A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

NCT ID: NCT05788588

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-28
• Study Completion Date: 2023-12-31

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.

Conditions

Parenteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

HR19006

Group Type: EXPERIMENTAL

HR19006

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

All-in-one parenteral nutrition

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hefei First People's Hospital

Hefei, Anhui, China

Countries

China

Other Identifiers

HR19006-301

Identifier Type: -

Identifier Source: org_study_id