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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Silymarin
Placebo
Sponsored by
Bukwang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Byung Chul, Yoo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

silymarin, treatment

placebo

Arm Description

Outcomes

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

Secondary Outcome Measures

the change from baseline in ALT and HCV RNA (log10)

Full Information

First Posted
December 10, 2010
Last Updated
November 22, 2013
Sponsor
Bukwang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01258686
Brief Title
Clinical Study With Silymarin in the Patients With Chronic Hepatitis C Infection Who Failed Conventional Antiviral Therapy
Official Title
A Double-blind Phase III Study With Silymarin in the Patients Infected With HCV Who Failed Conventional Antiviral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bukwang Pharmaceutical

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
silymarin, treatment
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Silymarin
Intervention Description
700mg thrice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 700mg thrice daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
the change from baseline in ALT and HCV RNA (log10)
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung Chul Yoo, MD. PhD.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byung Chul, Yoo
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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