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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: 6 October 2015
Main ID:  EUCTR2009-014589-24-DE
Date of registration: 12/04/2011
Prospective Registration: Yes
Primary sponsor: Octapharma AG
Public title: NA
Scientific title: Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02
Date of first enrolment: 22/09/2011
Target sample size: 95
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-014589-24
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Bulgaria Czech Republic France Germany India Poland Romania Russian Federation
Ukraine
Contacts
Name: Clinical Research Department   
Address:  Oberlaaer Straße 235 A-1100 Vienna Austria
Telephone: +431610321788
Email: birgit.taumberger@octapharma.com
Affiliation:  Octapharma Pharmazeutika Produktionsgesellschaft mbH
Name: Clinical Research Department   
Address:  Oberlaaer Straße 235 A-1100 Vienna Austria
Telephone: +431610321788
Email: birgit.taumberger@octapharma.com
Affiliation:  Octapharma Pharmazeutika Produktionsgesellschaft mbH
Key inclusion & exclusion criteria
Inclusion criteria:
1. Age of at least 18 years and 65 years at maximum.
2. Confirmed diagnosis of chronic primary ITP of at least 12 months duration (diagnosed with threshold platelet count less than 100x10 exp9/L)
3. Platelet count of no more than 20x10exp9/L at 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 95
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Primary Immune Thrombocytopenia (ITP)
MedDRA version: 15.0 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: NewGAM
Product Code: NewGAM
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Immunglobulin
CAS Number: 308067-58-5
Current Sponsor code: NewGam
Other descriptive name: IMMUNOGLOBULIN G
Concentration unit: % percent
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)
Main Objective: To assess the efficacy of NewGam in correcting the platelet count.
Primary end point(s): The primary efficacy measure is defined as an increase in platelets to at least 50x10 exp9/L within 7 days after the first infusion, i.e. by study Day 8 (at least once prior to Day 9).
Secondary Objective: To evaluate the safety of NewGam.
Timepoint(s) of evaluation of this end point: See protocol
Secondary Outcome(s)
Secondary end point(s): Secondary Efficacy Endpoints:
- Additional response rates (AR/CR)
Timepoint(s) of evaluation of this end point: See protocol
Secondary ID(s)
NCT01349790
NGAM-02
Source(s) of Monetary Support
Octapharma AG
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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