Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia
This study is currently recruiting participants.
Verified April 2013 by Octapharma
Sponsor:
Octapharma
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01349790
First received: May 5, 2011
Last updated: April 10, 2013
Last verified: April 2013
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Purpose
NewGam (current working title for a new IGIV formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV). This study will evaluate the safety and efficacy NewGam 10% in patients with Primary Immune Thrombocytopenia.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary Thrombocytopenia |
Drug: NewGam 10% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Further study details as provided by Octapharma:
Primary Outcome Measures:
- Platelet Count [ Time Frame: Within 7 days of first infusion and at day 22 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Assessment of bleeding [ Time Frame: At baseline, then daily on Day 2 through Day 8, and on Day 15 and Day 22 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 95 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dosage Specificatiions
NewGam 10% 1.0 g/kg over a 2-day period for a total of 2.0 g/kg.
|
Drug: NewGam 10%
NewGam 10% is a newly developed human normal immunoglobulin solution ready for intravenous administration (IGIV
|
Detailed Description:
This is a Phase 3 study. The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count. The secondary objective of the study is to evaluate the safety of NewGam. Safety will be assessed by monitoring vital signs, physical examination, evaluation of adverse events (AE) recordings and laboratory parameters, and by viral safety testing.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age of at least 18 years and 80 years at maximum.
- Confirmed diagnosis of chronic primary ITP (threshold platelet count less than 100x10 exp9/L) of at least 12 months duration
- Platelet count of no more than 20x10exp9/L at with or without bleeding manifestations.
- Freely given written informed consent from patient.
- 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.
Exclusion Criteria:
- Thrombocytopenia secondary to other diseases (such as Acquired Immunodeficiency Syndrome [AIDS] or systemic lupus erythematosus [SLE]) or drug-related thrombocytopenia.
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:
- long-term corticosteroid therapy when the dose has been stable XML File Identifier: 20fm/JxgqgA8OuBLHG4vYshCP/k= Page 13/22 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.
- Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01349790
Contacts
| Contact: Birgit Taumberger | +43 (0)1 610 32 1788 | brigit.taumberger@octapharma.at |
Locations
| Germany | |
| Abdulgabar Salama | Recruiting |
| Berlin, Germany | |
| Contact: A - S, MD | |
| Principal Investigator: Abdulgabar Salama, MD | |
Sponsors and Collaborators
Octapharma
Investigators
| Principal Investigator: | Abdulgabar Salama, MD | Universitätsklinikum Charite, Med. Fakultät der Humboldt-Universität Berlin |
| Study Director: | Wolfgang Frenzel, MD | Octapharma |
More Information
No publications provided
| Responsible Party: | Octapharma |
| ClinicalTrials.gov Identifier: | NCT01349790 History of Changes |
| Other Study ID Numbers: | NGAM-02 |
| Study First Received: | May 5, 2011 |
| Last Updated: | April 10, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Paul-Ehrlich-Institut |
Keywords provided by Octapharma:
|
ITP Primary Immune Thrombocytopenia |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Immunoglobulins |
Antibodies Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013