Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01349790
First received: May 5, 2011
Last updated: May 28, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


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 ]

Enrollment: 40
Study Start Date: June 2011
Study Completion Date: February 2014
Primary Completion Date: July 2013 (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:

  1. Age of at least 18 years and 80 years at maximum.
  2. Confirmed diagnosis of chronic primary ITP (threshold platelet count less than 100x10 exp9/L) of at least 12 months duration
  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.

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:

    • 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.
  3. Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01349790

Locations
Germany
Abdulgabar Salama
Berlin, Germany
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: May 28, 2014
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 August 20, 2014