Status:
COMPLETED
Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Silymarin (Legalon), also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores. People with liver disease sometimes use silymarin because it is thought to...
Detailed Description
This proposal is a phase II study that will evaluate the safety and efficacy of silymarin for the treatment of subjects with chronic hepatitis C who did not respond to conventional antiviral therapy. ...
Eligibility Criteria
Inclusion
- Age at least 18 years at screening.
- Serum HCV RNA above quantifiable level of detection by any assay after the end of previous therapy.
- ALT \> 65 IU/L (i.e., approximately 1.5 X upper limit of normal) obtained during the screening period.
- Previous treatment with any interferon-based therapy without sustained virological response.
- 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).
Exclusion
- 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.
- 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.
- Lactose intolerance defined as patient reported inability to tolerate milk products.
- Previous 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 \> 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 for more than 14 days within 30 days prior to screening.
- Participation in a research drug trial, exclusive of the SyNCH Phase I trial, within 6 months of enrollment.
- Inability or unwillingness to provide informed consent or abide by the study protocol.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT00680342
Start Date
April 1 2008
End Date
January 1 2011
Last Update
March 18 2013
Active Locations (5)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 00215
2
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107