Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

This study has been completed.

Sponsor:

Information provided by:

Octapharma

ClinicalTrials.gov Identifier:

NCT00426270

First received: January 22, 2007

Last updated: December 5, 2008

Last verified: December 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 22, 2007

Last Updated Date

December 5, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Increase in platelet count to more 50 x 10 to the 9th /L within 7 days after treatment [ Time Frame: 7 days after treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00426270 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

time to reach an increase in platelet count to more than 50 x 10 to the 9th / L [ Time Frame: 7 days ] [ Designated as safety issue: No ]
maximum platelet level [ Time Frame: 63 days ] [ Designated as safety issue: No ]
duration of platelet response [ Time Frame: 63 days ] [ Designated as safety issue: No ]
assessment of the severity of hemorrhages [ Time Frame: 21 days ] [ Designated as safety issue: No ]
tolerability [ Time Frame: 63 days ] [ Designated as safety issue: Yes ]
adverse event monitoring [ Time Frame: 63 days ] [ Designated as safety issue: Yes ]
assessment of viral safety [ Time Frame: 63 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

Official Title ^ICMJE

Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults

Brief Summary

Octagam is a double virus inactivated human normal immunoglobulin(IGIV) solution of intravenous administration. Octagam 5% is currently registered in about 60 countries. This study will evaluate 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%.

Detailed Description

The primary objective of the study is to investigate the efficacy of Octagam® 10% in correcting the platelet count.The blood count as well as laboratory chemistry will be checked repeatedly up to day 21.

The secondary objective of the study is to investigate the safety of Octagam® 10%. Safety will be assessed by monitoring of vital signs, the evaluation of adverse event (AE) recordings and laboratory parameters, and by viral safety testing.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Idiopathic Thrombocytopenic Purpura

Intervention ^ICMJE

Drug: Octagam 10%

1g/kg/day of Octagam 10% will be infused ove 2 consecutive days

Study Arm (s)

Not Provided

Publications *

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® 10%) in patients with immune thrombocytopenia. Hematology. 2010 Oct;15(5):351-9.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

116

Completion Date

November 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Key Inclusion Criteria:

Diagnosis of ITP according to standard criteria
Platelet count of less than or equal to 20 x 10 to the 9th/L

Key Exclusion Criteria:

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(e.g.,Rituximab),within 3 months before enrollment
Prophylactic preoperative treatment for elective splenectomy
Severe liver or kidney disease
pregnant or nursing woman
History of hypersensitivity to blood or plasma derived products
Emergency operation
Live viral vaccination within the last month prior to study entry

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT00426270

Other Study ID Numbers ^ICMJE

GAM10-02

Has Data Monitoring Committee

Yes

Responsible Party

Barbara Pyringer, Octapharma

Study Sponsor ^ICMJE

Octapharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Wolfgang Frenzel, M.D.

Octapharma

Information Provided By

Octapharma

Verification Date

December 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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