Idiopathic Thrombocytopenic Purpura (ITP)Phase 1NCT00571467
Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP
A Phase 1 study testing PRTX-100 (Staphylococcal protein A) in people with Idiopathic Thrombocytopenic Purpura (ITP), run by Protalex, Inc. at 7 sites in 2 countries.
Trial summary
The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Thrombocytopenic Purpura (ITP)
- What is being tested?
- PRTX-100 (Staphylococcal protein A)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2007to Mar 2009
- Phase
- Phase 1
- 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
- Diagnosis of chronic ITP > 4 months
- Mean platelet count <50 x 10^9/L for patients not receiving corticosteroids; or mean platelet count >=50 x 10^9/L for patients receiving stable dose of corticosteroids
Who cannot join
- Splenectomy within 45 days of screening
- Rituximab within 6 months prior to screening
- Cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening
- IVIG, WinRho or other anti-RhD within 30 days prior to screening
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia6 sites
Royal Brisbane
Brisbane, Queensland
Freemantle Hospital
Fremantle, Western Australia
Canberra Hospital
Garran, Australian Capital Territory
Monash Medical Centre
Melbourne, Victoria
Royal Perth Hospital
Perth, Western Australia
St. George Hospital
Sydney, New South Wales
About this study
Official title: An Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied.
Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100. A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. Patients will be followed for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet count(pharmacodynamics).
- Being tested
- PRTX-100 (Staphylococcal protein A)
- Keywords
- Autoimmune Diseases, Bleeding Disorders, Blood and Blood Disorders
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Autoimmune Diseases, Hemostatic Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRTX-100 (Staphylococcal protein A)Drug
Also called PRTX-100
4 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels:
- Cohort 1: 0.075 mcg/kg
- Cohort 2: 0.15 mcg/kg
- Cohort 3: 0.30 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| PRTX-100 (Staphylococcal protein A) | Experimental | Cohort 1: 0.075 mcg/kg
Cohort 2: 0.15 mcg/kg
Cohort 3: 0.30 mcg/kg Receives: Drug: PRTX-100 (Staphylococcal protein A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the overall safety of PRTX-100 during the 3 month study duration
Measured: 3 months
Secondary outcomes (3)
Characterize the pharmacokinetics of multiple doses of PRTX-100
Measured: over the first 35 days
Explore immunogenicity of multiple doses of PRTX-10
Measured: 3 months
Evaluate treatment effect on platelet count
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: Terminated due to recruitment not meeting expectations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Thrombocytopenic Purpura (ITP)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protalex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Bernton, MD, Study director, Protalex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571467
- Sponsor's protocol ID
- PRTX-100A-201
- Status last verified
- Jul 2018
- First submitted
- 10 Dec 2007
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT00571467
- Acronym / sponsor ID
- PRTX-100A-201
- Keywords
- Autoimmune Diseases, Bleeding Disorders, Blood and Blood Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to recruitment not meeting expectations.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Protalex, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 12 Dec 2007 (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 primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied.
Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100. A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. Patients will be followed for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet count(pharmacodynamics).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRTX-100 (Staphylococcal protein A) | Experimental | Drug: PRTX-100 (Staphylococcal protein A)Cohort 1: 0.075 mcg/kg Cohort 2: 0.15 mcg/kg Cohort 3: 0.30 mcg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic ITP > 4 months
- Mean platelet count <50 x 10^9/L for patients not receiving corticosteroids; or mean platelet count >=50 x 10^9/L for patients receiving stable dose of corticosteroids
Key exclusion criteria (4 listed)
- Splenectomy within 45 days of screening
- Rituximab within 6 months prior to screening
- Cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening
- IVIG, WinRho or other anti-RhD within 30 days prior to screening
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 |
|---|---|---|
| PRTX-100 (Staphylococcal protein A)Also: PRTX-1004 weekly IV (in the vein) doses of 1 of the 3 following PRTX-100 dose levels: * Cohort 1: 0.075 mcg/kg * Cohort 2: 0.15 mcg/kg * Cohort 3: 0.30 mcg/kg | Drug | PRTX-100 (Staphylococcal protein A) |
Primary outcome
Evaluate the overall safety of PRTX-100 during the 3 month study duration
Time frame: 3 months
3 secondary outcomes
Characterize the pharmacokinetics of multiple doses of PRTX-100
Time frame: over the first 35 days
Explore immunogenicity of multiple doses of PRTX-10
Time frame: 3 months
Evaluate treatment effect on platelet count
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Terminated due to recruitment not meeting expectations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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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.
Edward Bernton, MD study director
Protalex, Inc.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRTX-100 (Staphylococcal protein A) in people with Idiopathic Thrombocytopenic Purpura (ITP), run by Protalex, Inc. at 7 sites in 2 countries.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, New Zealand. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Terminated due to recruitment not meeting expectations.). Results are not available in the source record.
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?
Evaluate the overall safety of PRTX-100 during the 3 month study duration (time frame: 3 months). 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 20 Jul 2018.