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Hepatic and Hepatobiliary DisordersPhase 3EPLIDNCT02517385

Essentiale® Paste in Patients With Gastrointestinal Symptoms in Acute or Chronic Liver Diseases

A Phase 3 study testing Phosphatidylcholine in people with Hepatic and Hepatobiliary Disorders, run by Sanofi at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases. Read more about this study

Who is it for?
Ages 18 to 66 years
Conditions the study is for
Hepatic and Hepatobiliary Disorders
What is being tested?
Phosphatidylcholine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
1 siteRussia
Study dates
Aug 2015to Jun 2016
Phase
Phase 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 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females ≥18 years of age and less than 66 years old.
  • Patients with gastrointestinal symptoms (fatigue, abdominal pain/discomfort, early satiety, fullness discomfort after meal, nausea/vomiting, belching/abdominal distension, at least one rated as "Moderate Problem" or higher severity at screening visit) in acute and chronic liver diseases receiving conventional treatment for the underlying pathology.
  • Before entering the study, patients will be advised to stop alcohol intake and must agree not to consume alcohol and undergo alcohol withdrawal program, diet control, and exercise program.
  • The patient is able and willing to undertake all study required procedures and has the ability to take oral medications.
  • Patients with nonalcoholic fatty liver disease (NAFLD) diagnosed by ultrasound examination in absence of severe fibrosis as per Investigator's judgment.
  • Diagnosis of acute or chronic viral hepatitis as manifested by a combination of the following symptoms: jaundice (acute viral hepatitis), dark-colored urine (acute viral hepatitis), light-colored stools (acute viral hepatitis), pruritus, pruritic red hives, fever, nausea, vomiting, anorexia, aversion to smoking and right upper abdominal discomfort, pain or feeling of pressure, with abnormal alanine aminotransferase (ALT) (approximately 1.5 x upper limit of normal [ULN]).
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  • Patient has given written informed consent.
  • Fertile patients must agree to use an acceptable method of contraception to avoid pregnancy for the duration of the study:
  • Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration).
  • Vasectomized partner of female subjects.
  • Hormonal contraceptives.
  • Double-barrier method (condoms and diaphragm or vaginal cap plus spermicidal sponge, jellies, or cream).
  • Intrauterine Device (IUD).

Who cannot join

  • Patients <18 years of age and >66 years old.
  • Female patient of childbearing potential without negative pregnancy test.
  • Breastfeeding woman.
  • Hypersensitivity to phosphatidylcholine or any substance of the product.
  • Patient is known to be human immunodeficiency virus (HIV) positive.
  • Congenital lack of α-1 antitrypsin.
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  • Gastroesophageal Reflux Disease (GERD).
  • Autoimmune hepatitis.
  • Fulminant hepatitis.
  • Severe steatohepatitis: transaminases level is beyond 5 times upper normal range.
  • Previous liver biopsy that demonstrated greater than or equal to 15% steatosis.
  • Evidence of decompensated liver disease defined as any of the following: serum albumin <3.2 g/dL, total bilirubin >1.5 mg/dL, or prothrombin time/international normalized ratio >1.3 times normal at screening, or history or presence of ascites or encephalopathy, or bleeding from esophageal varices.
  • Diagnosis of cancer.
  • Parenteral nutrition.
  • Advanced liver disease (eg, ascites, bleeding esophageal varices, hepatic encephalopathy, cancer or hepatic metastasis).
  • History of other serious chronic liver disease, including serious metabolic diseases, documented by appropriate test(s).
  • Evidence of upper abdomen organic serious diseases (ulcer, etc.).
  • Platelet count <130 000 cells/mm^3.
  • Serum creatinine level >1.5 times the upper limit of normal at screening, or creatinine clearance <60 cc/min, or currently on dialysis.
  • History of drug abuse within a year prior to Day 0.
  • Current or recent use (within 15 days of screening) of any hepatoprotector drug.
  • Use of warfarin, metronidazole, or chronic use of acetaminophen/paracetamol greater than three grams per day.
  • Use of oral steroids within 30 days prior to screening.
  • Use of concomitant medication disturbing the liver function or CYP3A4 inducers.
  • Patients who have taken drugs able to induce fatty liver for over 3 months within 1 year of participation in this study; (ie, amiodarone, tamoxifen, methotrexate, tetracyclines, glucocorticoids, over usual dose of estrogen for hormone replacement therapy, valproate, St. John's Wort, etc.).
  • Patients who have taken any medications that could affect the treatment for nonalcoholic steatohepatitis: insulin, insulin sensitizer (ie, metformin, thiazolidinedione, high dose of vitamin E, high dose of ursodeoxycholic acid, pentoxifylline, S-adenosyl methionine, betaine, types of statin, types of fibrate, orlistat, etc.).
  • History of solid organ or bone marrow transplantation.
  • History and current immunologically mediated disease (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hepatitis, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis, polyorganic pathology) that could affect inflammatory biomarkers.
  • History and current thyroid disease poorly controlled on prescribed medications.
  • History and current significant renal, endocrine, cardiac, or pulmonary disease.
  • Other serious liver diseases or systemic pathologies (malignancies, central nervous system). Some examples are severe hypertension, morbid obesity (body mass index >40), severe mental illness, diabetes type 1, and poorly controlled diabetes type 2.
  • Other conditions which, in the Investigator's opinion, make the patient unsuitable for enrollment (such as coronary artery disease or active gastrointestinal conditions that might interfere with drug absorption).
  • The patient is currently participating in any clinical trial (marketed product or otherwise) or has done so within 30 days prior to screening visit.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Study site

    Moscow

Other trials in Russia

About this study

Official title: Multicenter Prospective Uncontrolled Non-comparative Open Interventional Clinical Study of Phase III for Assessment of the Safety and Effectiveness of Using the Drug Phosphatidylcholine Paste 600 mg in Patients With Acute and Chronic Liver Diseases and Clinical Symptoms of Dysfunction of the Gastrointestinal Tract During 12-week Therapy Course

Primary Objective:

To assess safety of Phosphatidylcholine paste 600 mg (ESSENTIALE® paste) oral 3 times a day for 12 weeks in patients with gastrointestinal symptoms in acute and chronic liver diseases.

Secondary Objectives:

To assess effectiveness on symptomatic improvement in patients with gastrointestinal symptoms in acute and chronic liver diseases.

To monitor compliance.

Read the detailed description

The total study duration per patient will be 13 weeks that consists of 1-week pre-screening period and a 12-week treatment period.

Being tested
Phosphatidylcholine
Medical subject headings
Digestive System Diseases

What participants receive

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

  • PhosphatidylcholineDrug

    Pharmaceutical form:Paste Route of administration: Oral

Study groups in NCT02517385
Study groupRoleWhat they receive
Phosphatidylcholine pasteExperimentalOne dose of phosphatidylcholine paste 600 mg given orally 3 times a day at Days 0, 28, 56, and 84
Receives: Drug: Phosphatidylcholine

What is being measured

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

  1. Frequency (number) of adverse events (AEs) related to the investigational drug

    Measured: Week 12

Secondary outcomes (5)

  1. Change from baseline in patient percentage of global overall symptoms using Likert Scale

    Measured: Weeks 4, 8, and 12

  2. Change from baseline in gastrointestinal symptom percentage score

    Measured: Weeks 4, 8, and 12

  3. Percentage of patients with AEs regardless of the Investigator's assessment of relationship to the investigational drug

    Measured: Weeks 4, 8, and 12

  4. Number of AEs regardless of the Investigator's assessment of relationship to the investigational drug

    Measured: Weeks 4, 8, and 12

  5. Number of patients who complied with the prescribed treatment

    Measured: Weeks 4, 8, and 12

Timeline

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

  1. First posted7 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02517385
Sponsor's protocol ID
CHOLIL06301
Other IDs
U1111-1131-0460
Acronym
EPLID
Status last verified
Jul 2016
First submitted
20 Jul 2015
Last updated
4 Jul 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Phosphatidylcholine in people with Hepatic and Hepatobiliary Disorders, run by Sanofi at 1 site in Russia.

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 13 inclusion and 34 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: finished, as of the sponsor's last update on 4 Jul 2016. 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 Russia. 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 phase mean?

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Frequency (number) of adverse events (AEs) related to the investigational drug (time frame: Week 12). 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 NCT02517385.

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 4 Jul 2016.

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