Ebola Virus DiseasePhase 2BCV EBOVNCT04268966
An Open-Label Study , Safety and Tolerability of Brincidofovir for Post Exposure Prophylaxis of Ebola
A Phase 2 study testing Brincidofovir in people with Ebola Virus Disease, run by Jazz Pharmaceuticals.
Trial summary
The purpose of this study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Ebola Virus Disease
- What is being tested?
- Brincidofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 2
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals have high-risk exposure to Ebola Virus based on CDC definitions
- Must be able to ingest, absorb and tolerate oral medication
- As appropriate, must be willing to use adequate methods of contraception during the study and at least 6 months after their last dose of BCV
Who cannot join
- -
About this study
Official title: An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease
The purpose of this study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease.
Read the detailed description
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD
- Conditions
- Ebola Virus Disease
- Being tested
- Brincidofovir
- Medical subject headings
- Hemorrhagic Fever, Ebola
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrincidofovirDrug
Also called CMX001
| Study group | Role | What they receive |
|---|---|---|
| CMX001 | Experimental | Initial dose of 200mg followed by 4 doses of 100mg Receives: Drug: Brincidofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD
Measured: 8 weeks
Secondary outcomes (1)
To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study startOct 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ebola Virus DiseaseStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04268966
- Sponsor's protocol ID
- CMX001-206
- Acronym
- BCV EBOV
- Status last verified
- Feb 2020
- First submitted
- 12 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Study of the Safety and Tolerability of Brincidofovir (CMX001) for Post-Exposure Prophylaxis of Ebola Virus Disease
- ClinicalTrials.gov ID
- NCT04268966
- Acronym / sponsor ID
- BCV EBOV / CMX001-206
- Conditions
- Ebola Virus Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Food and Drug Administration (FDA)
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 13 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 study is to determine how safe and tolerable Brincidofovir (BCV) is when given for post exposure prophylaxis of Ebola virus disease.
Detailed description
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CMX001 | Experimental | Drug: BrincidofovirInitial dose of 200mg followed by 4 doses of 100mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals have high-risk exposure to Ebola Virus based on CDC definitions
- Must be able to ingest, absorb and tolerate oral medication
- As appropriate, must be willing to use adequate methods of contraception during the study and at least 6 months after their last dose of BCV
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 |
|---|---|---|
| BrincidofovirAlso: CMX001 | Drug | CMX001 |
Primary outcome
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD
Time frame: 8 weeks
1 secondary outcome
To assess the effect of BCV treatment on development of EVD in subjects through 21 days post-initiation of BCV therapy
Time frame: 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 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 Phase 2 study testing Brincidofovir in people with Ebola Virus Disease, run by Jazz 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 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: withdrawn, as of the sponsor's last update on 26 Feb 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
The primary objective of this study is to evaluate the safety and tolerability of BCV when administered for post-exposure prophylaxis of EVD (time frame: 8 weeks). 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 26 Feb 2020.