Immunologic Deficiency SyndromesPhase 3NCT00811174

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

A Phase 3 study testing Octagam 10% in people with Immunologic Deficiency Syndromes, run by Octapharma at 1 site in Austria.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 2 to 75 years
Conditions the study is for: Immunologic Deficiency Syndromes
What is being tested?: Octagam 10%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteAustria
Study dates: Jan 2009to Sep 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

Contact Barbara Pyringer at Octapharma/ Vienna/ Austria for information
Vienna, 1100

Other trials in Austria

About this study

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

Read the 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.

Conditions: Immunologic Deficiency Syndromes
Being tested: Octagam 10%
Medical subject headings: Immunologic Deficiency Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Octagam 10%Drug
300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)

Study groups in NCT00811174
Study group	Role	What they receive
Octagam 10%	Experimental	Not described Receives: Drug: Octagam 10%

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Events
Occurrence of Adverse Events
Measured: 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
Measured: after 6 months of treatment

Secondary outcomes (6)

Vital Signs
Measured: during each treatment
Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis)
Measured: at each treatment date (every three to four weeks)
Assessment of Viral Safety
Measured: Every three months
Pre-next-dose Levels of Serum Total IgG
Measured: 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
Measured: before treatement 10 and 13 (of 13 or 17 treatments) and at the end
Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Sep 2010

First posted18 Dec 2008 (estimated)
Study startJan 2009
Primary completionSep 2010
Study completionSep 2010

Why it stopped: Due to limited data available, efficacy, and PK analyses were not performed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Immunologic Deficiency SyndromesStudies of the same condition, open and under way.
More trials run by OctapharmaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00811174
Sponsor's protocol ID: GAM10-03
Status last verified: Jun 2017
First submitted: 17 Dec 2008
Last updated: 14 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Immunologic Deficiency Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Efficacy, Safety and Kinetics of Octagam 10% for Replacement Therapy in Primary Immunodeficiency Diseases
ClinicalTrials.gov ID: NCT00811174
Acronym / sponsor ID: GAM10-03
Conditions: Immunologic Deficiency Syndromes
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to limited data available, efficacy, and PK analyses were not performed.
Enrolment: 5 participants (actual)
Lead sponsor: OctapharmaIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 18 Dec 2008 (estimated)
Results: Posted 14 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Octagam 10%	Experimental	Drug: Octagam 10%

Who may qualify

Ages: 2 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Octagam 10%300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)	Drug	Octagam 10%

Primary outcome

Adverse Events
Time frame: During infusion or within 72 hours after end of infusion
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
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

6 secondary outcomes

Vital Signs
Time frame: during each treatment
Laboratory Parameters (Hematology, Clinical Chemistry, Direct Coombs Test and Urin Analysis)
Time frame: at each treatment date (every three to four weeks)
Assessment of Viral Safety
Time frame: Every three months
Pre-next-dose Levels of Serum Total IgG
Time frame: 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
Time frame: before treatement 10 and 13 (of 13 or 17 treatments) and at the end
Therapeutic Efficacy (Number of Infections, Number of Missed Days at School/ Work, Number of Hospitalisation Days, and Use of Antibiotics)
Time frame: 12 months

Results and safety

Results posted to the registry on 14 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Octagam 10%	5	2

Primary outcome: Adverse Events

Time frame: During infusion or within 72 hours after end of infusion. Number. Unit: participants

Measure	Octagam 10% n = 5
Value	4

Primary outcome: 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

Population analysed: Due to premature termination of the study, data were unavailable and no analysis was done.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 Months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Octagam 10%	1 of 5 (20%)	5 of 5 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wolfgang Frenzel, Dr. study director

Octapharma

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Octagam 10% in people with Immunologic Deficiency Syndromes, run by Octapharma at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: During infusion or within 72 hours after end of infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00811174.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.