Clinical trialNCT04264884
Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab
A study testing Daratumumab, run by Janssen Research & Development, LLC.
Trial summary
The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Daratumumab
- Type of treatment
- Injection or infusion
- 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
Official title: Daratumumab Subcutaneous Pre-approval Access Study
The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.
- Being tested
- Daratumumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaratumumabDrug
Daratumumab 1800 milligram (mg) will be administered as a fixed dose by subcutaneous (SC) injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264884
- Sponsor's protocol ID
- CR108780
- Other IDs
- 54767414MMY4031
- Status last verified
- Jul 2020
- First submitted
- 7 Feb 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daratumumab Subcutaneous Pre-approval Access Study
- ClinicalTrials.gov ID
- NCT04264884
- Acronym / sponsor ID
- CR108780
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- First posted
- 11 Feb 2020 (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 pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.
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 |
|---|---|---|
| DaratumumabDaratumumab 1800 milligram (mg) will be administered as a fixed dose by subcutaneous (SC) injection. | 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 7 Jul 2020.
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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
Questions about this trial
What is this clinical trial studying?
A study testing Daratumumab, 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 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 7 Jul 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 7 Jul 2020.