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Hepatitis CPhase 1SyNCHNCT00389376

Phase I Trial of Silymarin for Chronic Liver Diseases

A Phase 1 study testing Silymarin in people with Hepatitis C and Non-Alcoholic Fatty Liver Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Silymarin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
5 sitesUnited States
Study dates
Nov 2006to Feb 2008
Phase
Phase 1
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

  • Subjects will be eligible for enrollment in this study if they meet the following criteria:
  • Males or females; age at least 18 years at screening
  • Abnormal ALT > 65 IU/L (ie, approximately 1.5 x upper limit of normal)
  • Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of silymarin. Females of childbearing potential must be using two reliable forms of effective contraception during the study (while on drug and during follow-up)
  • Hepatitis C virus (HCV) patients
  • Previous treatment with any interferon-based therapy without sustained virological response.
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  • Serum HCV RNA above quantifiable level of detection by the assay, within 1 year of screening and after the end of therapy
  • No antiviral therapy for at least 6 months prior to screening visit
  • Nonalcoholic fatty liver disease (NAFLD) patients:
  • Liver biopsy compatible with NAFLD within 3 years of screening
  • Absence of other liver diseases by serological screening (anti-HCV, HBsAg), historical serological data from within 3 years of screening is acceptable.
  • Before entering the study, subjects must agree not to consume alcohol for 48 hours prior to PK sampling days or while on study.

Who cannot join

  • Subjects with any of the following will not be eligible for participation:
  • Use of silymarin or other milk thistle preparations within 30 days of screening
  • Use of other antioxidants such as vitamin E, vitamin C, glutathione, alpha-tocopherol, within 30 days of screening. A multivitamin at standard doses will be allowed.
  • Allergy/sensitivity to milk thistle or its preparations
  • Use of silymarin or other antioxidants (as above) during the screening period.
  • Use of warfarin, metronidazole or chronic use of acetaminophen greater than two gram per day
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  • Previous liver biopsy that demonstrated presence of cirrhosis
  • Previous liver biopsy that demonstrated greater than or equal to 15% steatosis or evidence of steatohepatitis for HCV cohort
  • Positive test for anti-HIV or HBsAg within 3 years of screening
  • Positive urine drug screen for drugs of abuse at screening
  • Alcohol consumption of more than one drink or equivalent (>12 grams) per day. Patients who consumed more than this in the past must have maintained a level 12 grams or less per day of alcohol consumption 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
  • Platelet count <130,000 cells/mm3.
  • Serum creatinine level >1.5 times the upper limit of normal at screening, or CrCl 60 cc/min, or currently on dialysis. The creatinine clearance (CrCl) will be calculated according to Cockcroft-Gault.
  • Evidence of alcohol or drug abuse within 6 months prior to screening
  • Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dl, total bilirubin > 1.5 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 within 30 days prior to screening
  • Concurrent medications that are CYP3A4 inducers
  • Inability or unwillingness to provide informed consent or abide by the study protocol

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh, Graduate School of Public Health

    Pittsburgh, Pennsylvania, 15261

Other trials in United States

About this study

Official title: Single and Multiple Dose Escalation Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Orally Administered Silymarin (Legalon) in Non-Cirrhotic Subjects With Chronic Hepatitis C or Non-Alcoholic Fatty Liver Disease

The purpose of this study is to determine the safety and tolerability of different dosages of silymarin on subjects with Hepatitis C or Non-Alcoholic Fatty Liver Disease.

Being tested
Placebo, Silymarin
Medical subject headings
Hepatitis C, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Placebo

  • SilymarinDrug

    Also called Legalon

    140 mg every 8 hours

  • SilymarinDrug

    Also called Legalon

    280 mg single dose

  • SilymarinDrug

    Also called Legalon

    280 mg single dose + every 8 hours

  • SilymarinDrug

    Also called Legalon

    560 mg single dose + every 8 hours

  • SilymarinDrug

    Also called Legalon

    560 mg single dose + every 8 hours

  • SilymarinDrug

    Also called Legalon

    280 mg every 8 hours

  • SilymarinDrug

    Also called Legalon

    700 mg single dose + every 8 hours

Study groups in NCT00389376
Study groupRoleWhat they receive
Group 1OtherPlacebo and 140 mg single dose + every 8 hours
Receives: Drug: Placebo; Drug: Silymarin
Group 2OtherPlacebo and 280 mg single dose
Receives: Drug: Placebo; Drug: Silymarin
Group 3OtherPlacebo and 280mg every 8 hours
Receives: Drug: Placebo; Drug: Silymarin
Group 4OtherPlacebo and 280 single dose + every 8 hours
Receives: Drug: Placebo; Drug: Silymarin
Group 5OtherPlacebo and 560 mg single dose + every 8 hours
Receives: Drug: Placebo; Drug: Silymarin
Group 6OtherPlacebo and 560 mg single dose + every 8 hours
Receives: Drug: Placebo; Drug: Silymarin
Group 7OtherPlacebo and 700 mg single dose + every 8 hours
Receives: Drug: Placebo; Drug: Silymarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionJan 2008
  4. Study completionFeb 2008

Resources

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 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00389376
Sponsor's protocol ID
U01AT003566-01
Other IDs
NIH grant # U01-AT0035661
Acronym
SyNCH
Status last verified
Feb 2008
First submitted
16 Oct 2006
Last updated
20 Feb 2008
Results posted
No
Data monitoring committee
Yes
Expanded access
Available

Publications

  • Schrieber SJ, Hawke RL, Wen Z, Smith PC, Reddy KR, Wahed AS, Belle SH, Afdhal NH, Navarro VJ, Meyers CM, Doo E, Fried MW. Differences in the disposition of silymarin between patients with nonalcoholic fatty liver disease and chronic hepatitis C. Drug Metab Dispos. 2011 Dec;39(12):2182-90. doi: 10.1124/dmd.111.040212. Epub 2011 Aug 24.

    PubMed 21865319

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Silymarin in people with Hepatitis C and Non-Alcoholic Fatty Liver Disease, run by National Center for Complementary and Integrative Health (NCCIH) at 5 sites in United States.

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 12 inclusion and 24 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 20 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Adverse events (time frame: 10 days). 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 NCT00389376, 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 20 Feb 2008.

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