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

NCT00811174 | Terminated Phase 3 Results

• 1 other identifier: GAM10-03
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunologic Deficiency Syndromes

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  Occurrence of Adverse Events

  During infusion or within 72 hours after end of infusion

• 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

  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

  after 6 months of treatment

Secondary Outcomes (6)

• Vital Signs

  during each treatment

• Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis)

  at each treatment date (every three to four weeks)

• Assessment of Viral Safety

  Every three months

• Pre-next-dose Levels of Serum Total IgG

  before each treatment

• Pre-next-dose Levels of IgG Subclasses (IgG1, IgG2, IgG3, IgG4) and Pre-next-dose Levels of Specific Antibodies Against Defined Infectious Agents

  before treatement 10 and 13 (of 13 or 17 treatments) and at the end

Study Arms (1)

Octagam 10%

EXPERIMENTAL

Drug: Octagam 10%

Interventions

Octagam 10% DRUG

300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)

Octagam 10%

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Octapharma: lead

Study Sites (1)

Contact Barbara Pyringer at Octapharma/ Vienna/ Austria for information

Vienna, 1100, Austria

Location

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Condition Hierarchy (Ancestors)

Immune System Diseases

Results Point of Contact

• Title: Michael Eppolito
• Organization: Octapharma

michael.eppolito@octapharma.com

201-604-1155

Study Officials

• Wolfgang Frenzel, Dr.

  Octapharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: January 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 14, 2017
• Results First Posted: July 14, 2017

Record last verified: 2017-06

Locations

AU (1)