A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

Fujian Shengdi Pharmaceutical

Status and phase: Active, not recruiting; Phase 3

Conditions: Parenteral Nutrition

Treatments: Drug: All-in-one parenteral nutrition; Drug: HR19006

Study type: Interventional

Funder types: Industry

Identifiers

NCT05788588

HR19006-301

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 2 patient groups

HR19006

Experimental group

Treatment:

Drug: HR19006

All-in-one parenteral nutrition

Active Comparator group

Treatment:

Drug: All-in-one parenteral nutrition