NCT00162006

Brief Summary

The purpose of this study is to evaluate whether Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution is an effective and safe treatment in patients with chronic idiopathic thrombocytopenic purpura.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2003

Shorter than P25 for phase_2

Geographic Reach
4 countries

11 active sites

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

Study Start

First participant enrolled

January 13, 2003

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

September 8, 2005

Last Update Submit

April 29, 2021

Conditions

Immune Thrombocytopenic Purpura (ITP)

Keywords

Chronic idiopathic thrombocytopenic purpura

Outcome Measures

Primary Outcomes (1)

  • Subjects Who Qualify As Treatment Responders

    Subjects who i) had at least one platelet count of ≥50 x 109/L prior to Day 15 and ii) did not require a booster dose prior to Day 15, where Day 15 refers to the fifteenth day after initiation of treatment (Day 1). Otherwise, the subject is a non-responder.

    Baseline thru Day 15 post treatment

Secondary Outcomes (28)

  • Time to achieve a platelet count > 50 x 109/L

    Screening visit

  • Time to achieve a platelet count > 50 x 109/L

    Day 1 (initiation of treatment)

  • Time to achieve a platelet count > 50 x 109/L

    Day 2

  • Time to achieve a platelet count > 50 x 109/L

    Day 5

  • Time to achieve a platelet count > 50 x 109/L

    Day 8

  • +23 more secondary outcomes

Interventions

Immune Globulin Intravenous (Human), 10% Triple Virally Reduced SolutionDRUG

Eligibility Criteria

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

You may qualify if:

  • Age \>= 18 and \<= 65 years
  • ITP diagnosed at least 6 months prior to study entry by history, physical exam, blood count and blood smear
  • Baseline platelet count of \<= 20 x 10 to the 9th/L determined prior to administration of the study drug on the day of the first infusion
  • No IVIG treatment for ITP during the two weeks prior to the first infusion of the study drug
  • For females of child bearing potential, use of adequate birth control measures during study participation
  • Written informed consent

You may not qualify if:

  • Serum values of ALT, AST, alkaline phosphatase, and total bilirubin exceeding 2.5 times the upper limit of normal at screening
  • Renal dysfunction defined as serum creatinine greater than or equal to 2 mg/dL at screening
  • Underlying other autoimmune or lymphoproliferative disorder
  • Uncontrolled hypertension
  • Cardiac insufficiency NYHA III and IV, coronary heart disease (CHD) NYHA III and IV
  • Malignancy or history of malignancy
  • Documented selective IgA deficiency (\<= 10 mg/dL)
  • Treatment with another investigational drug in the four weeks prior to study entry or current treatment with another investigational product
  • History of severe adverse reactions to blood and/or blood products
  • Pregnancy or lactation
  • Positivity for HIV, or HCV antibodies, or HBsAg
  • History of unresponsiveness to IVIG defined as a peak increment in platelet count \<= 20,000/µL coincident with the last IVIG treatment course prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Hradec Králové, Czechia

Location

Unknown Facility

Olomouc, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Giessen, Germany

Location

Unknown Facility

Halle, Germany

Location

Unknown Facility

Debrecen, Hungary

Location

Unknown Facility

Győr, Hungary

Location

Unknown Facility

Szeged, Hungary

Location

Unknown Facility

Szombathely, Hungary

Location

Unknown Facility

Lodz, Poland

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

gamma-Globulins

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

Intervention Hierarchy (Ancestors)

ImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 13, 2005

Study Start

January 13, 2003

Primary Completion

December 3, 2003

Study Completion

December 3, 2003

Last Updated

May 3, 2021

Record last verified: 2021-04

Locations

HU(4)DE(2)PL(1)CZ(4)