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Acute Hepatitis APhase 2/3NCT00755950

Randomized Placebo-controlled Trial Evaluating the Safety and Efficacy of Silymarin Treatment in Patients With Acute Viral Hepatitis

A Phase 2/3 study testing Silymarin and Lactose monohydrate in people with Acute Hepatitis A and Acute Hepatitis B, run by University of Maryland, Baltimore at 3 sites in Egypt.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Silymarin and Lactose monohydrate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
3 sitesEgypt
Study dates
Oct 2008to Dec 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country.

Egypt3 sites

  • Alexandria University Hospital

    Alexandria, Alexandria Governorate

  • Banha Fever Hospital

    Banhā, Kaluobeya Governorate

  • Tanta Fever Hospital

    Tanta, Gharbeya Governorate

Other trials in Egypt

About this study

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

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.

Read the detailed description

Currently, acute viral hepatitis (AVH) management is based on diet and rest and silymarin remains among the most popular herbs being used for treating viral hepatitis both in the U.S. and abroad. Although numerous randomized clinical trials have been conducted to assess the efficacy of silymarin on chronic hepatitis C, very few studies were done to assess the efficacy of silymarin in acute viral hepatitis. Among those, efficacy of silymarin has not been established. This could be attributed to the small number of studies conducted, small sample sizes, high drop out rates, and low doses of silymarin used. Therefore, it is justified to evaluate silymarin safety and efficacy using higher doses than previously studied in AVH.

Primary safety objective:

  • To assess safety and tolerability of two silymarin doses in patients with AVH as determined by the number and percentage of subjects who develop Adverse Events in each group elicited by a questionnaire administered at specific visits and by hematology, blood chemistry and physical examinations.

Primary efficacy objective:

  • To assess the percentage of subjects who normalize their total and direct bilirubin in each group.

Secondary Objective:

To assess the percentage of subjects in each group who:

  • Normalize their liver enzymes, i.e. alanine aminotransferase (ALT), aspartate aminotransferase (AST) and inflammatory reactants, i.e. erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
  • Resolve their clinical symptoms of AVH and return to baseline activity levels and quality of life (QOL) assessed by physical examinations and using a previously evaluated Arabic-translated SF-36 form adapted for use with patients with liver diseases.

To assess:

  • Differences in silymarin response in different AVH etiologies (i.e. HAV, HBV, HCV, HEV) using subgroup analyses.

To compare:

  • Progression of acute to chronic HCV infection in subjects with HCV-caused acute AVH.
Being tested
Silymarin, Lactose monohydrate
Keywords
Acute, Hepatitis, Silymarin, Global Health
Medical subject headings
Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SilymarinDietary supplement

    Also called Legalon, Milk Thistle or St. Mary's Thistle

    280 mg three times daily for four weeks

  • SilymarinDietary supplement

    Also called Legalon, Milk Thistle or St. Mary's Thistle

    420 mg three times daily for four weeks

  • Lactose monohydrateOther

    Lactose monohydrate 326.95 mg three times daily for four weeks

Study groups in NCT00755950
Study groupRoleWhat they receive
1Experimental280 mg of Silymarin administered three times daily for 4 weeks; Vitamin B complex: B1:thiamine (1.3mg), B2:riboflavin (1.0mg) and B3: nicotinamide (16.5mg)
Receives: Dietary Supplement: Silymarin
3Placebo comparatorPlacebo: Lactose monohydrate; Vitamin B complex: B1:thiamine (1.3mg), B2:riboflavin (1.0mg) and B3: nicotinamide (16.5mg)
Receives: Other: Lactose monohydrate
2.Experimental420 mg silymarin three times daily for four weeks; Vitamin B complex: B1:thiamine (1.3mg), B2:riboflavin (1.0mg) and B3: nicotinamide (16.5mg)
Receives: Dietary Supplement: Silymarin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence, severity and duration of Adverse Events

    Measured: Four weeks after enrollment

  2. Normalization of total (<1.0 mg/dl) and direct bilirubin (<0.3 mg/dl)

    Measured: Four weeks after enrollment

Secondary outcomes (4)

  1. Normalization of ALT, AST, CRP and ESR

    Measured: Four weeks after enrollment

  2. Symptom resolution & return to normal physical activity

    Measured: Eight weeks after enrollment

  3. In AVH patients with specific etiologies resolution of clinical signs and symptoms

    Measured: Eight weeks after enrollment

  4. Persistence of acute HCV with progression to chronicity

    Measured: Up to 6 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionNov 2011
  4. Study completionDec 2015

Why it stopped: Low enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00755950
Sponsor's protocol ID
HP-00042363
Other IDs
LE13K0.48
Status last verified
Apr 2021
First submitted
17 Sep 2008
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Silymarin and Lactose monohydrate in people with Acute Hepatitis A and Acute Hepatitis B, run by University of Maryland, Baltimore at 3 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence, severity and duration of Adverse Events (time frame: Four weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00755950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

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