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

Purpose

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%.

Condition	Intervention	Phase
Idiopathic Thrombocytopenic Purpura	Drug: Octagam 10%	Phase III

Genetics Home Reference related topics:

hemophilia thrombotic thrombocytopenic purpura

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further study details as provided by Octapharma:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	116
Study Start Date:	January 2006
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426270

Contacts


Contact: Barbara Pyringer	+ 43 1 610 32 1202	barbara.pyringer@octapharma.com

Locations


Austria
	Contact Octapharma for information	Recruiting
	Vienna, Austria
	Contact: Barbara Pyringer + 43 1 610 32 202 barbara.pyringer@octapharma.com

Sponsors and Collaborators

Octapharma

Investigators


Study Director:	Wolfgang Frenzel, M.D.	Octapharma

More Information

Responsible Party:	Octapharma ( Barbara Pyringer )
Study ID Numbers:	GAM10-02
First Received:	January 22, 2007
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00426270
Health Authority:	United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institut; Czech Republic: State Institute for Drug Control; Austria: Agency for Health and Food Safety; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Purpura

Autoimmune Diseases

Hematologic Diseases

Blood Coagulation Disorders

Blood Platelet Disorders

Hemostatic Disorders

Purpura, Thrombocytopenic

Signs and Symptoms

Thrombocytopathy

Thrombocytopenia

Hemorrhagic Disorders

Immunoglobulins, Intravenous

Thrombocytopenic purpura, autoimmune

Purpura, Thrombocytopenic, Idiopathic

Rho(D) Immune Globulin

Immunoglobulins

Additional relevant MeSH terms:

Skin Manifestations

Immunologic Factors

Immune System Diseases

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Octapharma
Information provided by:	Octapharma
ClinicalTrials.gov Identifier:	NCT00426270