A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

NCT05788588 | Unknown Phase 3

• 1 other identifier: HR19006-301
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Serum prealbumin level on the 6th day after operation.

  on day 6 postoperation

Secondary Outcomes (10)

• The change of serum prealbumin level from baseline on the 6th day after operation.

  on days 1 and 6 post operation

• The changes of linoleic acid level from baseline on the 6th day after operation.

  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 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

Study Arms (2)

HR19006

EXPERIMENTAL

Drug: HR19006

All-in-one parenteral nutrition

ACTIVE COMPARATOR

Drug: All-in-one parenteral nutrition

Interventions

HR19006 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.

HR19006

All-in-one parenteral nutrition 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).

All-in-one parenteral nutrition

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent;
• Elective operation of Gastrointestinal;
• Male or female，aged 18-80 years inclusive;
• Body Weight at least 40kg, Body mass index (BMI) 18.5-30 kg/m2 inclusive;
• Nutrition Risk Screening (NRS2002) score at least 3 points.

You may not qualify if:

• Known hypersensitivity to egg-, soy-, and fish proteins or any of the ingredients;
• Congenital amino acid metabolism abnormality;
• Hypothyroidism or hyperthyroidism;
• Significant abnormal values of clinical laboratory examination;
• Uncompensated hemodynamical failure of any origin (hemorrhagic shock, myocardial infarction, cardiac failure);
• General contraindications for infusion therapy such as acute pulmonary oedema, hyper-hydration and decompensated cardiac insufficiency;
• Subjects with a history of mental system diseases and cognitive dysfunction;
• Serious complications during or after operation;
• Previous (\< 2 weeks) received treatment with intravenous nutrition;
• Previous (\< 4 weeks) or ongoing treatment with growth hormone or corticosteroids;
• Pregnant or nursing women;
• No birth control during the specified period of time;
• Participated in clinical trials of other drugs (received experimental drugs);
• The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Hefei First People's Hospital

Hefei, Anhui, 230061, China

Location

MeSH Terms

Conditions

Hyperphagia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: April 28, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-03

Locations

CN (1)