NA

• 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

Countries of recruitment

Bulgaria, Czech Republic, France, Germany, India, Poland, Romania, Russian Federation, Ukraine

Contacts

• Name: Clinical Research Department
• Affiliation: Octapharma Pharmazeutika Produktionsgesellschaft mbH

• Name: Clinical Research Department
• 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)

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).

Main Objective: To assess the efficacy of NewGam in correcting the platelet count.

Timepoint(s) of evaluation of this end point: See protocol

Secondary Objective: To evaluate the safety of NewGam.

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)

NGAM-02

NCT01349790

Source(s) of Monetary Support

Octapharma AG

Octapharma Pharmazeutika Produktionsgesellschaft mbH