The product is aimed to be used where parenteral nutrition is required. The intended indication is: Supply of essential and non-essential amino acids as part of Parenteral Nutrition for infants and children, when oral or enteral nutrition is impossible, insufficient or contraindicated. MedDRA version: 12.1 Level: LLT Classification code 10051284 Term: Parenteral nutrition
Conditions
Interventions
Product Name: NEOVEN
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Acetylcysteine
CAS Number: 616-91-1
Current Sponsor
Sponsors
Fresenius Kabi Deutschland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Sex: Male or female - Age: 1 month to 11 years - Patients with intestinal malabsorption requiring parenteral nutrition (PN) at a minimum of 50% recommended daily amount (RDA) of total energy intake - Expected stable disease requiring PN for at least 12 weeks such as short bowel syndrome, severe gastrointestinal obstruction, chronic intestinal pseudo obstruction, congenital enteropathy - In case of PN infusion before inclusion: Permanent use of the same lipid emulsion for 16 weeks, starting 4 weeks prior to study inclusion and continued during study treatment period of 12 weeks - Minimum of 4 days of PN infusion per week - Legal representative(s) signed informed consent - Assent obtained from patients above 7 years of age Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Absence of vascular access - Patients requiring parenteral nutrition (PN) less than 50% RDA of total energy intake - Insufficient renal function with serum creatinine of = 2.0 mg/dl (= 120µmol/L) or receiving dialysis/hemofiltration therapy - Severe liver dysfunction (with either ammonia levels > 150 µmol/l or total S-Bilirubin > 200µmol/l and S-ALAT >200lU/l) - Cirrhosis documented by histology - Severe metabolic acidosis with Bicarbonate < 17 mmol/l, non-transient - Inborn errors of amino acid metabolism - Any other detectable metabolic disorders, if known at the time point of inclusion - Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus with or without insulin treatment, severe sepsis and hypotonic dehydration) - General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency. - Thrombocytopenia: platelets <50x10^9/l - Cancer, chemotherapy, radiation therapy - Concomitant anticoagulant, steroid or immunosuppressive therapy - Suspected allergy to the study medication - Patients with psychiatric diseases, epilepsy - Participation in another clinical study with an investigational drug or an investigational medical device within one month prior to start of study or during the study - Prior inclusion in the present study - Any other feature that in the opinion of the investigator should preclude study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study should give information on the long-term use of Neoven in infants and children. The main focus of the study will be to examine a variety of parameters including hyperammonemia, metabolic acidosis, azotemia, hyperaminoacidemia, hyperglycemia and hepatic function/dysfunction (Ammonia, AST, ALT, AP, GGT, bilirubin levels). All of these parameters will be based on changes in laboratory evaluations from baseline including laboratory parameters relevant for cholestasis, i.e., conjugated (direct) bilirubin, alkaline phosphatase (AP), and gamma-GT (GGT). The main objective is to evaluate the safety of Neoven compared to Vaminolact in infants and children requiring long-term parenteral nutrition. ; Secondary Objective: The secondary objective is to evaluate the efficacy of Neoven compared to Vaminolact in infants and children requiring long-term parenteral nutrition. Of specific importance are the infection rate, the incidence of sepsis, the duration and severity of diarrhoea, the Amino acid profiles, anthropometry (weight, height), Albumin and Pre-Albumin, IGF-1 and IGFBP-3 level and Adverse Events. ; Primary end point(s): - Hyperammonemia - Metabolic acidosis - Azotemia - Hyperaminoacidemia - Hyperglycemia - Hepatic function/dysfunction as measured by ammonia, AST, ALT, AP, GGT, and bilirubin | — |
Countries
France
Outcome results
None listed