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

NCT ID: NCT00426270

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-09-30

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%.

Detailed Description

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

The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory parameters, and by viral safety testing.

Conditions

Immune Thrombocytopenic Purpura

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Octagam 10% 1 g/kg/day

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

Group Type: EXPERIMENTAL

Octagam 10%

Intervention Type: DRUG

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

Interventions

Octagam 10%

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

Intervention Type: DRUG

Other Intervention Names

Human normal immunoglobulin

Eligibility Criteria

Inclusion Criteria

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

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 (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Octapharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolfgang Frenzel, MD

Role: STUDY_DIRECTOR

Octapharma

Locations

Contact Octapharma for information

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: DERIVED

PMID: 20863431 (View on PubMed)

Other Identifiers

GAM10-02

Identifier Type: -

Identifier Source: org_study_id