Acute Hepatitis C Clinical Trial
Official title:
A Multicentre, Double-blind, Randomized, Placebo-controlled, Phase II/III Study to Evaluate the Safety and Efficacy of 280 mg and 420 mg Silymarin TID (Legalon® Capsules) Administered for Four Weeks in Subjects With Acute Viral Hepatitis With a Four Week Follow-up Period
Verified date | April 2021 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess whether two higher doses (280mg or 420mg three times daily)of silymarin therapy are safe and tolerable, and shorten the illness in patients with acute viral hepatitis compared to placebo.
Status | Terminated |
Enrollment | 70 |
Est. completion date | December 2015 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of acute viral hepatitis (<1 month) as manifested by a combination of the following symptoms: jaundice, dark-colored urine, light-colored stools, pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, aversion to smoking and right upper abdominal discomfort, pain or feeling of pressure. - Serum ALT level > 2.5 times the upper limit of normal. - Albumin level >3.5 gm/dl - Negative anti-HCV antibody - Males and females >= 18 years of age. - Subject has given written informed consent. If patient is between 18 and 21 years parents/legal guardian have/has also signed the informed consent form. - The subject is able and willing to undertake all study-required procedures and has the ability to take oral medications. Exclusion Criteria: - Subjects < 18 years of age - Pregnant or breastfeeding women - Suspected hypersensitivity to silymarin or multivitamins - Advanced liver disease (e.g. ascites, bleeding esophageal varices and hepatic encephalopathy) - Chronic liver disease as cirrhosis - Subjects with positive anti-HCV antibody - Simultaneous elevation of bilirubin > 10 mg/dl along with an ALT level between 100 and 150 U/L - Platelets count <150,000 - Subjects with morbid obesity i.e. a Body Mass Index (BMI) > 40 - Subjects with severe illness, e.g., multisystem failure, cancer or poorly controlled diabetes i.e. known diabetic with Hemoglobin A1C (HbA1C)>7% - Obvious history of drug-induced acute hepatitis. A careful history of all medications, pesticide and other hepatotoxic exposures occurring within one month prior to symptom onset will be taken. If a patient is unaware of the name of the drugs, (s)he will be asked to bring it for inspection. - Current use of Silymarin or recent use within past two weeks. - Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his/her participation in, and completion of, the protocol (e.g. severe mental illness) - The subject is currently participating in any clinical trial (marketed product or otherwise), or has done so within 30 days or 5 half-lives (whichever is longer) prior to screening visit - History or current drug or alcohol abuse - Female patient with childbearing potential without negative pregnancy test - Patient is known to be HIV positive. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria University Hospital | Alexandria | Alexandria Governorate |
Egypt | Banha Fever Hospital | Benha | Kaluobeya Governorate |
Egypt | Tanta Fever Hospital | Tanta | Gharbeya Governorate |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore | Alexandria University, Banha Fever Hospital, MADAUS GmbH, Tanta Fever Hospital, The Egyptian Company for Blood Transfusion Services |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence, severity and duration of Adverse Events | Four weeks after enrollment | ||
Primary | Normalization of total (<1.0 mg/dl) and direct bilirubin (<0.3 mg/dl) | Four weeks after enrollment | ||
Secondary | Normalization of ALT, AST, CRP and ESR | Four weeks after enrollment | ||
Secondary | Symptom resolution & return to normal physical activity | Eight weeks after enrollment | ||
Secondary | In AVH patients with specific etiologies resolution of clinical signs and symptoms | Eight weeks after enrollment | ||
Secondary | Persistence of acute HCV with progression to chronicity | Up to 6 months after enrollment |
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