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Hepatitis C, ChronicPhase 2/3HEPASILNCT01871662

Randomized Study for the Assessment of Silibinin (Legalon® SIL) in the Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C

A Phase 2/3 study testing Legalon® SIL (Silibinin), Pegylated interferon alfa2b and Ribavirin in people with Hepatitis C, Chronic, run by Rottapharm at 1 site in Egypt.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to explore whether silibinin plus ribavirin with/without peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4. Read more about this study

Who is it for?
Ages 21 to 45 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Legalon® SIL (Silibinin), Pegylated interferon alfa2b and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteEgypt
Study dates
Aug 2013to Feb 2016
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 21 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient must be willing to give written informed consent
  • Male and female patients; age between 21 and 45 years inclusive
  • Chronic hepatitis C infection with genotype 4 confirmed by genotypic testing at screening or within 6 months of screening period
  • Patients eligible to be treated with RBV and Peg-IFN as per the instructions present in their prescribing information documents
  • No history of prior interferon therapy (treatment naïve)
  • Detectable HCV-RNA levels
  • Normal BUN and creatinine
  • Ability to communicate, participate, and comply with the requirements of the entire study

Who cannot join

  • Liver transplant patients
  • Co-Infection with HIV and/or HBV
  • ALT >10-fold the upper limit of normal i.e. > 400 U/L
  • Evidence of hepatocellular carcinoma (HCC)
  • Fibroscan® at screening with a score ≥ 14.5 kPa
  • Evidence of liver disease due to causes other than chronic HCV infection
Show all 20Show fewer
  • Evidence of poorly controlled diabetes (defined as HbA1c > 8%)
  • History of alcohol or drug abuse within the last 12 months
  • History or clinical evidence of liver decompensation, e.g. presence of ascites or encephalopathy, or bleeding from esophageal varices
  • Serum albumin levels < 3.2 g/dL
  • INR > 1.3 N
  • Total Bilirubin levels > 2.0 mg/dL unless explained by Gilbert's disease
  • Platelet Count < 100,000 µL
  • Absolute Neutrophil counts < 1500 µL (mm3)
  • Active or suspected non-hepatic malignancy or history of malignancy within the last 5 years
  • Body Mass Index < 16 or > 35 kg/m2
  • Females of childbearing potential:
  • Pregnancy (i.e. positive urine pregnancy test at screening) or lactation
  • Failure to agree to practice adequate contraception methods (e.g. oral contraceptives, intra-uterine device (IUD), transdermal contraceptive patch)
  • Male patients not vasectomized, who do not agree to abstain from intercourse or who do not use a condom

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Al-Manial University Hospital, Kasr El-Aini Faculty Medicine, Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: A Randomized, Single Center, Comparative Study to Evaluate the Efficacy and Safety of Silibinin (Legalon® SIL) in Combination With Ribavirin or With Peginterferon and Ribavirin, Versus Peginterferon and Ribavirin Based Standard of Care (SoC) in Treatment of naïve Genotype 4 Patients With Chronic Hepatitis C

The purpose of this study is to explore whether silibinin plus ribavirin with/without peg-interferon can be more effective than the peg-interferon plus ribavirin based standard of care (SoC) in the treatment of patients infected with hepatitis C virus genotype 4.

Being tested
Legalon® SIL (Silibinin), Pegylated interferon alfa2b, Ribavirin
Keywords
HCV, Hepatitis C
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

What participants receive

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

  • Legalon® SIL (Silibinin)Drug

    Silibinin 20 mg/Kg/day

  • Pegylated interferon alfa2bDrug

    Also called PEG-INTRON®

    1.5 µg/kg once-weekly

  • RibavirinDrug

    Also called REBETOL®

    At weight-based dose 800-1400 mg/day (BID, OS)

Study groups in NCT01871662
Study groupRoleWhat they receive
Group C: RIB + Peg-IFNActive comparatorRibavirin(800-1400 mg/day,divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC)for 25 weeks if RVR has been achieved or 49 weeks if EVR has been achieved
Receives: Drug: Pegylated interferon alfa2b; Drug: Ribavirin
Group B:Legalon® SIL + RIB + Peg-IFNExperimentalSilibinin (20 mg/Kg/day) for 6 days, followed by Silibinin + ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) for 15 days, followed by ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) + 2 days of Silibinin per week for 9 weeks, followed by ribavirin (800-1400 mg/day, divided BID PO) + Peg-IFN alfa2b (1.5 μg/kg/week SC) for 13 weeks if RVR has been achieved (for a total of 25 weeks of treatment) or 37 weeks if EVR has been achieved (for a total of 49 weeks of treatment)
Receives: Drug: Legalon® SIL (Silibinin); Drug: Pegylated interferon alfa2b; Drug: Ribavirin
Group A: Legalon® SIL + RIBExperimentalSilibinin (20 mg/Kg/day) for 6 days, followed by Silibinin + ribavirin (800-1400 mg/day, divided BID PO) for 15 days, followed by ribavirin (800-1400 mg/day, divided BID PO) + 2 days of Silibinin per week for 9 weeks, followed by ribavirin (800-1400 mg/day, divided BID PO) for 13 weeks if RVR has been achieved (for a total of 25 weeks of treatment) or 37 weeks if EVR has been achieved (for a total of 49 weeks of treatment)
Receives: Drug: Legalon® SIL (Silibinin); Drug: Ribavirin

What is being measured

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

  1. Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment

    The primary efficacy endpoint is the proportion of patients with Sustained Virological Response (SVR), i.e. undetectable HCV-RNA level lasting for 24 weeks after the completion of the study treatment course.

    Measured: 24 weeks after the end of treatment (e.g. at week 49 or 73)

Secondary outcomes (5)

  1. Undetectable HCV-RNA

    Proportion of patients with Rapid Viral Response (RVR), i.e. undetectable HCV-RNA levels 4 weeks after the beginning of the study treatment course.

    Measured: 4 weeks after the beginning of the study treatment

  2. HCV-RNA decrease ≥ 2 log10 IU/mL

    Number and percentage of patients with Early Viral Response (EVR), i.e. HCV-RNA decrease ≥ 2 log10 IU/mL 12 weeks after the beginning of the study treatment course

    Measured: 12 weeks after the beginning of the study treatment

  3. Undetectable HCV-RNA

    Proportion of patients with End Of Treatment (EOT) Response, i.e. undetectable HCV-RNA levels at the end of the study treatment (e.g. at the end of treatment at week 25 or 49)

    Measured: At the end of study treatment (e.g. at week 25 or 49)

  4. Normalization of Serum Alanine Aminotransferase

    Proportion of patients with a normalization of Serum Alanine Aminotransferase (ALT <40 U/L) values 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment course;

    Measured: 4 weeks after the beginning of study treatment, at EOT and at 24 weeks after the completion of the study treatment

  5. Number of Participants with adverse events (AEs)

    Measured: Up to 24 weeks after the end of treatment (e.g. up to week 49 or 73)

Timeline

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

  1. First posted7 Jun 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionFeb 2016 (estimated)
  4. Study completionFeb 2016 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871662
Sponsor's protocol ID
LEG-SIL-2-02
Acronym
HEPASIL
Status last verified
Mar 2015
First submitted
30 May 2013
Last updated
5 Mar 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Legalon® SIL (Silibinin), Pegylated interferon alfa2b and Ribavirin in people with Hepatitis C, Chronic, run by Rottapharm at 1 site 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 8 inclusion and 20 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: withdrawn, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 withdrawn before enrolling participants, so there are no results.

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?

Undetectable HCV-RNA at 24 Weeks After the end of the Study Treatment (time frame: 24 weeks after the end of treatment (e.g. at week 49 or 73)). 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 NCT01871662.

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 5 Mar 2015.

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