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

NCT01258686 | Completed Phase 3

• 1 other identifier: BK SIL-C-301
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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

  at week 24

Secondary Outcomes (1)

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

  36 weeks

Study Arms (2)

silymarin, treatment

EXPERIMENTAL

Drug: Silymarin

placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Silymarin DRUG

700mg thrice daily

silymarin, treatment

Placebo DRUG

Placebo 700mg thrice daily

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Byung Chul, Yoo

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Byung Chul Yoo, MD. PhD.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2010
• First Posted: December 13, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: August 1, 2013
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

KR (1)