Phase 3
N=116
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults
Immune Thrombocytopenic Purpura
Bottom Line
View on ClinicalTrials.gov: NCT00426270 ↗Enrolled (actual)
116
Serious AEs
12.1%
Results posted
May 2014
Primary outcome: Primary: Percentage of Participants With a Clinical Response — 80.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Octagam 10% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Octapharma
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Clinical Response |
80.0 | — |
| SECONDARY Time to Achieve a Clinical Response |
2.1 | — |
| SECONDARY Maximum Platelet Count |
221.6 | — |
| SECONDARY Duration of the Clinical Response |
24.1 | — |
| SECONDARY Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7 |
80.9; 13.0; 2.6; 0.9; 2.6 | — |
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. 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%.
Eligibility Criteria
Key Inclusion Criteria
- Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.
- Platelet count ≤ 20 x 10^9/L.
Key Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT00426270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.