Chikungunya VirusTRUENCT02305732
A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
An observational study of Chikungunya Virus and Dengue Virus, run by Cerus Corporation at 8 sites in Puerto Rico.
Trial summary
The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chikungunya Virus, Dengue Virus
- What is being tested?
- INTERCEPT Platelets
- How many people
- 90 participants
- Where
- 8 sitesPuerto Rico
- Study dates
- Mar 2015to May 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients requiring a platelet transfusion.
Who may be able to join
- Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)
- Patient population as defined by each Investigator and their institutional review board (IRB).
- Patient provides written informed consent
Who cannot join
- Documented allergy to psoralens
- Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.
- Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Puerto Rico8 sites
Hospital General Menonita de Aibonito
Aibonito, 00705
Hospital General Menonita de Caguas
Caguas, 00725
Hospital General Menonita de Cayey
Cayey
Center Hospital Manati
Manati, 00674
Hospital San Lucas Ponce
Ponce, 00733
Hospital La Concepcion San German
San German, 00683
Centro Cardiovascular de Puerto Rico and the Caribbean
San Juan, 00683
Veteran Administration
San Juan, 00921
About this study
The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).
The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.
Read the detailed description
Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).
- Conditions
- Chikungunya Virus, Dengue Virus
- Being tested
- INTERCEPT Platelets
- Keywords
- Chikungunya virus, CHIKV, Dengue virus, DENV, pathogen inactivation, platelets, Puerto Rico
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERCEPT PlateletsBiological
INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing.
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.
INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines.
Subjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study.
Measured: 1 year
The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection
Measured: 1 year
The Proportion of Patients With Any Transfusion Reactions
Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.
Measured: 1 year
The Proportion of Patients With Any Unrelated Adverse Event
Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.
Measured: 1 year
The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event
Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.
Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.
""1 Transfusion = 1 Intercept Platelet Component".
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chikungunya VirusStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American National Red Cross
- Responsible party
- Sponsor
- Investigators
- Susan L Stramer, PhD, Principal investigator, American National Red Cross
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305732
- Sponsor's protocol ID
- CLI 00108
- Acronym
- TRUE
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2014
- Last updated
- 30 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open Label, Treatment Use Study of Patient Safety Following Transfusion of INTERCEPT Platelet Components
- ClinicalTrials.gov ID
- NCT02305732
- Acronym / sponsor ID
- TRUE / CLI 00108
- Conditions
- Chikungunya Virus, Dengue Virus
- Keywords
- Chikungunya virus, CHIKV, Dengue virus, DENV, pathogen inactivation, platelets, Puerto Rico
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Collaborators
- American National Red Cross
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Posted 30 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The rationale for a Treatment Use Investigational Device Exemption (IDE) of INTERCEPT PCs is to address current gaps in platelet transfusion safety in selected geographic regions. The objective is to provide access to INTERCEPT PCs for patients who might be at risk of transfusion-transmitted infection (TTI) due to Chikungunya virus (CHIKV) and Dengue virus (DENV) in regions in which a substantial proportion of the population has been infected or is at risk of infection by these pathogens (Petersen 2014); and the risk of asymptomatic infection among qualified blood donors is recognized (Stramer 2012, Adda 2014).
The study is designed as a prospective, open label, multi-center, observational study to evaluate the safety and efficacy of INTERCEPT platelet components.
Detailed description
Upon written informed consent, patients will be transfused with study PCs according to local practices. Each patient will be supported with platelets as clinically indicated in a manner that is consistent with the local standard of care. The study will be conducted in two phases. During the pilot phase, patients will sign informed consent to have study data collected following transfusion with conventional PCs. The objective of the pilot phase is to evaluate study logistics and data collection methods. During the INTERCEPT Treatment Use phase, patients will sign informed consent to receive INTERCEPT PCs, provide blood samples, and collect study data (demographics, transfusion data, and safety data).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients requiring a platelet transfusion.
Key inclusion criteria (3 listed)
- Patients with a serious disease expected to require or requiring a transfusion of platelet component(s)
- Patient population as defined by each Investigator and their institutional review board (IRB).
- Patient provides written informed consent
Key exclusion criteria (3 listed)
- Documented allergy to psoralens
- Neonatal patients treated with phototherapy devices that emit wavelengths less than 425 nm due to the potential for erythema resulting from interaction between ultraviolet light and amotosalen.
- Pregnant women in their third trimester of pregnancy (due to possibility the neonate may need bilirubin light treatment after birth).
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 |
|---|---|---|
| INTERCEPT PlateletsINTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing. | Biological | – |
Primary outcome
The Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets.
Time frame: 1 year
INTERCEPT platelet components (PCs) manufactured for this study are leukocyte reduced apheresis PCs processed using the INTERCEPT Blood System (IBS) for platelets. The IBS for platelets is a Class III medical device approved by the FDA for the ex-vivo preparation and storage of pathogen reduced apheresis PCs. The system is used to inactivate a broad range of pathogens, including viruses, bacteria, and protozoan parasites as well as contaminating donor leukocytes. Post-manufacturing, INTERCEPT PCs are either transfused or stored according to blood center standard operating procedures, US FDA, and AABB Guidelines. Subjects enrolled in this study are transfused with INTERCEPT PCs as dictated by the treating physician. One platelet component was treated as one platelet transfusion for the purpose of data analysis in this study.
The Proportion of Patients With a Confirmed Case of Transfusion-transmitted Chikungunya Virus or Dengue Infection
Time frame: 1 year
The Proportion of Patients With Any Transfusion Reactions
Time frame: 1 year
Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused.
The Proportion of Patients With Any Unrelated Adverse Event
Time frame: 1 year
Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused.
The Proportion of Transfused INTERCEPT Platelet Components Associated With Any Transfusion Reactions and/or Unrelated Adverse Event
Time frame: 1 year
Transfusion reactions are defined as adverse events assessed as possibly, likely/probably or certainly related to the INTERCEPT platelet component transfused. Unrelated adverse events are defined as adverse events unrelated to the INTERCEPT platelet component transfused. ""1 Transfusion = 1 Intercept Platelet Component".
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Susan L Stramer, PhD principal investigator
American National Red Cross
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chikungunya Virus and Dengue Virus, run by Cerus Corporation at 8 sites in Puerto Rico.
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 3 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: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 30 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Proportion of Transfused INTERCEPT Platelet Components With a Post-treatment Platelet Dose ≥ 3.0×10^11 Platelets. (time frame: 1 year). The study lists 5 primary outcomes in all. 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 30 Oct 2018.