Fibrosis, Liverfib-reversalNCT03659058
Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR
A study testing silymarin, Ursodeoxycholic Acid and Antioxidants in people with Fibrosis, Liver, run by Zagazig University.
Trial summary
with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibrosis, Liver
- What is being tested?
- silymarin, Ursodeoxycholic Acid and Antioxidants
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2016to 1 Aug 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic HCV
- compensated liver disease (Child class A-B)
- sustained virological response
- liver stiffness by fibroscan >12.5 kPa denotes cirrhosis
Who cannot join
- decompensated liver disease
- chronic active HCV
- hepatocellular carcinoma
- other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced liver disease
- pregnancy
About this study
Official title: Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response
with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.
- Conditions
- Fibrosis, Liver
- Being tested
- silymarin, Ursodeoxycholic Acid, Antioxidants, Colchicine, FOLLOW UP
- Keywords
- fibrosis, HCV, Reversal, sustained virological response
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silymarinDrug
Also called silymarin 140
silymarin 140 three times daily
Ursodeoxycholic AcidDrug
Also called ursofalk
Ursodeoxycholic Acid 500
AntioxidantsDrug
Also called antox
Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg
ColchicineDrug
Colchicine 0.6
FOLLOW UPOther
Also called ultrasound and fibroscan
follow up by abdominal ultrasound and fibroscan every 6 month for 1 year
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | 200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents Receives: Drug: silymarin; Drug: Ursodeoxycholic Acid; Drug: Antioxidants; Drug: Colchicine; Other: FOLLOW UP |
| control group | Placebo comparator | 200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be followed up without any intervention Receives: Other: FOLLOW UP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in liver stiffness measurement by Fibroscan
Liver stiffness assessment by Fibroscan every 6 months
Measured: 1 year
Improved portal hypertension parameters
Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months
Measured: 1 year
Improved splenic stiffness measurement
assessment by ultrasound and fibroscan
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start2 Mar 2016
- Primary completionAug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosis, LiverStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 patients will receive silymarin 420 mg + antioxidants + colchicine
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Amr Shaaban Hanafy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659058
- Sponsor's protocol ID
- 37801
- Acronym
- fib-reversal
- Status last verified
- Nov 2018
- First submitted
- 6 Aug 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After Achieving Sustained Virological Response
- ClinicalTrials.gov ID
- NCT03659058
- Acronym / sponsor ID
- fib-reversal / 37801
- Conditions
- Fibrosis, Liver
- Keywords
- fibrosis, HCV, Reversal, sustained virological response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 6 Sep 2018 (actual)
- 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.
with the introduction of Direct-acting antiviral agents in the management of HCV, the scope of inclusion criteria had been widened to include patients with compensated cirrhosis and even in special situations patients with decompensated liver disease; a chance that was not offered by the limited and strict inclusion criteria needed for treatment by pegylated interferon-based regimen. this made the number of patients with progressive liver fibrosis of cirrhosis had been inv=creased even after achieving SVR. the debate about the impact of SVR on halting fibrosis progression had risen; some studies postulated that patients benefit from an SVR through reduction of mortality, morbidity, and improved quality of life ; however, some patients may maintain their level of fibrosis or even progress to cirrhosis despite achieving SVR and the risk for HCC remains even after virologic eradication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 200 patients will receive silymarin 420 mg + antioxidants + colchicine
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: silymarin, Drug: Ursodeoxycholic Acid, Drug: Antioxidants, Drug: Colchicine, Other: FOLLOW UP200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be treated by anti-fibrotic agents |
| control group | Placebo comparator | Other: FOLLOW UP200 patients with compensated liver cirrhosis (F4) by fibroscan; Child Turcotte Pugh score A, after achieving sustained virological response will be followed up without any intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- chronic HCV
- compensated liver disease (Child class A-B)
- sustained virological response
- liver stiffness by fibroscan >12.5 kPa denotes cirrhosis
Key exclusion criteria (5 listed)
- decompensated liver disease
- chronic active HCV
- hepatocellular carcinoma
- other liver diseases as alcoholic liver disease, autoimmune liver disease, drug-induced 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 |
|---|---|---|
| silymarinAlso: silymarin 140silymarin 140 three times daily | Drug | study group |
| Ursodeoxycholic AcidAlso: ursofalkUrsodeoxycholic Acid 500 | Drug | study group |
| AntioxidantsAlso: antoxBeta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg | Drug | study group |
| ColchicineColchicine 0.6 | Drug | study group |
| FOLLOW UPAlso: ultrasound and fibroscanfollow up by abdominal ultrasound and fibroscan every 6 month for 1 year | Other | control group, study group |
Primary outcome
Improvement in liver stiffness measurement by Fibroscan
Time frame: 1 year
Liver stiffness assessment by Fibroscan every 6 months
Improved portal hypertension parameters
Time frame: 1 year
Assessment of portal vein diameter, splenic vein diameter, portal vein congestive index by ultrasound and Doppler every 6 months
Improved splenic stiffness measurement
Time frame: 1 year
assessment by ultrasound and fibroscan
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 27 Nov 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing silymarin, Ursodeoxycholic Acid and Antioxidants in people with Fibrosis, Liver, run by Zagazig University.
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 5 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Improvement in liver stiffness measurement by Fibroscan (time frame: 1 year). The study lists 3 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 27 Nov 2018.