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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01313507
• Date of registration: 09/03/2011
• Prospective Registration: Yes
• Primary sponsor: Octapharma
• Public title: High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam) NGAM-05
• Scientific 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)
• Date of first enrolment: May 2011
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01313507
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: James N Moy, MD
• Affiliation: Rush Medical Center

Key inclusion & exclusion 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.



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

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency Disease

Intervention(s)

Biological: NewGam

Primary Outcome(s)

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

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

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

NGAM-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01313507