A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

Study Overview
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Brief Summary
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This is a phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory study, and the purpose of the study is to evaluate the efficacy and safety of HR190006 for postoperative parenteral nutrition via central venous catheter.

Official Title
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A Multi-center, Randomized, Single-blind, Parallel Controlled With Active Drug, Confirmatory Study to Evaluate the Efficacy and Safety of HR19006 Injection for Postoperative Parenteral Nutrition

Conditions
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Parenteral Nutrition

Intervention / Treatment
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* Drug: HR19006
* Drug: All-in-one parenteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide a written informed consent; Elective operation of Gastrointestinal; Male or female，aged 18-80 years inclusive; Body Weight at least 40kg, Body mass index (BMI) 18.5-30 kg/m2 inclusive; Nutrition Risk Screening (NRS2002) score at least 3 points. Exclusion Criteria: Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients; Congenital amino acid metabolism abnormality; Hypothyroidism or hyperthyroidism; Significant abnormal values of clinical laboratory examination; Uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure); General contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency; Subjects with a history of mental system diseases and cognitive dysfunction; Serious complications during or after operation; Previous (< 2 weeks) received treatment with intravenous nutrition; Previous (< 4 weeks) or ongoing treatment with growth hormone or corticosteroids; Pregnant or nursing women; No birth control during the specified period of time; Participated in clinical trials of other drugs (received experimental drugs); The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HR19006<br> | Drug: HR19006<br>* An emulsion containing the full supply of carbohydrates, amino acids and lipids with a total energy content of 1265kcal in a 1250 ml volume, administered via a central venous line over a time period of approximately 15 hours per day.<br>|
| Active Comparator: All-in-one parenteral nutrition<br> | Drug: All-in-one parenteral nutrition<br>* Trial participants are prescribed TPN by the attending physician, which will be administered via a central venous line over a time period of approximately 15 hours per day. The formulation is an emulsion containing the full supply of carbohydrates, amino acids and lipids with a total energy content of 1265kcal in a 1250 ml volume (nitrogen content, heat and liquid quantity as equal as HR19006).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum prealbumin level on the 6th day after operation. |  | on day 6 postoperation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of serum prealbumin level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of linoleic acid level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of arachidonic acid level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of linolenic acid level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of EPA level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of DHA level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of CRP level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of IL-6 level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The changes of TNF-α level from baseline on the 6th day after operation. |  | on days 1 and 6 post operation | 
| The incidence of new postoperation infection. |  | on days 1 and 6 post operation |