Hepatitis CPhase 3NCT01258686
Clinical Study With Silymarin in the Patients With Chronic Hepatitis C Infection Who Failed Conventional Antiviral Therapy
A Phase 3 study testing Silymarin in people with Hepatitis C, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the effectiveness of silymarin 700 mg thrice daily and assess the safety in patients with hepatitis C virus infection compared to a placebo. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Silymarin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2010to Aug 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years at screening.
- Serum HCV RNA above quantifiable level of detection after the end of previous therapy.
- ALT > 60 IU/L (i.e., approximately 1.5 X upper limit of normal) obtained during the screening period.
- Previous treatment with any interferon-based therapy but 1) without sustained virological response or 2) HCV RNA detected at the end of the treatment or 3) HCV RNA undetected during the treatment and detected after or 4) have partial response(HCV RNA < 2log10 but is not eradicated) or 5) have no response or 6) discontinuation due to side effect
- Negative urine pregnancy test (for women of childbearing potential). Females of childbearing potential must be using effective contraception during the study.
Who cannot join
- ALT ≥ 10*ULN(Upper Limit of Normal) at the screening
- Use of silymarin or other milk thistle preparations within 30 days prior to screening.
- Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening. A multivitamin at standard doses will be allowed.
- Use of silymarin or other antioxidants or non-prescribed complementary alternative medications (as above) during the screening period or patient unwilling to refrain from taking these medications through completion of the study.
- Any antiviral therapy within 6 months prior to screening visit.
- Known allergy/sensitivity to milk thistle or its preparations.
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- Evidence of poorly-controlled diabetes (defined as HbA1c > 8% in patients with diabetes).
- Use of warfarin, metronidazole or acetaminophen (greater than two grams per day) within 30 days of screening.
- Previous Radiology test(Ultrasonography, Computed tomography,Magnetic Resonance Imaging) or liver biopsy that demonstrated presence of moderate to severe steatosis or evidence of steatohepatitis.
- Positive test for anti-HIV or HBsAg within 5 years of screening.
- Average alcohol consumption of more than one drink or equivalent (>12 grams) per day or more than two (2) drinks on any one day over the 30 days prior to screening. Patients who met either criterion more than 30 days ago must have consumed a monthly average of 12 grams or less per day of alcohol for at least six months prior to screening.
- History of other chronic liver disease, including metabolic diseases, documented by appropriate test(s).
- Women with ongoing pregnancy or breast-feeding, or contemplating pregnancy.
- Serum creatinine level 2.0 mg/dL or greater at screening or CrCl ≤ 60cc/min, or currently on dialysis. The creatinine clearance (CrCl) will be calculated according to Cockcroft-Gault.
- Evidence of drug abuse within 6 months prior to screening or during the screening period.
- Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dl, total bilirubin > 2.0 mg/dl, or PT/INR > 1.3 times normal at screening, or history or presence of ascites or encephalopathy, or bleeding from esophageal varices.
- History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).
- History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hepatitis, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis) that could affect inflammatory biomarkers.
- History of solid organ or bone marrow transplantation.
- History of thyroid disease poorly controlled on prescribed medications.
- Use of oral steroids for more than 14 days within 30 days prior to screening.
- Participation in a research drug trial within 6 months of enrollment.
- Inability or unwillingness to provide informed consent or abide by the study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Phase III Study With Silymarin in the Patients Infected With HCV Who Failed Conventional Antiviral Therapy
The purpose of this study is to determine the effectiveness of silymarin 700 mg thrice daily and assess the safety in patients with hepatitis C virus infection compared to a placebo.
- Conditions
- Hepatitis C
- Being tested
- Silymarin, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilymarinDrug
700mg thrice daily
PlaceboDrug
Placebo 700mg thrice daily
| Study group | Role | What they receive |
|---|---|---|
| silymarin, treatment | Experimental | Not described Receives: Drug: Silymarin |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patient with serum ALT less than or equal to 40 IU/L or achieves at least 50% decline to less than 60 IU/L
Measured: at week 24
Secondary outcomes (1)
the change from baseline in ALT and HCV RNA (log10)
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byung Chul Yoo, MD. PhD., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01258686
- Sponsor's protocol ID
- BK SIL-C-301
- Status last verified
- Nov 2013
- First submitted
- 10 Dec 2010
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Phase III Study With Silymarin in the Patients Infected With HCV Who Failed Conventional Antiviral Therapy
- ClinicalTrials.gov ID
- NCT01258686
- Acronym / sponsor ID
- BK SIL-C-301
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Dec 2010 (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 determine the effectiveness of silymarin 700 mg thrice daily and assess the safety in patients with hepatitis C virus infection compared to a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silymarin, treatment | Experimental | Drug: Silymarin |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age at least 18 years at screening.
- Serum HCV RNA above quantifiable level of detection after the end of previous therapy.
- ALT > 60 IU/L (i.e., approximately 1.5 X upper limit of normal) obtained during the screening period.
- Previous treatment with any interferon-based therapy but 1) without sustained virological response or 2) HCV RNA detected at the end of the treatment or 3) HCV RNA undetected during the treatment and detected after or 4) have partial response(HCV RNA < 2log10 but is not eradicated) or 5) have no response or 6) discontinuation due to side effect
- Negative urine pregnancy test (for women of childbearing potential). Females of childbearing potential must be using effective contraception during the study.
Key exclusion criteria (23 listed)
- ALT ≥ 10*ULN(Upper Limit of Normal) at the screening
- Use of silymarin or other milk thistle preparations within 30 days prior to screening.
- Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, or non-prescribed complementary alternative medications (including dietary supplements, megadose vitamins, herbal preparations, and special teas) within 30 days prior to screening. A multivitamin at standard doses will be allowed.
- Use of silymarin or other antioxidants or non-prescribed complementary alternative medications (as above) during the screening period or patient unwilling to refrain from taking these medications through completion of the study.
- Any antiviral therapy within 6 months prior to screening visit.
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 |
|---|---|---|
| Silymarin700mg thrice daily | Drug | silymarin, treatment |
| PlaceboPlacebo 700mg thrice daily | Drug | placebo |
Primary outcome
The proportion of patient with serum ALT less than or equal to 40 IU/L or achieves at least 50% decline to less than 60 IU/L
Time frame: at week 24
1 secondary outcome
the change from baseline in ALT and HCV RNA (log10)
Time frame: 36 weeks
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 25 Nov 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.
Byung Chul Yoo, MD. PhD. principal investigator
Samsung Medical Center
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 Silymarin in people with Hepatitis C, run by Bukwang Pharmaceutical at 1 site in South Korea.
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 5 inclusion and 23 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 25 Nov 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 South Korea. 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?
The proportion of patient with serum ALT less than or equal to 40 IU/L or achieves at least 50% decline to less than 60 IU/L (time frame: at week 24). 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 25 Nov 2013.