Chronic Hepatitis CAURICNCT02628717
Interferon/Ribavirin-Free Sofosbuvir Based Treatment (AURIC)
An observational study of Chronic Hepatitis C and Cirrhosis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C, Cirrhosis
- How many people
- 558 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2013to Sep 2017
- How long will I take part?
- 3 Years
- 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: All patients with fibrosis grade F3 or F4, age >18 years, with indication for antiviral treatment
Who may be able to join
- All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens
Who cannot join
- other disease with poor prognosis (ie. metastatic cancer, heart failure)
- participation in a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interferon/Ribavirin-Free Sofosbuvir Based Treatment Regimens In Patients With Advanced Liver Disease - Results Of A Real-Life Austrian Ribavirin-/Interferon Free Cohort (AURIC)
Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4)
Read the detailed description
From end of 2013 303 HCV-monoinfected patients with advanced liver disease (F3/4) were treated with interferon (IFN)-free and RBV-free SOF-based regimens. During this period only 7 patients received additional RBV. These patients were not included in this analysis. Only patients who completed 12 weeks of treatment-free follow up until July 2015 were included in this analysis. In Austria, prescription of DAAs is restricted to specialized treatment centers. Data are obtained by 6 participating centers and submitted to the central database forming for of the Austrian Ribavirin- and Interferon-free cohort (AURIC). Incoming data are reviewed by the staff of the hepatitis study group of the Dept. of Medicine III, Medical university of Vienna.The treatment regimens consisted of SOF/DCV, SOF/SMV, and SOF/LDV. The duration of treatment was based on a response guided approach at the discretion of the treating physician (12 or 24 weeks).
Sixty six patients who had started therapy before August 2014 received SMV or DCV as part of a named patient program, SOF was prescribed. For the remaining patients all drugs were prescribed and paid for by the Austrian social insurance.
This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C:
Sustained virologic response (SVR) defined as undetectable HCV-RNA after 12 weeks of treatment free follow up
Virological breakthrough/relapse defined as reappearance of HCV on treatment/during follow up
Impact of viral kinetics on prediction of treatment efficacy: Viral load measured repeatedly (at baseline, on days 2,7,14,21,28,and than every 4 weeks until end of treatment) allows to study the rapidity of viral clearance. This parameter was used to assess whether length of treatment can be modified. Plasma HCV RNA levels were quantified by One Signal Amplification (Versant HCV RNA 3.0),
Adverse Event Recording (using standard GCP criteria)
Longterm outcome after SVR based on examining patients with SVR in six monh intervals. Examination will include liver sonography, elastography, routine blood chemistry including alpha1-fetoprotein
- Conditions
- Chronic Hepatitis C, Cirrhosis
- Keywords
- Hepatitis C, sofosbuvir, ledipasvir, daclatasvir, simeprevir
- Medical subject headings
- Hepatitis C, Chronic, Fibrosis, Hepatitis C
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 |
|---|---|---|
| SOF/SMV | SOF/SMV 400mg/150mg QD 12-24 weeks | |
| SOF/DCV | SOF/DCV 400mg/60mg QD 12-24 weeks | |
| SOF/LDV | SOF/LDV 400mg/90mg QD 12-24 weeks | |
| treatment duration | 12 - 24 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with sustained virologic response (SVR)
SVR is defined by the undetectability of HCV-RNA after 12 weeks of treatment free follow up
Measured: 12 weeks treatment free follow up
Secondary outcomes (2)
On treatment predictability of SVR
Virus testing at baseline, day 2,7,14,21,28, than every 4 weeks until SVR. Rapidity of viral clearance may be a useful parameter to determine the duration of treatment
Measured: 12/24 weeks of treatment + 12 weeks of follow up
Number of patients with liver events (Mortality, Hepatic decompensation, Variceal Bleeding,Hepatocellular Carcinoma, Need for Liver Transplantation) on longterm clinical outcome
regular clinical visits including laboratory test, fibroscan and sonography will be performed every six months after achieving SVR
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 558 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Ferenci, Medical University of Vienna
- Investigators
- Harald Hofer, MD,Prof, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628717
- Sponsor's protocol ID
- I3MHCV
- Acronym
- AURIC
- Status last verified
- Sep 2017
- First submitted
- 3 Dec 2015
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon/Ribavirin-Free Sofosbuvir Based Treatment Regimens In Patients With Advanced Liver Disease - Results Of A Real-Life Austrian Ribavirin-/Interferon Free Cohort (AURIC)
- ClinicalTrials.gov ID
- NCT02628717
- Acronym / sponsor ID
- AURIC / I3MHCV
- Conditions
- Chronic Hepatitis C, Cirrhosis
- Keywords
- Hepatitis C, sofosbuvir, ledipasvir, daclatasvir, simeprevir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Dec 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.
Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4)
Detailed description
From end of 2013 303 HCV-monoinfected patients with advanced liver disease (F3/4) were treated with interferon (IFN)-free and RBV-free SOF-based regimens. During this period only 7 patients received additional RBV. These patients were not included in this analysis. Only patients who completed 12 weeks of treatment-free follow up until July 2015 were included in this analysis. In Austria, prescription of DAAs is restricted to specialized treatment centers. Data are obtained by 6 participating centers and submitted to the central database forming for of the Austrian Ribavirin- and Interferon-free cohort (AURIC). Incoming data are reviewed by the staff of the hepatitis study group of the Dept. of Medicine III, Medical university of Vienna.The treatment regimens consisted of SOF/DCV, SOF/SMV, and SOF/LDV. The duration of treatment was based on a response guided approach at the discretion of the treating physician (12 or 24 weeks).
Sixty six patients who had started therapy before August 2014 received SMV or DCV as part of a named patient program, SOF was prescribed. For the remaining patients all drugs were prescribed and paid for by the Austrian social insurance.
This study will investigate various aspects of treatment response to regimens containing direct-acting antiviral agents for the treatment of chronic hepatitis C:
Sustained virologic response (SVR) defined as undetectable HCV-RNA after 12 weeks of treatment free follow up
Virological breakthrough/relapse defined as reappearance of HCV on treatment/during follow up
Impact of viral kinetics on prediction of treatment efficacy: Viral load measured repeatedly (at baseline, on days 2,7,14,21,28,and than every 4 weeks until end of treatment) allows to study the rapidity of viral clearance. This parameter was used to assess whether length of treatment can be modified. Plasma HCV RNA levels were quantified by One Signal Amplification (Versant HCV RNA 3.0),
Adverse Event Recording (using standard GCP criteria)
Longterm outcome after SVR based on examining patients with SVR in six monh intervals. Examination will include liver sonography, elastography, routine blood chemistry including alpha1-fetoprotein
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SOF/SMV | – | –SOF/SMV 400mg/150mg QD 12-24 weeks |
| SOF/DCV | – | –SOF/DCV 400mg/60mg QD 12-24 weeks |
| SOF/LDV | – | –SOF/LDV 400mg/90mg QD 12-24 weeks |
| treatment duration | – | –12 - 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with fibrosis grade F3 or F4, age >18 years, with indication for antiviral treatment
Key inclusion criteria (1 listed)
- All adult patients (age 18 or older) being treated with antiviral HCV treatment regimens
Key exclusion criteria (2 listed)
- other disease with poor prognosis (ie. metastatic cancer, heart failure)
- participation in a clinical trial
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
Number of patients with sustained virologic response (SVR)
Time frame: 12 weeks treatment free follow up
SVR is defined by the undetectability of HCV-RNA after 12 weeks of treatment free follow up
2 secondary outcomes
On treatment predictability of SVR
Time frame: 12/24 weeks of treatment + 12 weeks of follow up
Number of patients with liver events (Mortality, Hepatic decompensation, Variceal Bleeding,Hepatocellular Carcinoma, Need for Liver Transplantation) on longterm clinical outcome
Time frame: 3 years
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 6 Sep 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.
Harald Hofer, MD,Prof principal investigator
Medical University of Vienna
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 Chronic Hepatitis C and Cirrhosis, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 2 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 6 Sep 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 Austria. 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?
Number of patients with sustained virologic response (SVR) (time frame: 12 weeks treatment free follow up). 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 6 Sep 2017.