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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT00811174
First received: December 17, 2008
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention Phase
Immunologic Deficiency Syndromes
 Drug: Octagam 10%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Adverse events [ Time Frame: During infusion or within 72 hours after end of infusion ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs [ Time Frame: during each treatment ] [ Designated as safety issue: Yes ]
  • laboratory parameters (hematology, clinical chemistry, direct Coombs test and urin analysis) [ Time Frame: at each treatment date (every three to four weeks) ] [ Designated as safety issue: Yes ]
  • Assessment of viral safety [ Time Frame: Every three months ] [ Designated as safety issue: Yes ]
  • Pre-next-dose levels of serum total IgG [ Time Frame: before each treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Therapeutic efficacy (number of infections, number of missed days at school/ work, number of hospitalisation days, and use of antibiotics) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: January 2009
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octagam 10% Drug: Octagam 10%
300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)

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.

  Eligibility

Ages Eligible for Study:   2 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811174

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

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT00811174     History of Changes
Other Study ID Numbers: GAM10-03
Study First Received: December 17, 2008
Last Updated: May 6, 2013
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on June 18, 2013