NCT01349790

Brief Summary

NewGam is a newly developed human normal immunoglobulin solution for intravenous administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in patients with primary immune thrombocytopenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 5, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

June 7, 2017

Completed
Last Updated

June 7, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

May 5, 2011

Results QC Date

March 22, 2017

Last Update Submit

May 4, 2017

Conditions

Primary Thrombocytopenia

Keywords

ITPPrimary immune thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Percentage of Responders

    A responder is a study participant with an increase in platelets to ≥ 50x10\^9/L within 7 days after the first infusion, ie, by study Day 8.

    Day 1 to Day 8

Secondary Outcomes (15)

  • Percentage of Alternative Responders

    Day 1 to Day 22

  • Percentage of Complete Responders

    Day 1 to Day 22

  • Percentage of Alternative Responders Who Lost the Response

    Day 1 to Day 22

  • Percentage of Complete Responders Who Lost the Response

    Day 1 to Day 22

  • Time to a Response

    Day 1 to Day 8

  • +10 more secondary outcomes

Study Arms (1)

NewGam

EXPERIMENTAL

Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.

Drug: NewGam

Interventions

NewGamDRUG

NewGam is a solution of human normal immunoglobulin 10% treated with solvent/detergent and nanofiltered for intravenous administration.

NewGam

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of ≥ 18 and ≤ 65 years.
  • Confirmed diagnosis of chronic primary immune thrombocytopenia (ITP) (diagnosed with a threshold platelet count \< 100x10\^9/L) of at least 12 months duration.
  • Platelet count of no more than 20x10\^9/L 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 gonadotropin \[HCG\]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study.

You may not qualify if:

  • 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 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.
  • Unresponsive to previous treatment with IGIV or anti-D immunoglobulin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdulgabar Salama

Berlin, Germany

Location

Related Publications (1)

  • Arbach O, Taumberger AB, Wietek S, Cervinek L, Salama A. Efficacy and safety of a new intravenous immunoglobulin (Panzyga(R) ) in chronic immune thrombocytopenia. Transfus Med. 2019 Feb;29(1):48-54. doi: 10.1111/tme.12573. Epub 2019 Jan 27.

    PMID: 30687970DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Results Point of Contact

Title
Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine
Organization
Octapharma USA
michael.eppolito@octapharma.com
201 604-1155

Study Officials

  • Abdulgabar Salama, MD

    Universitätsklinikum Charite, Med. Fakultät der Humboldt-Universität Berlin

    PRINCIPAL INVESTIGATOR

  • Wolfgang Frenzel, MD

    Octapharma AG

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2011

First Posted

May 9, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

June 7, 2017

Results First Posted

June 7, 2017

Record last verified: 2017-05

Locations

DE(1)