Chronic Hepatitis CPhase 2RIBACIRNCT00840489
Efficacy of Long-term Ribavirin in Non-responders With Chronic Hepatitis C and Advanced Fibrosis
A Phase 2 study testing Ribavirin and Colchicine in people with Chronic Hepatitis C, run by Hospital Universitario Ramon y Cajal at 3 sites in Spain.
Trial summary
The rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1 with advanced fibrosis (>F2) is rather low. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Ribavirin and Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSpain
- Study dates
- Jan 2009to Dec 2012
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV RNA in serum
- AST/ALT greater than the upper limit of normal range
- HVPG >5 mm Hg
- Non-response or contraindication to a standard course of antiviral therapy
Who cannot join
- Active alcoholism
- HIV infection
- Serum creatinine >1.2 mg/dl, hemoglobin <11 g/dl, hemolysis, symptomatic ischemic heart disease or cerebrovascular disease
- Decompensated chronic liver disease
- Pregnancy
- Hypersensitivity to the drugs of the study
- Severe concomitant disease
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, Madrid, 28034
Hospital Universitario Puerta de Hierro-Majadahonda
Madrid, Madrid, 28222
About this study
Official title: Phase II Trial of Long-term Monotherapy With Ribavirin Against Colchicine on Progression of Chronic Hepatitis C With Advanced Fibrosis in Patients With Non-response to Standard Antiviral Therapy
The rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1 with advanced fibrosis (>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and necroinflammatory liver activity in up to a half of non-responders to standard antiviral therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration. We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory effects, and could constitute an alternative to non-responders to standard antiviral treatment. Portal pressure measurement has become a validated surrogate outcome measure in chronic liver disease, since decreasing portal pressure has shown consistent improvement in survival and clinical outcomes, such as complications of portal hypertension. The primary aim of this study is to investigate whether ribavirin monotherapy slows the progression of advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.
- Conditions
- Chronic Hepatitis C
- Being tested
- Ribavirin, Colchicine
- 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.
RibavirinDrug
Also called Rebetol
Ribavirin 1000-1200 mg qd for 24 weeks
ColchicineDrug
Also called Colchimax
Colchicine 0.5 mg bd for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ribavirin | Experimental | Ribavirin 1000-1200 mg qd Receives: Drug: Ribavirin |
| Colchicine | Active comparator | Colchicine 0.5 mg bd Receives: Drug: Colchicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic disease progression defined by a difference of >2 mmHg in the hepatic venous gradient between the basal values and the end of treatment values in both groups
Measured: 24 weeks
Secondary outcomes (1)
Decrease in the necroinflammatory activity and in the progression of fibrosis. Normalization of ALT levels.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Preliminary analysis
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustin Albillos, Hospital Universitario Ramon y Cajal
- Investigators
- Agustín Albillos, MD, Principal investigator, Hospital Universitario Ramon y CajalJosé Luis Calleja, MD, Study director, Hospital Universitario Puerta de Hierro MajadahondaRafael Bañares, MD, Study director, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840489
- Sponsor's protocol ID
- RIBACIR-1
- Acronym
- RIBACIR
- Status last verified
- Jan 2013
- First submitted
- 9 Feb 2009
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Long-term Monotherapy With Ribavirin Against Colchicine on Progression of Chronic Hepatitis C With Advanced Fibrosis in Patients With Non-response to Standard Antiviral Therapy
- ClinicalTrials.gov ID
- NCT00840489
- Acronym / sponsor ID
- RIBACIR / RIBACIR-1
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Preliminary analysis
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Feb 2009 (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 rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1 with advanced fibrosis (>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and necroinflammatory liver activity in up to a half of non-responders to standard antiviral therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration. We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory effects, and could constitute an alternative to non-responders to standard antiviral treatment. Portal pressure measurement has become a validated surrogate outcome measure in chronic liver disease, since decreasing portal pressure has shown consistent improvement in survival and clinical outcomes, such as complications of portal hypertension. The primary aim of this study is to investigate whether ribavirin monotherapy slows the progression of advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ribavirin | Experimental | Drug: RibavirinRibavirin 1000-1200 mg qd |
| Colchicine | Active comparator | Drug: ColchicineColchicine 0.5 mg bd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HCV RNA in serum
- AST/ALT greater than the upper limit of normal range
- HVPG >5 mm Hg
- Non-response or contraindication to a standard course of antiviral therapy
Key exclusion criteria (7 listed)
- Active alcoholism
- HIV infection
- Serum creatinine >1.2 mg/dl, hemoglobin <11 g/dl, hemolysis, symptomatic ischemic heart disease or cerebrovascular disease
- Decompensated chronic liver disease
- Pregnancy
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 |
|---|---|---|
| RibavirinAlso: RebetolRibavirin 1000-1200 mg qd for 24 weeks | Drug | Ribavirin |
| ColchicineAlso: ColchimaxColchicine 0.5 mg bd for 24 weeks | Drug | Colchicine |
Primary outcome
Hepatic disease progression defined by a difference of >2 mmHg in the hepatic venous gradient between the basal values and the end of treatment values in both groups
Time frame: 24 weeks
1 secondary outcome
Decrease in the necroinflammatory activity and in the progression of fibrosis. Normalization of ALT levels.
Time frame: 24 weeks
Results and safety
The study was stopped early (reason given: Preliminary analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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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.
Agustín Albillos, MD principal investigator
Hospital Universitario Ramon y Cajal
José Luis Calleja, MD study director
Hospital Universitario Puerta de Hierro Majadahonda
Rafael Bañares, MD study director
Hospital General Universitario Gregorio Marañon
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ribavirin and Colchicine in people with Chronic Hepatitis C, run by Hospital Universitario Ramon y Cajal at 3 sites 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Preliminary analysis). Results are not available in the source record.
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?
Hepatic disease progression defined by a difference of >2 mmHg in the hepatic venous gradient between the basal values and the end of treatment values in both groups (time frame: 24 weeks). 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 31 Jan 2013.