A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

Phase 3

Active, not recruiting

• Conditions: Parenteral Nutrition
• Interventions: Drug: All-in-one parenteral nutrition; Drug: HR19006

• Registration Number: NCT05788588
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-29
• Study Start: 2023-04-28
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-10
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
All-in-one parenteral nutrition	All-in-one parenteral nutrition	-
HR19006	HR19006	-

Primary Outcome Measures

Name	Time	Method
Serum prealbumin level on the 6th day after operation.	on day 6 postoperation

Secondary Outcome Measures

Name	Time	Method
The changes of linoleic acid 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 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 TNF-α level from baseline on the 6th day after operation.	on days 1 and 6 post operation
The change of serum prealbumin 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
The changes of arachidonic acid 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

Trial Locations

Locations (1)

Hefei First People's Hospital; 🇨🇳 Hefei, Anhui, China