Purpura, Thrombocytopenic, IdiopathicPhase 3NCT00151840
Efficacy and Safety of IVIG-L in ITP Patients
A Phase 3 study testing IVIG-L in people with Purpura, Thrombocytopenic, Idiopathic, run by Prothya Biosolutions at 6 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Purpura, Thrombocytopenic, Idiopathic
- What is being tested?
- IVIG-L
- How many people
- 20 participants
- Where
- 6 sitesPoland
- Study dates
- Oct 2001to Mar 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Poland6 sites
Hematology Clinic, Medical University of Bialystok
Bialystok, 15-276
Haematology Clinic, Medical University of Gdansk
Gdansk, 80-952
Clinic of Haematology, Medical University of Lodz
Lodz, 93-509
Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy
Warsaw, 00-909
Institute of Haematology and Transfusiology
Warsaw, 00-957
Haematology Clinic, Medical University of Warsaw
Warsaw, 02-097
About this study
Official title: Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients
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.
Read the detailed description
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.
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Being tested
- IVIG-L
- Keywords
- Purpura, Thrombocytopenic, Idiopathic, ITP, Immunoglobulin, Intravenous
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVIG-LDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startOct 2001
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Purpura, Thrombocytopenic, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Prothya Biosolutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- P FW Strengers, MD, Study director, Prothya Biosolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151840
- Sponsor's protocol ID
- KB98001
- Status last verified
- Jan 2006
- First submitted
- 8 Sep 2005
- Last updated
- 31 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients
- ClinicalTrials.gov ID
- NCT00151840
- Acronym / sponsor ID
- KB98001
- Conditions
- Purpura, Thrombocytopenic, Idiopathic
- Keywords
- Purpura, Thrombocytopenic, Idiopathic, ITP, Immunoglobulin, Intravenous
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Prothya BiosolutionsIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Study completion
- Mar 2002
- First posted
- 9 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVIG-L | Drug | – |
Primary outcome
The efficacy of IVIG-L
The safety of IVIG-L
1 secondary outcome
To compare data on efficacy and safety of IVIG-L with data obtained from literature
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
P FW Strengers, MD study director
Prothya Biosolutions
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IVIG-L in people with Purpura, Thrombocytopenic, Idiopathic, run by Prothya Biosolutions at 6 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of IVIG-L. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2006.