A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parenteral Nutrition
• Intervention / Treatment: Drug: HR19006; Drug: All-in-one parenteral nutrition

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qin Liu; Phone Number: +0518-82342973; Email: qin.liu@hengrui.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230061
      • Hefei First People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Elective operation of Gastrointestinal;
3. Male or female，aged 18-80 years inclusive;
4. Body Weight at least 40kg, Body mass index (BMI) 18.5-30 kg/m2 inclusive;
5. Nutrition Risk Screening (NRS2002) score at least 3 points.

Exclusion Criteria:

1. Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients;
2. Congenital amino acid metabolism abnormality;
3. Hypothyroidism or hyperthyroidism;
4. Significant abnormal values of clinical laboratory examination;
5. Uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure);
6. General contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency;
7. Subjects with a history of mental system diseases and cognitive dysfunction;
8. Serious complications during or after operation;
9. Previous (< 2 weeks) received treatment with intravenous nutrition;
10. Previous (< 4 weeks) or ongoing treatment with growth hormone or corticosteroids;
11. Pregnant or nursing women;
12. No birth control during the specified period of time;
13. Participated in clinical trials of other drugs (received experimental drugs);
14. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HR19006	Drug: HR19006; 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.
Active Comparator: All-in-one parenteral nutrition	Drug: All-in-one parenteral nutrition; 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Estimated): October 10, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HR19006-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No