Chronic Hepatitis CGGSTNCT01492998
Role of FXR in Hepatitis C Virus Replication
A study testing guggulsterone, a natural FXR antagonist. in people with Chronic Hepatitis C, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- guggulsterone, a natural FXR antagonist.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Mar 2010
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy
- Viral load > 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months.
- METAVIR score < F4
Who cannot join
- Alcohol intake > 20 g/day
- Immuno - suppressive therapy
- Obesity BMI > 30, diabetes
- Dyslipidemia requiring specific therapy
- Liver cirrhosis or carcinoma
- HIV or HBV co-infections
Show all 9Show fewer
- Other liver diseases
- Major organ failures
- Therapy with cytochrome P450 metabolized drugs
Trial locations and contacts
1 site in 1 country.
France1 site
Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu
Lyon, 69288
About this study
Official title: Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication
In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.
- Conditions
- Chronic Hepatitis C
- Being tested
- guggulsterone, a natural FXR antagonist.
- Keywords
- Hepatitis C virus, Biliary salts, Farnesoid X receptor, Guggulsterone
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guggulsterone, a natural FXR antagonist.Other
Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone
| Study group | Role | What they receive |
|---|---|---|
| Guggulsterone | Experimental | One arm of 15 chronically HCV genotype one infected patients Receives: Other: guggulsterone, a natural FXR antagonist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
Measured: One week
Secondary outcomes (1)
Modification of the fraction of the circulating viral forms associated with apolipoprotein B
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJan 2010
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Trépo, MD, Prof., Principal investigator, Hospices Civils de LyonMarianne Maynard, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492998
- Sponsor's protocol ID
- 2008.501-02
- Acronym
- GGST
- Status last verified
- Sep 2010
- First submitted
- 23 Sep 2010
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Scholtes C, Andre P, Trepo C, Cornu C, Remontet L, Ecochard R, Bejan-Angoulvant T, Gueyffier F. Farnesoid X receptor targeting for hepatitis C: study protocol for a proof-of-concept trial. Therapie. 2012 Sep-Oct;67(5):423-7. doi: 10.2515/therapie/2012058. Epub 2012 Dec 18.
PubMed 23241251
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of the Biliary Salts Nuclear Receptor FXR in Hepatitis C Virus Replication
- ClinicalTrials.gov ID
- NCT01492998
- Acronym / sponsor ID
- GGST / 2008.501-02
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C virus, Biliary salts, Farnesoid X receptor, Guggulsterone
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- First posted
- 15 Dec 2011 (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.
In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guggulsterone | Experimental | Other: guggulsterone, a natural FXR antagonist.One arm of 15 chronically HCV genotype one infected patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy
- Viral load > 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months.
- METAVIR score < F4
Key exclusion criteria (9 listed)
- Alcohol intake > 20 g/day
- Immuno - suppressive therapy
- Obesity BMI > 30, diabetes
- Dyslipidemia requiring specific therapy
- Liver cirrhosis or carcinoma
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 |
|---|---|---|
| guggulsterone, a natural FXR antagonist.Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone | Other | Guggulsterone |
Primary outcome
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.
Time frame: One week
1 secondary outcome
Modification of the fraction of the circulating viral forms associated with apolipoprotein B
Time frame: One week
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
- Derived from this study: PubMed 23241251Scholtes C, Andre P, Trepo C, Cornu C, Remontet L, Ecochard R, Bejan-Angoulvant T, Gueyffier F. Farnesoid X receptor targeting for hepatitis C: study protocol for a proof-of-concept trial. Therapie. 2012 Sep-Oct;67(5):423-7. doi: 10.2515/therapie/2012058. Epub 2012 Dec 18.
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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.
Christian Trépo, MD, Prof. principal investigator
Hospices Civils de Lyon
Marianne Maynard, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guggulsterone, a natural FXR antagonist. in people with Chronic Hepatitis C, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 9 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 15 Dec 2011. 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 France. 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 was stopped early. 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?
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone. (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01492998, which also lists 1 linked publication.
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 15 Dec 2011.