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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: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01349790
Date of registration: 05/05/2011
Prospective Registration: Yes
Primary sponsor: Octapharma
Public title: Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia
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
Date of first enrolment: October 2011
Target sample size: 40
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01349790
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Germany
Contacts
Name:     Wolfgang Frenzel, MD
Address: 
Telephone:
Email:
Affiliation:  Octapharma AG
Name:     Abdulgabar Salama, MD
Address: 
Telephone:
Email:
Affiliation:  Universitätsklinikum Charite, Med. Fakultät der Humboldt-Universität Berlin
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Age of = 18 and = 65 years.

2. Confirmed diagnosis of chronic primary immune thrombocytopenia (ITP) (diagnosed with a
threshold platelet count < 100x10^9/L) of at least 12 months duration.

3. Platelet count of no more than 20x10^9/L 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 gonadotropin [HCG]-based assay) and need to practice contraception using a
method of proven reliability for the duration of the study.

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 immunoglobulin or
thrombopoietin receptor agonists, or other platelet enhancing drugs (including
immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrollment,
except for:

- 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.

- 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: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Primary Thrombocytopenia
Intervention(s)
Drug: NewGam
Primary Outcome(s)
Percentage of Responders [Time Frame: Day 1 to Day 8]
Secondary Outcome(s)
Bleeding Intensity [Time Frame: Day 1 to Day 22]
Duration of a Complete Response [Time Frame: Day 1 to Day 22]
Duration of a Response [Time Frame: Day 1 to Day 22]
Duration of an Alternative Response [Time Frame: Day 1 to Day 22]
Maximum Platelet Count [Time Frame: Day 1 to Day 22]
Percentage of Alternative Responders [Time Frame: Day 1 to Day 22]
Percentage of Alternative Responders Who Lost the Response [Time Frame: Day 1 to Day 22]
Percentage of Complete Responders [Time Frame: Day 1 to Day 22]
Percentage of Complete Responders Who Lost the Response [Time Frame: Day 1 to Day 22]
Percentage of Participants Who Achieved a Platelet Count > 30x10^9/L [Time Frame: Day 1 to Day 2]
Percentage of Responders Who Achieved a Normal Platelet Count [Time Frame: Day 1 to Day 22]
Platelet Count by Visit [Time Frame: Day 1 to Day 22]
Time to a Complete Response [Time Frame: Day 1 to Day 22]
Time to a Response [Time Frame: Day 1 to Day 8]
Time to an Alternative Response [Time Frame: Day 1 to Day 22]
Secondary ID(s)
2009-014589-24
NGAM-02
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 07/06/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01349790
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