Parenteral NutritionPhase 3NCT05788588
A Phase Ⅲ Study of HR19006 Injection in Postsurgical Parenteral Nutrition
A Phase 3 study testing HR19006 and All-in-one parenteral nutrition in people with Parenteral Nutrition, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parenteral Nutrition
- What is being tested?
- HR19006 and All-in-one parenteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 28 Apr 2023to 31 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- HR19006, All-in-one parenteral nutrition
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR19006Drug
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 nutritionDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| HR19006 | Experimental | Not described Receives: Drug: HR19006 |
| All-in-one parenteral nutrition | Active comparator | Not described Receives: Drug: All-in-one parenteral nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum prealbumin level on the 6th day after operation.
Measured: on day 6 postoperation
Secondary outcomes (10)
The change of serum prealbumin level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of linoleic acid level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of arachidonic acid level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of linolenic acid level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of EPA level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of DHA level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of CRP level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of IL-6 level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The changes of TNF-α level from baseline on the 6th day after operation.
Measured: on days 1 and 6 post operation
The incidence of new postoperation infection.
Measured: on days 1 and 6 post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start28 Apr 2023
- Primary completion30 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parenteral NutritionStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788588
- Sponsor's protocol ID
- HR19006-301
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05788588
- Acronym / sponsor ID
- HR19006-301
- Conditions
- Parenteral Nutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase Ⅲ, multi-center, randomized, single-blind, parallel controlled with active drug, confirmatory clinical trial.
| Arm | Type | Receives |
|---|---|---|
| HR19006 | Experimental | Drug: HR19006 |
| All-in-one parenteral nutrition | Active comparator | Drug: All-in-one parenteral nutrition |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR19006An 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. | Drug | HR19006 |
| All-in-one parenteral nutritionTrial 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). | Drug | All-in-one parenteral nutrition |
Primary outcome
Serum prealbumin level on the 6th day after operation.
Time frame: on day 6 postoperation
10 secondary outcomes
The change of serum prealbumin level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of linoleic acid level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of arachidonic acid level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of linolenic acid level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of EPA level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of DHA level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of CRP level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of IL-6 level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The changes of TNF-α level from baseline on the 6th day after operation.
Time frame: on days 1 and 6 post operation
The incidence of new postoperation infection.
Time frame: on days 1 and 6 post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HR19006 and All-in-one parenteral nutrition in people with Parenteral Nutrition, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum prealbumin level on the 6th day after operation. (time frame: on day 6 postoperation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.