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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00811174
Recruitment Status : Terminated (Due to limited data available, efficacy, and PK analyses were not performed.)
First Posted : December 18, 2008
Results First Posted : July 14, 2017
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):

Brief Summary:
Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.

Condition or disease Intervention/treatment Phase
Immunologic Deficiency Syndromes Drug: Octagam 10% Phase 3

Detailed Description:

The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%.

The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases
Study Start Date : January 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Arm Intervention/treatment
Experimental: Octagam 10% Drug: Octagam 10%
300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: During infusion or within 72 hours after end of infusion ]
    Occurrence of Adverse Events

  2. 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 ]
    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

Secondary Outcome Measures :
  1. Vital Signs [ Time Frame: during each treatment ]
  2. Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis) [ Time Frame: at each treatment date (every three to four weeks) ]
  3. Assessment of Viral Safety [ Time Frame: Every three months ]
  4. Pre-next-dose Levels of Serum Total IgG [ Time Frame: before each treatment ]
  5. 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 ]
  6. Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00811174

Contact Barbara Pyringer at Octapharma/ Vienna/ Austria for information
Vienna, Austria, 1100
Sponsors and Collaborators
Study Director: Wolfgang Frenzel, Dr. Octapharma

Responsible Party: Octapharma Identifier: NCT00811174     History of Changes
Other Study ID Numbers: GAM10-03
First Posted: December 18, 2008    Key Record Dates
Results First Posted: July 14, 2017
Last Update Posted: July 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs