Phase 3
Completed N=40
Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia
Primary Thrombocytopenia
Source: ClinicalTrials.gov NCT01349790 ↗
Enrolled (actual)
40
Serious AEs
15.0%
Results posted
Jun 2017
Primary outcomePrimary: Percentage of Responders — 80.6 Percentage of participants
◆ Published Evidence
Emerging
14citations · ~2 / year
Efficacy and safety of a new intravenous immunoglobulin (Panzyga<sup>®</sup> ) in chronic immune thrombocytopenia.
Summary
NewGam is a newly developed human normal immunoglobulin solution for intravenous administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in patients with primary immune thrombocytopenia.
Linked Publications
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Efficacy and safety of a new intravenous immunoglobulin (Panzyga<sup>®</sup> ) in chronic immune thrombocytopenia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders |
80.6 | — |
| SECONDARY Percentage of Alternative Responders |
66.7 | — |
| SECONDARY Percentage of Complete Responders |
50.0 | — |
| SECONDARY Percentage of Alternative Responders Who Lost the Response |
45.8 | — |
| SECONDARY Percentage of Complete Responders Who Lost the Response |
77.8 | — |
| SECONDARY Time to a Response |
2.0 | — |
| SECONDARY Time to an Alternative Response |
1.0 | — |
| SECONDARY Time to a Complete Response |
2.0 | — |
| SECONDARY Duration of a Response |
14.0 | — |
| SECONDARY Duration of an Alternative Response |
18.5 | — |
| SECONDARY Duration of a Complete Response |
12.5 | — |
| SECONDARY Platelet Count by Visit |
8.8; 41.6; 115.0; 154.6; 168.2; 179.3 | — |
| SECONDARY Maximum Platelet Count |
236.9 | — |
| SECONDARY Percentage of Responders Who Achieved a Normal Platelet Count |
79.3 | — |
| SECONDARY Bleeding Intensity |
100.0; 100.0; 100.0; 36.1; 91.2; 72.2 | — |
| SECONDARY Percentage of Participants Who Achieved a Platelet Count > 30x10^9/L |
55.0; 77.5 | — |
Eligibility Criteria
Inclusion Criteria
- Age of ≥ 18 and ≤ 65 years.
- Confirmed diagnosis of chronic primary immune thrombocytopenia (ITP) (diagnosed with a threshold platelet count < 100x10^9/L) of at least 12 months duration.
- Platelet count of no more than 20x10^9/L with or without bleeding manifestations.
- Freely given written informed consent from patient.
- Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropin [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.
Exclusion Criteria
- Thrombocytopenia secondary to other diseases (such as acquired immunodeficiency syndrome [AIDS] or systemic lupus erythematosus [SLE]), or drug-related thrombocytopenia.
- Administration of intravenous immunoglobulin (IGIV), anti-D immunoglobulin or thrombopoietin receptor agonists, or other platelet enhancing drugs (including immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment, except for:
- Long-term corticosteroid therapy when the dose has been stable during the preceding 3 weeks and no dosage change is planned until study Day 22.
- Long-term azathioprine, cyclophosphamide, or attenuated androgen therapy when the dose has been stable during the preceding 3 months and no dosage change is planned until study Day 22.
- Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
Data sourced from ClinicalTrials.gov (NCT01349790) and the linked publication. 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. Informational only — not medical advice.