started during an infusion or within 72 hours after the end of an infusion.

  Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)

Secondary Outcomes (1)

• Change From Baseline in the Quality of Life (QoL) at the End of the Study

  Baseline (follow-up visit of study NGAM-01) to the end of the study (follow-up visit of study NGAM-05) (up to 4 months)

Study Arms (1)

NewGam

EXPERIMENTAL

Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).

Biological: NewGam

Interventions

NewGam BIOLOGICAL

The initial dose and dosing interval for each participant was the dose and dosing interval the participant received at the end of the NGAM-01 study. The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as the minimum trough level of serum immunoglobulin G (IgG) was above 5 g/L. If the serum IgG trough level dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion.

NewGam

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Completion of the main study NGAM-01.
• At each of the last 3 infusions in the main study NGAM-01, administration of NewGam at the maximum infusion rate of 0.08 mL/kg/min and without the need for premedication.

You may not qualify if:

• Administration of any immunoglobulin infusion other than NewGam between conclusion of the NGAM-01 study and the beginning of the present study.
• A deviation of the subject's treatment interval of more than 7 days between the last infusion of NewGam in the NGAM-01 study and the first infusion of NewGam in the present study.

Sponsors & Collaborators

• Octapharma: lead

Study Sites (6)

University of California Irvine

Irvine, California, United States

Location

Immunoe Research Center

Centennial, Colorado, United States

Location

Rush Universtity Medical Center

Chicago, Illinois, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

Location

Midlands Pediatrics

Papillion, Nebraska, United States

Location

Seattle Children's Hospital

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine
• Organization: Octapharma USA

michael.eppolito@octapharma.com

201 604-1155

Study Officials

• James N Moy, MD

  Rush Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2011
• First Posted: March 11, 2011
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Locations

US (6)