HepatitisNCT02368522
Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe (CMPASS-EU)
An observational study of Hepatitis, run by Bristol-Myers Squibb at 1 site in Germany.
Trial summary
The study aims to collect information on the current treatment patterns for Hepatitis C in participating countries. There is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis
- How many people
- 920 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Feb 2017
- 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: Patients from private practices and outpatients units in hospitals
Who may be able to join
- Adult (≥18 years at inclusion)
- Diagnosed with a chronic hepatitis C infection
- Whose physician has already decided to initiate a new HCV treatment or a new daclatasvir-containing regimen
- Informed consent to participate in the study
Who cannot join
- Participation in a clinical trial or an early access program for HCV therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe
The study aims to collect information on the current treatment patterns for Hepatitis C in participating countries. There is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on effectiveness and safety of the treatment. Additional analysis will differentiate between selected subpopulations.
- Conditions
- Hepatitis
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with and without exposure | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify effectiveness of daclatasvir (DCV) containing regimen overall and in subgroups (GT1, non GT1 and cirrhotic patients) by measuring sustained virologic response (SVR12)
SVR12 defined as a documented undetectable viral load on or after week 12 following the end of treatment
Measured: Upto week 12 after the end of HCV treatment (SVR12)
Secondary outcomes (6)
SVR12 in patients treated with DCV-containing regimens in real-life by treatment regimen, genotype, cirrhosis stage, HCV-treatment experience, HIV coinfection, and previous LTx (if present)
Measured: Upto week 12 after the end of HCV treatment (SVR12)
Proportion of patients on DCV-containing regimens achieving SVR12 in real-life compared with SVR12 rates in clinical trials
Measured: Upto week 12 after the end of HCV treatment (SVR12)
Safety of DCV-containing regimens in real-life measured by the incidence of (S)AEs and the incidence leading to treatment discontinuation
Measured: Until completion of study
Demographic and clinical characteristics and treatment patterns of patients starting a new HCV treatment regimen (with or without DCV), overall and by treatment regimen,GT,cirrhosis stage,HCV-treatment experience,HIV co-infection,and previous LTx
Previous LTx (if present)
Measured: Baseline (single assessment)
Comparison of demographic and clinical characteristics of patients starting a new HCV treatment regimen (with or without DCV) by treatment regimen and to identify factors associated with the initiation of different regimens
Measured: Baseline (single assessment)
SVR 24 in patients treated with DCV-containing regimens in real-life clinical care, change of Child-Pugh Score and Metavir score as well as change of patient related outcomes (EQ-5D and SF-36 questionnaires measuring quality of life)
Metavir score (liver function and histology)
Measured: Upto week 24 after the end of HCV treatment (SVR24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatitisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368522
- Sponsor's protocol ID
- AI444-259
- Status last verified
- Feb 2017
- First submitted
- 12 Feb 2015
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Utilization of Antiviral Therapies in Hepatitis C and Effectiveness of Daclatasvir-containing Regimens in Real-life Clinical Care in Europe
- ClinicalTrials.gov ID
- NCT02368522
- Acronym / sponsor ID
- AI444-259
- Conditions
- Hepatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 23 Feb 2015 (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 study aims to collect information on the current treatment patterns for Hepatitis C in participating countries. There is also a focus on patients receiving a daclatasvir-containing treatment regimen who will be followed prospectively for 12 months after treatment initiation to collect real-world data on effectiveness and safety of the treatment. Additional analysis will differentiate between selected subpopulations.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with and without exposure | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from private practices and outpatients units in hospitals
Key inclusion criteria (4 listed)
- Adult (≥18 years at inclusion)
- Diagnosed with a chronic hepatitis C infection
- Whose physician has already decided to initiate a new HCV treatment or a new daclatasvir-containing regimen
- Informed consent to participate in the study
Key exclusion criteria (1 listed)
- Participation in a clinical trial or an early access program for HCV therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantify effectiveness of daclatasvir (DCV) containing regimen overall and in subgroups (GT1, non GT1 and cirrhotic patients) by measuring sustained virologic response (SVR12)
Time frame: Upto week 12 after the end of HCV treatment (SVR12)
SVR12 defined as a documented undetectable viral load on or after week 12 following the end of treatment
6 secondary outcomes
SVR12 in patients treated with DCV-containing regimens in real-life by treatment regimen, genotype, cirrhosis stage, HCV-treatment experience, HIV coinfection, and previous LTx (if present)
Time frame: Upto week 12 after the end of HCV treatment (SVR12)
Proportion of patients on DCV-containing regimens achieving SVR12 in real-life compared with SVR12 rates in clinical trials
Time frame: Upto week 12 after the end of HCV treatment (SVR12)
Safety of DCV-containing regimens in real-life measured by the incidence of (S)AEs and the incidence leading to treatment discontinuation
Time frame: Until completion of study
Demographic and clinical characteristics and treatment patterns of patients starting a new HCV treatment regimen (with or without DCV), overall and by treatment regimen,GT,cirrhosis stage,HCV-treatment experience,HIV co-infection,and previous LTx
Time frame: Baseline (single assessment)
Comparison of demographic and clinical characteristics of patients starting a new HCV treatment regimen (with or without DCV) by treatment regimen and to identify factors associated with the initiation of different regimens
Time frame: Baseline (single assessment)
SVR 24 in patients treated with DCV-containing regimens in real-life clinical care, change of Child-Pugh Score and Metavir score as well as change of patient related outcomes (EQ-5D and SF-36 questionnaires measuring quality of life)
Time frame: Upto week 24 after the end of HCV treatment (SVR24)
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 7 Mar 2017.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis, run by Bristol-Myers Squibb at 1 site in Germany.
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 4 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
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?
Quantify effectiveness of daclatasvir (DCV) containing regimen overall and in subgroups (GT1, non GT1 and cirrhotic patients) by measuring sustained virologic response (SVR12) (time frame: Upto week 12 after the end of HCV treatment (SVR12)). 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 7 Mar 2017.