Hepatitis C, ChronicNCT01671046
An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 10 sites in Brazil.
Trial summary
This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 123 participants
- Where
- 10 sitesBrazil
- Study dates
- Jul 2012to Dec 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: Patients with chronic hepatitis C
Who may be able to join
- Adult patients, >/= 18 years of age
- Chronic Hepatitis C infection (mono-infection or co-infection with human immunodeficiency virus [HIV])
- Detectable level of hepatitis C RNA
- Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines
- Last liver biopsy performed no later than 3 months prior to enrolment to study
Who cannot join
- Co-infection with hepatitis B virus
- Previous treatment with pegylated interferon and ribavirin
- Participation in another clinical study in the last 12 months prior to study start
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
Study site
Botucatu, São Paulo, 18600-400
Study site
Campinas, São Paulo, 13026-210
Study site
Campinas, São Paulo, 13060-803
Study site
Rio de Janeiro, Rio de Janeiro, 20270-004
Study site
Rio de Janeiro, Rio de Janeiro, 21941-590
Study site
Santo André, São Paulo, 09060-650
Study site
São Paulo, São Paulo, 04040-002
Study site
São Paulo, São Paulo, 04040-003
Study site
São Paulo, São Paulo, 05403-000
Study site
Sorocaba, São Paulo, 18047-600
About this study
Official title: Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients
This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.
- Conditions
- Hepatitis C, Chronic
- Medical subject headings
- Hepatitis C, Chronic
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 |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start
Measured: 24 months
Correlation of liver elasticity evolution with viral kinetics
Measured: 24 months
Secondary outcomes (8)
Safety: incidence of adverse events
Measured: 24 months
Correlation of liver fibrosis stages with sustained virological response (SVR)
Measured: 24 months
Correlation of patients characteristics with sustained virological response
Measured: 24 months
Hepatic transient elastography (M-transducer)
Measured: 24 months
Hepatic transient elastography (XL-transducer)
Measured: 24 months
Correlation of hepatic steatosis score with sustained virological response
Measured: 24 months
Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy
Measured: 24 months
Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671046
- Sponsor's protocol ID
- ML27944
- Status last verified
- Nov 2016
- First submitted
- 20 Aug 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients
- ClinicalTrials.gov ID
- NCT01671046
- Acronym / sponsor ID
- ML27944
- Conditions
- Hepatitis C, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 Aug 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.
This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis C
Key inclusion criteria (5 listed)
- Adult patients, >/= 18 years of age
- Chronic Hepatitis C infection (mono-infection or co-infection with human immunodeficiency virus [HIV])
- Detectable level of hepatitis C RNA
- Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines
- Last liver biopsy performed no later than 3 months prior to enrolment to study
Key exclusion criteria (3 listed)
- Co-infection with hepatitis B virus
- Previous treatment with pegylated interferon and ribavirin
- Participation in another clinical study in the last 12 months prior to study start
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
Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start
Time frame: 24 months
Correlation of liver elasticity evolution with viral kinetics
Time frame: 24 months
8 secondary outcomes
Safety: incidence of adverse events
Time frame: 24 months
Correlation of liver fibrosis stages with sustained virological response (SVR)
Time frame: 24 months
Correlation of patients characteristics with sustained virological response
Time frame: 24 months
Hepatic transient elastography (M-transducer)
Time frame: 24 months
Hepatic transient elastography (XL-transducer)
Time frame: 24 months
Correlation of hepatic steatosis score with sustained virological response
Time frame: 24 months
Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy
Time frame: 24 months
Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients
Time frame: 24 months
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 2 Nov 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.
Clinical Trials study director
Hoffmann-La Roche
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 10 sites in Brazil.
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 5 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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?
Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start (time frame: 24 months). The study lists 2 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 2 Nov 2016.