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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 23 December 2013
Main ID:  EUCTR2011-001354-29-IT
Date of registration: 07/03/2012
Prospective Registration: No
Primary sponsor: LFB BIOTECHNOLOGIES
Public title: An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
Scientific title: An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP)
Date of first enrolment: 09/11/2011
Target sample size: 40
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-001354-29
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1  
Phase: 
Countries of recruitment
Germany Hungary Italy Russian Federation Spain Ukraine
Contacts
Name: Start-up   
Address:  Via Winckelmann 2 20146 Milano Italy
Telephone: 0248958768
Email: stefania.giovanelli@premier-research.com
Affiliation:  Premier Research group srl
Name: Start-up   
Address:  Via Winckelmann 2 20146 Milano Italy
Telephone: 0248958768
Email: stefania.giovanelli@premier-research.com
Affiliation:  Premier Research group srl
Key inclusion & exclusion criteria
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: 0
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 (sbp> or = to160 mmHg and dbp> 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, 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,
- 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 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.
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 pregnancy urinary 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 contraceptives implants).
19. Anticipated poor compliance of patient with study procedures.
20. Use of loop diuretics within a week prior the inclusion.
21. History of alcohol or drug ab


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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)
MedDRA version: 14.1 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 10005329 - Blood and lymphatic system disorders
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Intervention(s)

Product Name: human normal immunoglobulin for intravenous use
Product Code: I10E
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: To assess the efficacy of I10E in increasing platelet count and controlling
bleedings in patients suffering from primary Immune ThrombocytoPenia
(ITP).
Primary end point(s): The primary endpoint is the number and percentage of patients with
responses (including complete responses) during the investigational
period.
Patients with response (R):
- Platelet counts > or = to 30 x 10 exp9/l and at least 2-fold increase of
baseline platelet count confirmed on at least 2 separate visits at least 7
days apart.
- And absence of new bleeding.
ยท Patients with complete response (CR):
- Platelet count > or = to 100 x 10 exp9/l, confirmed on at least 2
separate visits at least 7 days apart.
- And absence of new bleeding.
Secondary Objective: To assess the biological and clinical safety profile of I10E.
Timepoint(s) of evaluation of this end point: confirmed on at least 2 separate visits at least 7 days apart during the
study period.
Secondary Outcome(s)
Secondary end point(s): Efficacy criteria:
- Number and % of patients with complete response (CR) during the
investigational period.
- Time to response i.e. time from starting treatment to time of platelet
response achievement (platelet count > or = to 30 x 10 exp9/l) in the
responder
population.
- Maximum platelet counts and time to reach the maximum platelet
count.
- Number and % of non-responders patients (NR) during the
investigational period.
- Number and % of patients with a loss of R and CR during the
investigational period.
- Duration of response defined as the number of days from the first day
of the response (CR or R) to the first day of the loss of response (CR or
R).
- Number and % of patients with platelet count > or = to 50 x 10 exp9/l
at Day 5, Day 6 and Day 7.
- Evaluation of pre-existing bleedings (Khellaf score and WHO score
assessed at baseline, Day 2, Day 14 and Day 30)
Timepoint(s) of evaluation of this end point: see details provided in section Secondary end-point
Secondary ID(s)
2011-001354-29-DE
I10E-0719
Source(s) of Monetary Support
LFB BIOTECHNOLOGIES
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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