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

Information source: Octapharma
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Thrombocytopenic Purpura

Intervention: Octagam 10% (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Octapharma

Official(s) and/or principal investigator(s):
Wolfgang Frenzel, M.D., Study Director, Affiliation: Octapharma

Overall contact:
Barbara Pyringer, Phone: + 43 1 610 32 1202, Email: barbara.pyringer@octapharma.com

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%.

Clinical Details

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

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

Primary outcome: Increase in platelet count to more 50 x 10 to the 9th /L within 7 days after treatment

Secondary outcome:

time to reach an increase in platelet count to more than 50 x 10 to the 9th / L

maximum platelet level

duration of platelet response

assessment of the severity of hemorrhages

tolerability

adverse event monitoring

assessment of viral safety

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Barbara Pyringer, Phone: + 43 1 610 32 1202, Email: barbara.pyringer@octapharma.com

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

Starting date: January 2006
Ending date: October 2008
Last updated: April 23, 2008

Page last updated: November 03, 2008

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