Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0 Level: LLT Classification code 10023095 Term: ITP System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
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: IMM
Sponsors
Octapharma AG
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of NewGam in correcting the platelet count.;Secondary Objective: To evaluate the safety of NewGam.;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). ;Timepoint(s) of evaluation of this end point: See protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: - Additional response rates (AR/CR) ;Timepoint(s) of evaluation of this end point: See protocol | — |
Countries
Bulgaria, Czech Republic, France, Germany, India, Poland, Romania, Russian Federation, Ukraine
Contacts
Public ContactClinical Research Department
Octapharma Pharmazeutika Produktionsgesellschaft mbH
Outcome results
None listed