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High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam) (NGAM-05)

Primary Purpose

Primary Immunodeficiency Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

NewGam

About this trial

This is an interventional treatment trial for Primary Immunodeficiency Disease focused on measuring Primary Immunodeficiency Disease, PID

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Any condition or circumstance that would have led to the exclusion of the subject from the NGAM-01 study.
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.

Sites / Locations

University of California Irvine
Immunoe Research Center
Rush Universtity Medical Center
Cardinal Glennon Children's Hospital
Midlands Pediatrics
Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NewGam

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

QoL was assessed with the Child Health Questionnaire-Parent Form (CHQ-PF50), completed by a parent or guardian, in participants < 14 years of age at the start of the previous study NGAM-01 and with the Short Form-36 Health Survey (SF-36-HS) in participants ≥ 14 years of age. The CHQ-PF50 consists of 50 items organized into 15 subscales.The 15 subscales could be combined into 2 summary scores, physical and psychosocial. The calculated scores were transformed so that each scale had a range of 0-100. A higher score indicates better health. The SF-36-HS is composed of 36 items. Responses to the 36 items were combined to create 8 scales. The 8 scales could be further combined into 2 scores: Physical component summary and mental component summary. The item and scale scores were transformed to a range of 0-100 with a mean of 50 and a standard deviation of 10 in the general US population. A higher score indicates better health. For both instruments, a positive change indicates improvement.

Full Information

NCT ID

NCT01313507

First Posted

March 9, 2011

Last Updated

February 8, 2017

Sponsor

Octapharma

1. Study Identification

Unique Protocol Identification Number

NCT01313507

Brief Title

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

Acronym

NGAM-05

Official Title

Clinical Study to Evaluate the Safety and Tolerability of Immunoglobulin Intravenous (Human) 10% (NewGam) Administered at High Infusion Rates to Patients With Primary Immunodeficiency Diseases (Extension of Study NGAM-01)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Octapharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Patients received NewGam via an infusion pump to control precise infusion rates. All NewGam infusions started at a rate of 0.01 mL/kg/min (60 mg/kg/h) for the first 30 minutes followed by 0.03 mL/kg/min (180 mg/kg/h) for the next 15 minutes. If tolerated, further increments were made at predefined patterns with the following maximum rates: 0.10 mL/kg/min (600 mg/kg/h) in the first infusion; if this was tolerated, 0.12 mL/kg/min (720 mg/kg/h) in the second infusion; if this was tolerated, 0.14 mL/kg/min (840 mg/kg/h) in all subsequent infusions. If an adverse event occurred during an infusion, the rate was reduced to half the rate at which the event occurred or the infusion was interrupted until symptoms subsided. The infusion was then resumed at a rate tolerated by the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Immunodeficiency Disease

Keywords

Primary Immunodeficiency Disease, PID

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NewGam

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

NewGam

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

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)

Title

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

Description

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.

Time Frame

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 Outcome Measure Information:

Title

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

Description

Time Frame

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Any condition or circumstance that would have led to the exclusion of the subject from the NGAM-01 study. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James N Moy, MD

Organizational Affiliation

Rush Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California Irvine

City

Irvine

State/Province

California

Country

United States

Facility Name

Immunoe Research Center

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

Rush Universtity Medical Center

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

Cardinal Glennon Children's Hospital

City

St. Louis

State/Province

Missouri

Country

United States

Facility Name

Midlands Pediatrics

City

Papillion

State/Province

Nebraska

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

Country

United States

12. IPD Sharing Statement

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

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