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

NCT02517385 | Completed Phase 3

• 2 other identifiers: CHOLIL06301U1111-1131-0460
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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. Secondary Objectives: To assess effectiveness on symptomatic improvement in patients with gastrointestinal symptoms in acute and chronic liver diseases. To monitor compliance.

Conditions

Hepatic and Hepatobiliary Disorders

Outcome Measures

Primary Outcomes (1)

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

  Week 12

Secondary Outcomes (5)

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

  Weeks 4, 8, and 12

• Change from baseline in gastrointestinal symptom percentage score

  Weeks 4, 8, and 12

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

  Weeks 4, 8, and 12

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

  Weeks 4, 8, and 12

• Number of patients who complied with the prescribed treatment

  Weeks 4, 8, and 12

Study Arms (1)

Phosphatidylcholine paste

EXPERIMENTAL

One dose of phosphatidylcholine paste 600 mg given orally 3 times a day at Days 0, 28, 56, and 84

Drug: Phosphatidylcholine

Interventions

Phosphatidylcholine DRUG

Pharmaceutical form:Paste Route of administration: Oral

Phosphatidylcholine paste

Eligibility Criteria

• Age: 18 Years - 66 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[ULN\]).
• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Unknown Facility

Moscow, Russia

Location

MeSH Terms

Conditions

Digestive System Diseases

Interventions

Phosphatidylcholines

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 7, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2016-07

Locations

RU (1)