Clinical trial NCT05788588: A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Parenteral Nutrition
Lead sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Serum prealbumin level on the 6th day after operation.
timeFrame: on day 6 postoperation
Secondary outcomes:
measure: The change of serum prealbumin level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of linoleic acid level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of arachidonic acid level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of linolenic acid level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of EPA level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of DHA level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of CRP level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of IL-6 level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The changes of TNF-α level from baseline on the 6th day after operation.
timeFrame: on days 1 and 6 post operation
measure: The incidence of new postoperation infection.
timeFrame: on days 1 and 6 post operation
Other outcomes:
Locations:
city: Hefei
country: China
facility: Hefei First People's Hospital
state: Anhui
Study officials:
References: