H7N9 Subtype of Influenza A VirusNCT03834376
Pre-Approval Access to Pimodivir for the Treatment of Patients With H7N9 Influenza A Infection
A study testing Pimodivir in people with H7N9 Subtype of Influenza A Virus, run by Janssen Research & Development, LLC.
Trial summary
The purpose of this program is to provide pre-approval access to pimodivir for the treatment of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision for therapeutic use of an investigational product prior to its marketing authorization. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- H7N9 Subtype of Influenza A Virus
- What is being tested?
- Pimodivir
- 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 13 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- The patient has an H7N9 Influenza A infection
- The patient has no known severe hepatic impairment
Who cannot join
- Any other Influenza A sub-strains other than H7N9
About this study
Official title: Pimodivir (JNJ-63623872) Pre Approval Access_Single Patient Access (SPR) for Patients Diagnosed With H7N9 Influenza A Infection
The purpose of this program is to provide pre-approval access to pimodivir for the treatment of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision for therapeutic use of an investigational product prior to its marketing authorization. Such access may be considered for eligible patients with serious/life-threatening diseases or conditions, where alternative treatments do not exist or have been exhausted.
- Conditions
- H7N9 Subtype of Influenza A Virus
- Being tested
- Pimodivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimodivirDrug
Also called JNJ-63623872
Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H7N9 Subtype of Influenza A VirusStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834376
- Sponsor's protocol ID
- CR108461
- Other IDs
- 63623872FLZ4001
- Status last verified
- Oct 2020
- First submitted
- 5 Feb 2019
- Last updated
- 28 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pimodivir (JNJ-63623872) Pre Approval Access_Single Patient Access (SPR) for Patients Diagnosed With H7N9 Influenza A Infection
- ClinicalTrials.gov ID
- NCT03834376
- Acronym / sponsor ID
- CR108461
- Conditions
- H7N9 Subtype of Influenza A Virus
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- First posted
- 8 Feb 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.
The purpose of this program is to provide pre-approval access to pimodivir for the treatment of a patient(s) with H7N9 influenza A infection. Pre-approval access pertains to provision for therapeutic use of an investigational product prior to its marketing authorization. Such access may be considered for eligible patients with serious/life-threatening diseases or conditions, where alternative treatments do not exist or have been exhausted.
Study design
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The patient has an H7N9 Influenza A infection
- The patient has no known severe hepatic impairment
Key exclusion criteria (1 listed)
- Any other Influenza A sub-strains other than H7N9
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 |
|---|---|---|
| PimodivirAlso: JNJ-63623872Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days. | 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 28 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Pimodivir in people with H7N9 Subtype of Influenza A Virus, run by Janssen Research & Development, LLC.
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 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 28 Oct 2020. 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 28 Oct 2020.