Back to results

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

Primary Purpose

Immunologic Deficiency Syndromes

Status

Terminated

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

Octagam 10%

About this trial

This is an interventional treatment trial for Immunologic Deficiency Syndromes

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Contact Barbara Pyringer at Octapharma/ Vienna/ Austria for information

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Octagam 10%

Arm Description

Outcomes

Primary Outcome Measures

Adverse Events

Occurrence of Adverse Events

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

Secondary Outcome Measures

Vital Signs

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

Assessment of Viral Safety

Pre-next-dose Levels of Serum Total IgG

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

Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)

Full Information

NCT ID

NCT00811174

First Posted

December 17, 2008

Last Updated

June 16, 2017

Sponsor

Octapharma

1. Study Identification

Unique Protocol Identification Number

NCT00811174

Brief Title

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

Official Title

Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Due to limited data available, efficacy, and PK analyses were not performed.

Study Start Date

January 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Octapharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immunologic Deficiency Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Octagam 10%

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Octagam 10%

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse Events

Description

Occurrence of Adverse Events

Time Frame

During infusion or within 72 hours after end of infusion

Title

Description

Time Frame

after 6 months of treatment

Secondary Outcome Measure Information:

Title

Vital Signs

Time Frame

during each treatment

Title

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

Time Frame

at each treatment date (every three to four weeks)

Title

Assessment of Viral Safety

Time Frame

Every three months

Title

Pre-next-dose Levels of Serum Total IgG

Time Frame

before each treatment

Title

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

Title

Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wolfgang Frenzel, Dr.

Organizational Affiliation

Octapharma

Official's Role

Study Director

Facility Information:

Facility Name

Contact Barbara Pyringer at Octapharma/ Vienna/ Austria for information

City

Vienna

ZIP/Postal Code

1100

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs