Efficacy and Safety of IVIG-L in ITP Patients

NCT00151840 | Completed Phase 3

• 1 other identifier: KB98001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 6

Brief Summary

The efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, in patients with ITP will be assessed and compared with data obtained from literature.

Conditions

Purpura, Thrombocytopenic, Idiopathic

Keywords

Purpura, Thrombocytopenic, Idiopathic; ITP; Immunoglobulin, Intravenous

Outcome Measures

Primary Outcomes (2)

• The efficacy of IVIG-L

• The safety of IVIG-L

Secondary Outcomes (1)

• To compare data on efficacy and safety of IVIG-L with data obtained from literature

Interventions

IVIG-L DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic ITP with a platelet count of about 20x109/L and at high risk of bleeding
• Patients with chronic ITP with a platelet count of about 20x109/L, who have to undergo surgery
• A stable clinical situation (no activity of any other disease)
• Age at least 18 yrs
• The patient/legally acceptable representative has signed the consent form

You may not qualify if:

• The presence of another autoimmune disease related with thrombocytopenia such as systematic lupus erythematosus (SLE), rheumatoid arthritis (RA) or nephritis
• Patients with drug-induced thrombocytopenia or immunologic thrombocytopenia of infectious origin (in particular, Hepatitis, Epstein-Barr virus, Toxoplasma, HIV)
• Massive splenomegaly
• Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
• Having an ongoing progressive terminal disease, including HIV infection
• Known with allergic reactions against human plasma, plasma products or intravenous immunoglobulin
• Presence of conditions predisposing for bleeding: anaemia (hemoglobin \< 5.5 mmol/L), renal or urogenital disease, malignant disease (with the exception of basalioma, cervix carcinoma in situ), history of intracranial or aortic aneurysm, stroke, oeso-gastro-intestinal disorders with a bleeding potential, severe hypertension (diastole \> 110 mm Hg).
• Use of corticosteroids for an acute situation within 7 days before study entry. Patients using corticosteroids prophylactically can be included
• Splenectomy in the previous two weeks
• Renal insufficiency (plasma creatinine \> 115µmol/L)
• Pregnancy or lactation
• Known with insufficiency of coronary or cerebral circulation
• IgA deficiency and anti-IgA antibodies

Sponsors & Collaborators

• Prothya Biosolutions: lead

Study Sites (6)

Hematology Clinic, Medical University of Bialystok

Bialystok, 15-276, Poland

Location

Haematology Clinic, Medical University of Gdansk

Gdansk, 80-952, Poland

Location

Clinic of Haematology, Medical University of Lodz

Lodz, 93-509, Poland

Location

Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy

Warsaw, 00-909, Poland

Location

Institute of Haematology and Transfusiology

Warsaw, 00-957, Poland

Location

Haematology Clinic, Medical University of Warsaw

Warsaw, 02-097, Poland

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

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

Study Officials

• P FW Strengers, MD

  Prothya Biosolutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: October 1, 2001
• Study Completion: March 1, 2002
• Last Updated: January 31, 2006

Record last verified: 2006-01

Locations

PL (6)