Immune Thrombocytopenic PurpuraPhase 3NCT00426270
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
A Phase 3 study testing Octagam 10% in people with Immune Thrombocytopenic Purpura, run by Octapharma at 1 site in Austria.
Trial summary
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- Octagam 10%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2006to Sep 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.
- Platelet count ≤ 20 x 10^9/L.
Who cannot join
- Chronic refractory ITP patients.
- Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia.
- Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days before enrollment.
- Administration of thrombocyte concentrates within 72 hours before baseline.
- Experimental treatment (eg, rituximab) within 3 months before enrollment.
- Prophylactic preoperative treatment for elective splenectomy.
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- Severe liver or kidney disease.
- Pregnant or nursing female.
- History of hypersensitivity to blood or plasma derived products.
- Emergency operation.
- Live viral vaccination within the last month prior to study entry.
- Known IgA deficiency and antibodies against IgA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
Read the detailed description
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- Octagam 10%
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octagam 10%Drug
Also called Human normal immunoglobulin
Octagam 10% was supplied as a ready-to-use solution in glass bottles.
| Study group | Role | What they receive |
|---|---|---|
| Octagam 10% 1 g/kg/day | Experimental | Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days. Receives: Drug: Octagam 10% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Clinical Response
A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.
Measured: Day 2 to Day 7
Secondary outcomes (4)
Time to Achieve a Clinical Response
A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.
Measured: Day 2 to Day 7
Maximum Platelet Count
Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.
Measured: Day 2 to the end of the study (Day 63)
Duration of the Clinical Response
The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21.
Measured: Day 2 to the end of the study (Day 63)
Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7
The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention).
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startJun 2006
- Primary completionSep 2008
- Study completionSep 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Thrombocytopenic PurpuraStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Frenzel, MD, Study director, Octapharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426270
- Sponsor's protocol ID
- GAM10-02
- Status last verified
- Jul 2014
- First submitted
- 22 Jan 2007
- Last updated
- 1 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Robak T, Mainau C, Pyringer B, Chojnowski K, Warzocha K, Dmoszynska A, Straub J, Imbach P. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam(R) 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9. doi: 10.1179/102453310X12719010991867.
PubMed 20863431
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
- ClinicalTrials.gov ID
- NCT00426270
- Acronym / sponsor ID
- GAM10-02
- Conditions
- Immune Thrombocytopenic Purpura
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Jan 2007 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
Detailed description
The primary objective of the study was to investigate the efficacy of Octagam® 10% in correcting platelet count. The blood count as well as laboratory chemistry were checked repeatedly up to day 21.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.
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% 1 g/kg/day | Experimental | Drug: Octagam 10%Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.
- Platelet count ≤ 20 x 10^9/L.
Key exclusion criteria (12 listed)
- Chronic refractory ITP patients.
- Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia.
- Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days before enrollment.
- Administration of thrombocyte concentrates within 72 hours before baseline.
- Experimental treatment (eg, rituximab) within 3 months before enrollment.
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%Also: Human normal immunoglobulinOctagam 10% was supplied as a ready-to-use solution in glass bottles. | Drug | Octagam 10% 1 g/kg/day |
Primary outcome
Percentage of Participants With a Clinical Response
Time frame: Day 2 to Day 7
A clinical response is defined as an increase in platelet count to ≥ 50*10^9/L on any day from Day 2 to Day 7.
4 secondary outcomes
Time to Achieve a Clinical Response
Time frame: Day 2 to Day 7
Maximum Platelet Count
Time frame: Day 2 to the end of the study (Day 63)
Duration of the Clinical Response
Time frame: Day 2 to the end of the study (Day 63)
Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20863431Robak T, Mainau C, Pyringer B, Chojnowski K, Warzocha K, Dmoszynska A, Straub J, Imbach P. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam(R) 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9. doi: 10.1179/102453310X12719010991867.
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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, MD 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 Immune Thrombocytopenic Purpura, 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 1 Aug 2014. 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 8 May 2014). 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?
Percentage of Participants With a Clinical Response (time frame: Day 2 to Day 7). 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 NCT00426270, which also lists 1 linked publication.
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 1 Aug 2014.