A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

Parenteral Nutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05788588
• Other study ID #: HR19006-301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 28, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parenteral Nutrition

Intervention

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.
• 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).

Locations

Country	Name	City	State
China	Hefei First People's Hospital	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum prealbumin level on the 6th day after operation.		on day 6 postoperation
Secondary	The change of serum prealbumin level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of linoleic acid level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of arachidonic acid level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of linolenic acid level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of EPA level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of DHA level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of CRP level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of IL-6 level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The changes of TNF-a level from baseline on the 6th day after operation.		on days 1 and 6 post operation
Secondary	The incidence of new postoperation infection.		on days 1 and 6 post operation