Skip to main content
OpenTrials
Completed

NCT Number: NCT00426270

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

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%.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immune Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact Octapharma for information

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Treatment and study plan

Octagam 10%

Drug

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

Other names: Human normal immunoglobulin

Primary outcomes

  1. Percentage of Participants With a Clinical Response

    Time frame: Day 2 to Day 7

    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.

Secondary outcomes

  1. Time to Achieve a Clinical Response

    Time frame: Day 2 to Day 7

    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.

  2. Maximum Platelet Count

    Time frame: Day 2 to the end of the study (Day 63)

    Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. The maximum measured platelet count is reported.

  3. Duration of the Clinical Response

    Time frame: Day 2 to the end of the study (Day 63)

    The duration of the clinical response was the number of days that the platelet count remained ≥ 50*10^9/L. Platelet count was assessed on Days 2 through 7 and on Days 14, 21, and 63. A conservative method was used to calculate the duration of the clinical response. For example, if the platelet count was ≥ 50*10^9/L on Day 7 and dropped below 50*10^9/L at Day 14, Day 7 was used as the last day to calculate the duration of the clinical response. The same procedure was used if the platelet count dropped below 50*10^9/L at Day 21 from Day 14 or Day 63 from Day 21.

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

    Time frame: Day 7

    The investigator evaluated the severity of bleeding using the following rating scale: None (definitely no haemorrhage of any kind), Minor (few petechiae [≤ 100 total] and/or ≤ 5 small bruises [≤ 3 cm diameter], no mucosal bleeding), Mild (many petechiae [> 100 total] and/or > 5 large bruises [> 3 cm diameter], no mucosal bleeding), Moderate (overt mucosal bleeding [epistaxis, gum bleeding, oropharyngeal blood blisters, menorrhagia, gastrointestinal bleeding, etc] that does not require immediate medical attention or intervention).

Sponsors and collaborators

Lead sponsor

Octapharma

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jan 24, 2007
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.