A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05788588
• Collaborator: (none)
• Enrollment: 240
• Arms: 2
• Anticipated Duration (Months): 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parenteral Nutrition	Drug: HR19006; Drug: All-in-one parenteral nutrition	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Anticipated Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HR19006	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.
Active Comparator: All-in-one parenteral nutrition	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).

Outcome Measures

Primary Outcome Measures

1. Serum prealbumin level on the 6th day after operation. [on day 6 postoperation]

Secondary Outcome Measures

1. The change of serum prealbumin level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

2. The changes of linoleic acid level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

3. The changes of arachidonic acid level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

4. The changes of linolenic acid level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

5. The changes of EPA level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

6. The changes of DHA level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

7. The changes of CRP level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

8. The changes of IL-6 level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

9. The changes of TNF-α level from baseline on the 6th day after operation. [on days 1 and 6 post operation]

10. The incidence of new postoperation infection. [on days 1 and 6 post operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fujian Shengdi Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05788588
• Other Study ID Numbers: HR19006-301
• First Posted: Mar 29, 2023
• Last Update Posted: Mar 29, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 29, 2023