Chronic Hepatitis CSPLEEN-CNCT02439567
Transient Elastography to Assess Liver Fibrosis and Portal Hypertension in HCV Cirrhotic Patients Treated With New Antiviral Drugs (SPLEEN-C)
A study testing Fibroscan: Liver and Spleen elastography in people with Chronic Hepatitis C and Cirrhosis, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Hepatitis C, Cirrhosis, Portal Hypertension
- What is being tested?
- Fibroscan: Liver and Spleen elastography
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Sep 2016
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 90 years.
- History of chronic hepatitis C infection.
- Compensated advanced chronic liver disease (Baveno VI definition):
- Baseline liver stiffness ≥15 kPa or,
- Baseline liver stiffness 10-15 kPa and one of the following: platelet count <150x10e9/L, spleen size ≥13 cm, nodular liver or collateral circulation in abdominal ultrasound, HVPG >5 mmHg, upper gastrointestinal endoscopy showing gastroesophageal varices or previous liver biopsy showing bridging fibrosis or cirrhosis.
- Indication to start antiviral treatment with new oral drugs.
- Willingness to enter the study.
- Sign the informed consent.
Who cannot join
- Chronic liver disease due to other etiology than HCV.
- Terminal illness.
- Treatment with interferon.
- Liver stiffness measurement < 10 kPa at baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Usefulness of Transient Elastography Assessing Liver Fibrosis and Portal Hypertension in Patients With HCV Cirrhosis Treated With New All Oral Antiviral Drugs
The purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.
Read the detailed description
Prospective cohort study including consecutive patients (with baseline liver stiffness measurement ≥10 kPa who meet the Baveno VI criteria for compensated advanced chronic liver disease) who initiate treatment with new all oral antiviral drugs following current recommendations in Spain.
In all these patients the following parameters will be assessed:
- Baseline liver and spleen stiffness and CAP measurements at the time of starting therapy and then, during treatment in week 4 and week 12 (end of treatment). After finishing therapy, these measurements will be repeated at 6 and 12 months of follow-up.
- Routine lab tests, including liver enzymes and viral load, will be performed at baseline, 4 and 12 weeks of therapy, and at 3 and 6 months after finishing therapy according to standard clinical practice.
- Liver ultrasound will be performed every 6 months as a routine procedure in patients wiht liver cirrhosis.
- Patients who were known to have esophageal varices prior to therapy will be assessed with an upper endoscopy 12 months after finishing therapy if they achieve SVR.
- Conditions
- Chronic Hepatitis C, Cirrhosis, Portal Hypertension
- Being tested
- Fibroscan: Liver and Spleen elastography
- Keywords
- Cirrhosis, Chronic hepatitis C, Clinically significant portal hypertension, Portal hypertension, Elastography, Antiviral therapy
- Medical subject headings
- Hepatitis C, Chronic, Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibroscan: Liver and Spleen elastographyDevice
In cirrhotic patients treated with antivirals for HCV infection, repeated liver and spleen stiffness measures with Fibroscan will be performed to predict the presence of clinically significant and severe portal hypertension.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Treatment with new oral antiviral drugs for HCV infection, Fibroscan: Liver and Spleen elastography Receives: Device: Fibroscan: Liver and Spleen elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR).
Measured: 6 months
Spleen stiffness change during treatment and at 6 months of follow-up in patients who achieve SVR.
Measured: 6 months
Secondary outcomes (1)
Overall survival (Composite outcome including survival free of all cause of death, liver transplantation, decompensation and/or increase in >1 point in Child Pugh score).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2016
- Study completionSep 2016
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 Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan Genescà Ferrer, PhD MD, Principal investigator, Hospital Universitari Vall d'hebron Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439567
- Sponsor's protocol ID
- SPLEEN-C (JOA-SOF-2015-01)
- Acronym
- SPLEEN-C
- Status last verified
- May 2017
- First submitted
- 27 Apr 2015
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Transient Elastography Assessing Liver Fibrosis and Portal Hypertension in Patients With HCV Cirrhosis Treated With New All Oral Antiviral Drugs
- ClinicalTrials.gov ID
- NCT02439567
- Acronym / sponsor ID
- SPLEEN-C / SPLEEN-C (JOA-SOF-2015-01)
- Conditions
- Chronic Hepatitis C, Cirrhosis, Portal Hypertension
- Keywords
- Cirrhosis, Chronic hepatitis C, Clinically significant portal hypertension, Portal hypertension, Elastography, Antiviral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 May 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 purpose of this study is to evaluate the effects of sustained virological response in liver and spleen stiffness in patients with HCV compensated advanced chronic liver disease treated with new all oral antiviral drugs in order to determine factors implicated in stiffness change and its implications for long-term follow-up.
Detailed description
Prospective cohort study including consecutive patients (with baseline liver stiffness measurement ≥10 kPa who meet the Baveno VI criteria for compensated advanced chronic liver disease) who initiate treatment with new all oral antiviral drugs following current recommendations in Spain.
In all these patients the following parameters will be assessed:
- Baseline liver and spleen stiffness and CAP measurements at the time of starting therapy and then, during treatment in week 4 and week 12 (end of treatment). After finishing therapy, these measurements will be repeated at 6 and 12 months of follow-up.
- Routine lab tests, including liver enzymes and viral load, will be performed at baseline, 4 and 12 weeks of therapy, and at 3 and 6 months after finishing therapy according to standard clinical practice.
- Liver ultrasound will be performed every 6 months as a routine procedure in patients wiht liver cirrhosis.
- Patients who were known to have esophageal varices prior to therapy will be assessed with an upper endoscopy 12 months after finishing therapy if they achieve SVR.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Fibroscan: Liver and Spleen elastographyTreatment with new oral antiviral drugs for HCV infection, Fibroscan: Liver and Spleen elastography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 to 90 years.
- History of chronic hepatitis C infection.
- Compensated advanced chronic liver disease (Baveno VI definition):
- Indication to start antiviral treatment with new oral drugs.
- Willingness to enter the study.
Key exclusion criteria (4 listed)
- Chronic liver disease due to other etiology than HCV.
- Terminal illness.
- Treatment with interferon.
- Liver stiffness measurement < 10 kPa at baseline.
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 |
|---|---|---|
| Fibroscan: Liver and Spleen elastographyIn cirrhotic patients treated with antivirals for HCV infection, repeated liver and spleen stiffness measures with Fibroscan will be performed to predict the presence of clinically significant and severe portal hypertension. | Device | Patients |
Primary outcome
Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR).
Time frame: 6 months
Spleen stiffness change during treatment and at 6 months of follow-up in patients who achieve SVR.
Time frame: 6 months
1 secondary outcome
Overall survival (Composite outcome including survival free of all cause of death, liver transplantation, decompensation and/or increase in >1 point in Child Pugh score).
Time frame: 12 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 11 May 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.
Joan Genescà Ferrer, PhD MD principal investigator
Hospital Universitari Vall d'hebron Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan: Liver and Spleen elastography in people with Chronic Hepatitis C and Cirrhosis, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 4 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 11 May 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 Spain. 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?
Liver stiffness change during treatment and at 6 months of follow-up in patients who achieve sustained virological response (SVR). (time frame: 6 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 11 May 2017.