Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00811174
• Date of registration: 17/12/2008
• Prospective Registration: Yes
• Primary sponsor: Octapharma
• Public title: Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases
• Scientific title: Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases
• Date of first enrolment: January 2009
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00811174
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Austria

Contacts

• Name: Wolfgang Frenzel, Dr.
• Affiliation: Octapharma

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of primary immunodeficiency (acc. WHO)

- Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions
intervals

- Documented IgG trough levels of the two previous infusions before enrollment with a
value of at least 5.5 g/L for both

Exclusion Criteria:

- Acute infection requiring intravenous antibiotic treatment within two weeks before
screening

- Exposure to blood or any blood product or derivative other than commercially available
Octagam 5%, within the past 3 months

- History of hypersensitivity to blood or plasma derived products

- Requirement of any routine premedication for IGIV treatment

- History of congenital impairment of pulmonary function

- Severe liver function impairment

- Severe renal function impairment or predisposition for acute renal failure

- History of autoimmune haemolytic anaemia

- History of diabetes mellitus

- Congestive heart failure NYHA III or IV

- Non-controlled arterial hypertension

- History of DVT or thrombotic complications with IGIV treatment

- Known infection with HIV, HCV or HBV

- Treatment with steroids, immunosuppressive or immunomodulatory drugs

- Planned vaccination during study period

- Pregnant or nursing woman



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

Health Condition(s) or Problem(s) studied

Immunologic Deficiency Syndromes

Intervention(s)

Drug: Octagam 10%

Primary Outcome(s)

Pharmacokinetics of Serum Total IgG and IgG Subclasses (IgG1, IgG2, IgG3 and IgG4) and Pharmacokinetics of Specific Antibodies Against Defined Infectious Agents Comparing Octagam 5% Treatment With Octagam 10% Treatment [Time Frame: after 6 months of treatment]

Adverse Events [Time Frame: During infusion or within 72 hours after end of infusion]

Secondary Outcome(s)

Vital Signs [Time Frame: during each treatment]

Pre-next-dose Levels of Serum Total IgG [Time Frame: before each treatment]

Assessment of Viral Safety [Time Frame: Every three months]

Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis) [Time Frame: at each treatment date (every three to four weeks)]

Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents [Time Frame: before treatement 10 and 13 (of 13 or 17 treatments) and at the end]

Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics) [Time Frame: 12 months]

Secondary ID(s)

GAM10-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/07/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00811174