Immune Thrombocytopenic PurpuraNCT03363334
Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP
A study testing Fostamatinib disodium 100 mg and Fostamatinib disodium 150 mg in people with Immune Thrombocytopenic Purpura, run by Rigel Pharmaceuticals.
Trial summary
C-935788-055 is an open-label, multi-center, expanded access (EAP) study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Thrombocytopenic Purpura
- What is being tested?
- Fostamatinib disodium 100 mg and Fostamatinib disodium 150 mg
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Adult, Older adult
Who may be able to join
- Adult patient with chronic or persistent ITP.
- Must have failed or are unable to receive standard of care treatments for ITP.
- Must have at least two platelet counts < 30,000/µL during the last 2 months prior to screen date.
Who cannot join
- ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
- Subject has uncontrolled or poorly controlled hypertension.
- Any of the following laboratory abnormalities: neutrophil count of < 1,500/µL, or transaminase levels (ALT, AST) > 1.5x ULN, total bilirubin > 2.0 mg/dL.
- Active HBV or HCV infection.
- Current or recent enrollment in an investigational drug or device study.
About this study
Official title: Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)
C-935788-055 is an open-label, multi-center, expanded access (EAP) study.
Read the detailed description
The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.
- Conditions
- Immune Thrombocytopenic Purpura
- Being tested
- Fostamatinib disodium 100 mg, Fostamatinib disodium 150 mg
- Keywords
- ITP, Immune Thrombocytopenia
- 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.
Fostamatinib disodium 100 mgDrug
Also called Fostamatinib, R935788, R788
Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)
Fostamatinib disodium 150 mgDrug
Also called Fostamatinib, R935788, R788
Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Thrombocytopenic PurpuraStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne-Marie Duliege, M.D., Study director, Rigel Pharmaceuticals, Inc., Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03363334
- Sponsor's protocol ID
- C-935788-055
- Status last verified
- Jun 2018
- First submitted
- 28 Nov 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)
- ClinicalTrials.gov ID
- NCT03363334
- Acronym / sponsor ID
- C-935788-055
- Conditions
- Immune Thrombocytopenic Purpura
- Keywords
- ITP, Immune Thrombocytopenia
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 6 Dec 2017 (actual)
- 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.
C-935788-055 is an open-label, multi-center, expanded access (EAP) study.
Detailed description
The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient with chronic or persistent ITP.
- Must have failed or are unable to receive standard of care treatments for ITP.
- Must have at least two platelet counts < 30,000/µL during the last 2 months prior to screen date.
Key exclusion criteria (5 listed)
- ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
- Subject has uncontrolled or poorly controlled hypertension.
- Any of the following laboratory abnormalities: neutrophil count of < 1,500/µL, or transaminase levels (ALT, AST) > 1.5x ULN, total bilirubin > 2.0 mg/dL.
- Active HBV or HCV infection.
- Current or recent enrollment in an investigational drug or device study.
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 |
|---|---|---|
| Fostamatinib disodium 100 mgAlso: Fostamatinib, R935788, R788Fostamatinib Disodium tablet 100 mg PO bid (morning and evening) | Drug | – |
| Fostamatinib disodium 150 mgAlso: Fostamatinib, R935788, R788Fostamatinib Disodium tablet 150 mg PO bid (morning and evening) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 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.
Anne-Marie Duliege, M.D. study director
Rigel Pharmaceuticals, Inc., Chief Medical Officer
Questions about this trial
What is this clinical trial studying?
A study testing Fostamatinib disodium 100 mg and Fostamatinib disodium 150 mg in people with Immune Thrombocytopenic Purpura, run by Rigel Pharmaceuticals.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
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.
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 1 Aug 2018.