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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014