Efficacy and Safety of IVIG-L in ITP Patients
This study has been completed.
Sponsor:
Sanquin
Information provided by:
Sanquin
ClinicalTrials.gov Identifier:
NCT00151840
First received: September 8, 2005
Last updated: January 30, 2006
Last verified: January 2006
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Purpura, Thrombocytopenic, Idiopathic |
Drug: IVIG-L |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients |
Resource links provided by NLM:
Further study details as provided by Sanquin:
Primary Outcome Measures:
- The efficacy of IVIG-L
- The safety of IVIG-L
Secondary Outcome Measures:
- To compare data on efficacy and safety of IVIG-L with data obtained from literature
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2001 |
| Estimated Study Completion Date: | March 2002 |
Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service (FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of intravenous immunoglobulin simplifies infusion, eliminates possible mistakes in the reconstitution with water for injection and reduces space requirements in storage.
In addition to donor selection and screening, several procedures have been included in the production process to improve viral safety.
In this clinical trial, the efficacy and safety of IVIG-L in patients with ITP will be assessed and compared with data obtained from literature. IVIG-L will also be studied in patients with hypogammaglobulinemia.The results from both studies will be used for an application for marketing authorisation of IVIG-L in Finland and the Netherlands.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151840
Locations
| Poland | |
| Hematology Clinic, Medical University of Bialystok | |
| Bialystok, Poland, 15-276 | |
| Haematology Clinic, Medical University of Gdansk | |
| Gdansk, Poland, 80-952 | |
| Clinic of Haematology, Medical University of Lodz | |
| Lodz, Poland, 93-509 | |
| Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy | |
| Warsaw, Poland, 00-909 | |
| Haematology Clinic, Medical University of Warsaw | |
| Warsaw, Poland, 02-097 | |
| Institute of Haematology and Transfusiology | |
| Warsaw, Poland, 00-957 | |
Sponsors and Collaborators
Sanquin
Investigators
| Study Director: | P FW Strengers, MD | Sanquin |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00151840 History of Changes |
| Other Study ID Numbers: | KB98001 |
| Study First Received: | September 8, 2005 |
| Last Updated: | January 30, 2006 |
| Health Authority: | Poland: Ministry of Health |
Keywords provided by Sanquin:
|
Purpura, Thrombocytopenic, Idiopathic ITP Immunoglobulin, Intravenous |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia |
Blood Platelet Disorders Immune System Diseases Hemorrhagic Disorders Autoimmune Diseases Immunoglobulins Antibodies Immunoglobulins, Intravenous Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013