An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 38

Inclusion Criteria

1. Both genders

2. Age between 18 to 65 year old

3. Chronic Primary ITP
- ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009):
? Isolated thrombocytopenia diagnosed with platelet count
<100 x 10exp9/l and no abnormality of cells of other haematological
lineage and,
? Normal bone marrow (if available), or history of response to an
ITP treatment (corticosteroids, IVIg, anti-D) and,
? Failure to find any other causes of thrombocytopenia.

- Chronic ITP with bleeding(s) or an increased risk of bleeding:
? More than 12 months from diagnosis of ITP and,
? Platelet counts < 30 x 10exp9/l at the time of inclusion.
Note: Refractory ITP may be included and is defined by the failure to achieve a response or by the loss of response after splenectomy and the need of treatment (s) to minimize the risk of bleeding considered as clinically
significant by the investigator.

4. Written informed consent.
5. Patient is covered by health care insurance system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Known hypersensitivity to the active substance or to any of the excipients.

2. Patient with IgA deficiency except if the absence of anti IgA antibodies is documented.

3. History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, or severe hypertension (systolic blood pressure > or = to160 mmHg and diastolic blood pressure > or = to 100 mmHg).

4. History of thrombotic episodes (including deep vein thrombosis, myocardial infarction, cerebrovascular accident, pulmonary embolism) within the last 12 months.

5. Patient known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus.

6. Treatment that could induce thrombocytopenia within 15 days prior to inclusion.

7. Recent previous treatment, the action of which may interfere with the assessment of the investigational medicinal product:
- Initiation of corticosteroids or regular increase in the steroid dose within the last 4 weeks (EMA/CHMP/BPWP/94033/2007 rev.2),
- IVIg within the last 4 weeks,
- Anti-D within the last 4 weeks,
- Cyclosporin A within 4 weeks,
- Immunomodulator (as vincristin, vinblastin) within the last month,
- Immunosuppressor (azathioprine, cyclophosphamide) within the last 4 weeks,
- Anti-CD20 (rituximab) within the last 4 months,
- Antigonadotropin Hormone (danazol) within the last 6 months,
- Thrombopoietin receptors agonist (eltrombopag, romiplostim) within the last 4 weeks,

8. Splenectomy required during the study period or within the two previous months.

9. Severe haemorrhagic syndrome whether life-threatening or not, such as intracranial haemorrhage, gastrointestinal haemorrhage, gynaecological
haemorrhage with deglobulisation of more than 2g/dL or major cutaneous-mucosal haemorrhagic syndrome.

10. Severe bleeding or planned surgery requiring platelets transfusion at time of inclusion, or whole blood transfusion.

11. Plasma exchange 4 weeks before inclusion.

12. Concomitant disease that may induce a secondary immune thrombocytopenia, as:
- Clinical active systemic lupus erythematous with more than 4 American College of Rheumatology criteria,
- Lymphoproliferative disease or active malignant condition requiring antineoplastic or cytotoxic treatment.

13. Known hepatic disorder including total bilirubin > 2 x upper limit of normal range, alanine aminotransferase (ALT) or aspartate amino transferase (AST) > 3 x upper limit of normal range.

14. Known chronic renal insufficiency or creatinine clearance values < 80 ml/min in adult patients (Modified Diet in Renal Disease calculation).

15. Medical history of haemolysis or haemolytic anaemia during prior IVIg therapy or any other concomitant disease of clotting system (i.e. haemophilia).

16. Administration of another investigational medicinal product within the last month.

17. Any serious medical condition that would interfere with the clinical assessment of I10E or prevent the patient to comply with the protocol requirements.

18. Pregnant with positive results on a urine pregnancy test or breastfeeding woman, or woman of childbearing potential without effective contraception (effective contraception are: injectable, patch or combined
oral estro-progestative or progestative contraceptives, intra-uterine devices of type 'copper T' and levonorgest releasing IU systems, depot intramuscular medroxyprogesteron, subcutaneous implants of
progestative contraceptive implants, barrier methods of contrac

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials