Clinical Study With Silymarin in the Patients With Chronic Hepatitis C Infection Who Failed Conventional Antiviral Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01258686
First received: December 10, 2010
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Silymarin
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Phase III Study With Silymarin in the Patients Infected With HCV Who Failed Conventional Antiviral Therapy

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the change from baseline in ALT and HCV RNA (log10) [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 53
Study Start Date: November 2010
Study Completion Date: August 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: silymarin, treatment Drug: Silymarin
700mg thrice daily
Placebo Comparator: placebo Drug: Placebo
Placebo 700mg thrice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age at least 18 years at screening.
  2. Serum HCV RNA above quantifiable level of detection after the end of previous therapy.
  3. ALT > 60 IU/L (i.e., approximately 1.5 X upper limit of normal) obtained during the screening period.
  4. 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
  5. Negative urine pregnancy test (for women of childbearing potential). Females of childbearing potential must be using effective contraception during the study.

Exclusion Criteria:

  1. ALT ≥ 10*ULN(Upper Limit of Normal) at the screening
  2. Use of silymarin or other milk thistle preparations within 30 days prior to screening.
  3. 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.
  4. 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.
  5. Any antiviral therapy within 6 months prior to screening visit.
  6. Known allergy/sensitivity to milk thistle or its preparations.
  7. Evidence of poorly-controlled diabetes (defined as HbA1c > 8% in patients with diabetes).
  8. Use of warfarin, metronidazole or acetaminophen (greater than two grams per day) within 30 days of screening.
  9. Previous Radiology test(Ultrasonography, Computed tomography,Magnetic Resonance Imaging) or liver biopsy that demonstrated presence of moderate to severe steatosis or evidence of steatohepatitis.
  10. Positive test for anti-HIV or HBsAg within 5 years of screening.
  11. 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.
  12. History of other chronic liver disease, including metabolic diseases, documented by appropriate test(s).
  13. Women with ongoing pregnancy or breast-feeding, or contemplating pregnancy.
  14. 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.
  15. Evidence of drug abuse within 6 months prior to screening or during the screening period.
  16. 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.
  17. 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).
  18. 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.
  19. History of solid organ or bone marrow transplantation.
  20. History of thyroid disease poorly controlled on prescribed medications.
  21. Use of oral steroids for more than 14 days within 30 days prior to screening.
  22. Participation in a research drug trial within 6 months of enrollment.
  23. Inability or unwillingness to provide informed consent or abide by the study protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258686

Locations
Korea, Republic of
Byung Chul, Yoo
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: Byung Chul Yoo, MD. PhD. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01258686     History of Changes
Other Study ID Numbers: BK SIL-C-301
Study First Received: December 10, 2010
Last Updated: November 22, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014