Liver FibrosisPhase 3NCT01935817
Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV
A Phase 3 study testing Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex in people with Liver Fibrosis, run by University of Catania at 1 site in Italy.
Trial summary
Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC. The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Liver Fibrosis
- What is being tested?
- Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2010to Dec 2012
- Phase
- Phase 3
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older,
- infection by HCV
- under treatment with pegylated interferon 2 alpha and ribavirin
Who cannot join
- other liver diseases
- cancer
- severe jaundice
- pulmonary and renal chronic diseases
- prostatic diseases
- autoimmune diseases
- diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC.
The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.
- Conditions
- Liver Fibrosis
- Being tested
- Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex, Placebo
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complexDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Silybin + vitamin E + phospholipids complex | Active comparator | Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months Receives: Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex |
| sugar pill | Placebo comparator | one placebo pill per day for 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
transforming growth factor beta
serum marker of liver fibrosis
Measured: 12 months
Secondary outcomes (1)
hyaluronic acid
serum marker of liver fibrosis
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 posted5 Sep 2013 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariano Malaguarnera, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935817
- Sponsor's protocol ID
- unict11/1997
- Status last verified
- Sep 2013
- First submitted
- 1 Sep 2013
- Last updated
- 5 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silybin - Vitamin E- Phospholipids Complex Reduces Liver Fibrosis in Patients With Chronic Hepatitis C Treated With Peg-IFN-a and RBV
- ClinicalTrials.gov ID
- NCT01935817
- Acronym / sponsor ID
- unict11/1997
- Conditions
- Liver Fibrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Sep 2013 (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.
Chronic hepatitis C is both a virologic and a fibrotic disease, with mortality resulting mainly from the complications of cirrhosis and HCC.
The investigators' aim will be to evaluate the impact on of supplementation with a new pharmaceutical complex of silybin-vitamin E-phospholipids in patients with chronic hepatitis C treated with Pegylated-Interferon-α2b plus Ribavirin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silybin + vitamin E + phospholipids complex | Active comparator | Drug: Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complexSilybin 94 mg + vitamin E 90 mg + phospholipids 194 mg in one pill per day for 12 months |
| sugar pill | Placebo comparator | Drug: Placeboone placebo pill per day for 12 months |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older,
- infection by HCV
- under treatment with pegylated interferon 2 alpha and ribavirin
Key exclusion criteria (7 listed)
- other liver diseases
- cancer
- severe jaundice
- pulmonary and renal chronic diseases
- prostatic diseases
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 |
|---|---|---|
| Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex | Drug | Silybin + vitamin E + phospholipids complex |
| Placebo | Drug | sugar pill |
Primary outcome
transforming growth factor beta
Time frame: 12 months
serum marker of liver fibrosis
1 secondary outcome
hyaluronic acid
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 5 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex in people with Liver Fibrosis, run by University of Catania at 1 site in Italy.
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 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: finished, as of the sponsor's last update on 5 Sep 2013. 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 Italy. 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
transforming growth factor beta (time frame: 12 months). 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 5 Sep 2013.