Aplastic AnemiaNCT03906318
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia
A study testing Iticitinib in people with Aplastic Anemia, run by Incyte Corporation.
Trial summary
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aplastic Anemia
- What is being tested?
- Iticitinib
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- -
About this study
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia
- Conditions
- Aplastic Anemia
- Being tested
- Iticitinib
- Medical subject headings
- Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IticitinibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aplastic AnemiaStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Forbes Satter, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906318
- Sponsor's protocol ID
- I-39110-18-05
- Status last verified
- Sep 2022
- First submitted
- 4 Apr 2019
- Last updated
- 30 Sep 2022
- Results posted
- No
Publications
Rosenberg JM, Peters JM, Hughes T, Lareau CA, Ludwig LS, Massoth LR, Austin-Tse C, Rehm HL, Bryson B, Chen YB, Regev A, Shalek AK, Fortune SM, Sykes DB. JAK inhibition in a patient with a STAT1 gain-of-function variant reveals STAT1 dysregulation as a common feature of aplastic anemia. Med. 2022 Jan 14;3(1):42-57.e5. doi: 10.1016/j.medj.2021.12.003.
PubMed 35590143
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia
- ClinicalTrials.gov ID
- NCT03906318
- Acronym / sponsor ID
- I-39110-18-05
- Conditions
- Aplastic Anemia
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- First posted
- 8 Apr 2019 (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.
Expanded Access Use of Itacitinib to Treat a Single Patient With Aplastic Anemia
Study design
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Iticitinib | 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 30 Sep 2022.
- Derived from this study: PubMed 35590143Rosenberg JM, Peters JM, Hughes T, Lareau CA, Ludwig LS, Massoth LR, Austin-Tse C, Rehm HL, Bryson B, Chen YB, Regev A, Shalek AK, Fortune SM, Sykes DB. JAK inhibition in a patient with a STAT1 gain-of-function variant reveals STAT1 dysregulation as a common feature of aplastic anemia. Med. 2022 Jan 14;3(1):42-57.e5. doi: 10.1016/j.medj.2021.12.003.
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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.
Lisa Forbes Satter, MD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Iticitinib in people with Aplastic Anemia, run by Incyte Corporation.
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 1 inclusion and 1 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 30 Sep 2022. 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?
On the ClinicalTrials.gov record for NCT03906318, which also lists 1 linked publication.
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 30 Sep 2022.