Hepatitis CNCT01715779
Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
An observational study of Hepatitis C, run by Novartis.
Trial summary
The objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (TEE) during participation in the GSK ENABLE clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Eltrombopag
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jun 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients under study are patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.
Who may be able to join
- Patients with portal vein thrombosis (PVT)
- Patients with deep vein thrombosis (DVT)
- Patients with pulmonary embolism (PE)
- Patients with myocardial infarction (MI)
- Patients with unstable angina
- Patients with transient ischemic attack (TIA)
- Patients with ischemic stroke
- Patients with other TEE including embolism, thrombosis, phlebitis, and thrombophlebitis at other locations
Who cannot join
- There are no exclusion criteria for this study
About this study
Official title: An Observational Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
The objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (TEE) during participation in the GSK ENABLE clinical trials.
Patients eligible for the study are patient who experienced a TEE during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period, information will be collected for the outcomes of interests: mortality, new TEE, hepatic decompensation, evaluation for liver transplant and result of evaluation, and liver transplantation.
All information will collected by medical record review.
- Conditions
- Hepatitis C
- Being tested
- Eltrombopag
- Keywords
- Liver transplantation, ENABLE, observational, mortality, Thromboembolic Events, Hepatic decompensation, Long-Term follow-up, TEE
- Medical subject headings
- Hepatitis C, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EltrombopagDrug
Eltrombopag exposure
| Study group | Role | What they receive |
|---|---|---|
| Patients who experienced a thromboembolic event | Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials. Receives: Drug: Eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Measured: The patients will be followed from 5 years from first occurrence of thromboembolic event.
New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Measured: The patients will be followed from 5 years from first occurrence of thromboembolic event.
Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Measured: The patients will be followed from 5 years from first occurrence of thromboembolic event.
Evaluation for liver transplant and result of evaluation.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Measured: The patients will be followed from 5 years from first occurrence of thromboembolic event.
Liver transplantation. Patients who experienced a Liver transplantation during study participation.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Measured: The patients will be followed from 5 years from first occurrence of thromboembolic event.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715779
- Sponsor's protocol ID
- 116951
- Other IDs
- WWE116951, EPI40685
- Status last verified
- Apr 2016
- First submitted
- 25 Oct 2012
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
- ClinicalTrials.gov ID
- NCT01715779
- Acronym / sponsor ID
- 116951
- Conditions
- Hepatitis C
- Keywords
- Liver transplantation, ENABLE, observational, mortality, Thromboembolic Events, Hepatic decompensation, Long-Term follow-up, TEE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 29 Oct 2012 (estimated)
- 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 objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (TEE) during participation in the GSK ENABLE clinical trials.
Patients eligible for the study are patient who experienced a TEE during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period, information will be collected for the outcomes of interests: mortality, new TEE, hepatic decompensation, evaluation for liver transplant and result of evaluation, and liver transplantation.
All information will collected by medical record review.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who experienced a thromboembolic event | – | Drug: EltrombopagPatients who experienced a thromboembolic event during participation in the ENABLE clinical trials. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients under study are patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.
Key inclusion criteria (8 listed)
- Patients with portal vein thrombosis (PVT)
- Patients with deep vein thrombosis (DVT)
- Patients with pulmonary embolism (PE)
- Patients with myocardial infarction (MI)
- Patients with unstable angina
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study
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 |
|---|---|---|
| EltrombopagEltrombopag exposure | Drug | Patients who experienced a thromboembolic event |
Primary outcome
Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.
Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation.
Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.
Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Evaluation for liver transplant and result of evaluation.
Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Liver transplantation. Patients who experienced a Liver transplantation during study participation.
Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
An observational study following patients who experienced a thromboembolic event (TEE) during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period. All information will collected by medical record review.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Novartis.
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 8 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: finished, as of the sponsor's last update on 8 Apr 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation. (time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.). 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 8 Apr 2016.