NCT00426270

Brief Summary

Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2006

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

Study Start

First participant enrolled

June 1, 2006

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

May 8, 2014

Completed
Last Updated

August 1, 2014

Status Verified

July 1, 2014

Enrollment Period

2.3 years

First QC Date

January 22, 2007

Results QC Date

April 7, 2014

Last Update Submit

July 28, 2014

Conditions

Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Clinical Response

    A clinical response is defined as an increase in platelet count to ≥ 50\*10\^9/L on any day from Day 2 to Day 7.

    Day 2 to Day 7

Secondary Outcomes (4)

  • Time to Achieve a Clinical Response

    Day 2 to Day 7

  • Maximum Platelet Count

    Day 2 to the end of the study (Day 63)

  • Duration of the Clinical Response

    Day 2 to the end of the study (Day 63)

  • Percentage of Participants With None, Minor, Mild, or Moderate Bleeding at Day 7

    Day 7

Study Arms (1)

Octagam 10% 1 g/kg/day

EXPERIMENTAL

Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.

Drug: Octagam 10%

Interventions

Octagam 10%DRUG

Octagam 10% was supplied as a ready-to-use solution in glass bottles.

Also known as: Human normal immunoglobulin
Octagam 10% 1 g/kg/day

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of Idiopathic Thrombocytopenic Purpura (ITP) according to standard criteria.
  • Platelet count ≤ 20 x 10\^9/L.

You may not qualify if:

  • Chronic refractory ITP patients.
  • Thrombocytopenia secondary to other diseases, or drug related thrombocytopenia.
  • Administration of IGIV, anti-D, or other platelet enhancing drugs within 30 days before enrollment.
  • Administration of thrombocyte concentrates within 72 hours before baseline.
  • Experimental treatment (eg, rituximab) within 3 months before enrollment.
  • Prophylactic preoperative treatment for elective splenectomy.
  • Severe liver or kidney disease.
  • Pregnant or nursing female.
  • History of hypersensitivity to blood or plasma derived products.
  • Emergency operation.
  • Live viral vaccination within the last month prior to study entry.
  • Known IgA deficiency and antibodies against IgA.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Octapharma for information

Vienna, Austria

Location

Related Publications (1)

  • Robak T, Mainau C, Pyringer B, Chojnowski K, Warzocha K, Dmoszynska A, Straub J, Imbach P. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam(R) 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9. doi: 10.1179/102453310X12719010991867.

    PMID: 20863431DERIVED

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

Results Point of Contact

Title
Michael Eppolito
Organization
Octapharma USA
michael.eppolito@octapharma.com
201 604-1155

Study Officials

  • Wolfgang Frenzel, MD

    Octapharma

    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

January 22, 2007

First Posted

January 24, 2007

Study Start

June 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

August 1, 2014

Results First Posted

May 8, 2014

Record last verified: 2014-07

Locations

AU(1)