A clinical study to evaluate the efficacy and safety of immunoglobulin intravenous (human) 10% (NewGam) in Primary Immune Thrombocytopenia, Is the condition of having an abnormally low platelet count (thrombocytopenia) of no known cause.
- Conditions
- Health Condition 1: null- Primary Immune Thrombocytopenia (ITP)
- Registration Number
- CTRI/2011/11/002098
- Lead Sponsor
- OCTAPHARMA AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 95
1. Age of >=18 years and <=65 years.
2. Confirmed diagnosis of chronic primary ITP (threshold platelet count less than 100x109/L) of at least 12 months duration and fulfilling the following criteria:
a) history and physical examination excluding other causes of thrombocytopenia b) pattern of bleeding associated with platelet disorders using the verbal rating scale according to Buchanan (2002) [8].
c) isolated thrombocytopenia in the blood count; apart from thrombocytopenia, the blood count is normal for the patientâ??s age, or if abnormal, readily explained
d) peripheral blood smear consistent with ITP: thrombocytopenia with platelets of normal size or slightly larger than normal, with absence of platelet clumps and giant platelets; normal red and white blood cell morphology
e) when any abnormal finding is present, additional diagnostic evaluation exclude other causes of thrombocytopenia.
3. Platelet count of <=20x109/L with or without bleeding manifestations.
4.Freely given written informed consent from patient.
5.Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.
Note:In India as per the DCGI cap we will include patients from the age of 18 to 65 yrsâ??
1.Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia.
2.Administration of intravenous immunoglobulin (IGIV), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment, except for:
a) 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.
b) 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.
3.Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
4.Experimental treatment (e.g. Rituximab) within 3 months before enrollment.
5.Splenectomy in the previous 4 weeks or planned splenectomy throughout the study period.
6.Subject with Evans syndrome (autoimmune thrombocytopenia and autoimmune hemolysis).
7.Known or suspected human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection
8.Live viral vaccination within the last two months before study entry.
9.Emergency operation.
10. Severe liver or kidney disease (alanine aminotransferase [ALAT] 3x > upper limit of normal, creatinine >120 µmol/L).
11. Congestive heart failure New York Heart Association (NYHA) class III or IV.
12. Non-controlled arterial hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >90 mmHg).
13. History of hypersensitivity to blood or plasma derived products, or any component of the investigational product.
14. Known immunoglobulin A (IgA) deficiency and antibodies against IgA.
15. History of, or suspected alcohol or drug abuse.
16. Pregnant or nursing women.
17. Unable or unwilling to comply with the study protocol.
18. Participating in another interventional clinical study and receiving investigational medicinal product within three months before study entry.
19. Patients with body mass index >= 30kg /m2
20. Patients with risk factors(i) for thromboembolic events in whom the risks outweigh the potential benefit of NewGam treatment
(i) Such as obesity,advanced age , hypertension, diabetes, a history of atheroschlerosis/vascular disease or thrombotic events , hyperlipidaemia, multiple cardiovascular risk factors, acquired or inherited thrombophilic disorders, prolonged periods of immobilization, severe hypvoleamia, central venous catheterization, active malignancy and/or known or suspected hyperviscosity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count.Timepoint: Day 8
- Secondary Outcome Measures
Name Time Method The secondary objective of the study is to evaluate the safety and the efficacy of NewGam.Timepoint: Efficacy outcome- Day 22 <br/ ><br>Safety Outcome- Day 63 <br/ ><br>