Chronic Heart FailurePhase 3NCT01214096
Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
A Phase 3 study testing rhNRG-1 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 4 sites in China.
Trial summary
Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- rhNRG-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 4 sitesChina
- Study dates
- Jul 2010to Jan 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old, no limitation in gender;
- Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO);
- Patients with chronic heart failure (NYHA class II or III);
- In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable;
- Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month;
- Understand and sign the informed consent form;
Who cannot join
- Atrial fibrillation;
- Subject underwent cardiac pacemaker treatment;
- Subject underwent metal graft treatment;
- Claustrophobia;
- Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension;
- Ischemic heart failure without the revascularization or undergone the revascularization within last 6 months;
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- Subject underwent cardiac surgery or cerebrovascular events within the previous six months;
- Subjects who plan to have cardiac transplantation;
- Severe hepatic and renal insufficiency (serum creatinine>2.0 mg /dl, AST or ALT is five times higher than the upper limit of normal range);
- Subject needs mechanical ventilation;
- Systolic blood pressure < 90mmHg, or > 160mmHg;
- Chronic heart failure complicated with acute hemodynamic disturbance or acute decompensation within last 1 month;
- Mobitz Type II or III° atrial ventricular block，severe ventricular arrhythmia (polymorphic and frequent premature ventricular beats, frequent non-sustained ventricular tachycardia);
- Serum potassium<3.2mmol/L, or>5.5mmol/L;
- Female subject is pregnant or plan to become pregnant
- Childbearing-aged female subject who is unmarried or dose not bear child;
- Subject with life expectancy less than 6 months as assessed by investigators;
- Subject participated in any other clinical trial within the previous three months;
- Subject with previous history of tumor, or current tumor patient, or subject with pre-cancerous disease manifested by pathological examination (such as ductal carcinoma in situ or cervical epithelial dysplasia)
- Examinations (physical examination, X-ray examination, type-B ultrasonic detection or other methods) reveal that the subject has malignant mass, gland hyperplasia or adenoma with endocrine activity, or impact on heart, or endocrine function (such as pheochromocytoma, thyroid enlargement);
- The Investigator deemed for whatever reason that the subject is not likely to complete the study or comply with the study procedures (due to administration or any other reason).
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Anzhen Hospital of Capital University of Medical Sciences
Beijing
Beijing Chaoyang Hospital, Capital Medical University
Beijing
Cardiovascular Institute & Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing
General Hospital of People's Liberation Army
Beijing
About this study
Official title: A Multi-center, Randomized, Double-blind , Placebo Parallel Controlled, Standard Therapy Based Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
Read the detailed description
- Subcutaneous Administration of NRG-1 is well tolerated by CHF patients
- Subcutaneous Administration of NRG-1 improves the cardiac function of CHF patients
- Assessment of relative bioavailability of NRG-1 by Subcutaneous Administration
- Conditions
- Chronic Heart Failure
- Being tested
- rhNRG-1, placebo
- Keywords
- Chronic Heart failure, rhNRG-1, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhNRG-1Drug
Subcutaneous Administration:0.6ug/kg/day for 10days
rhNRG-1Drug
Subcutaneous Administration 1.2ug/kg/day for 10 days
rhNRG-1Drug
Vein infusion:0.6ug/kg/day for 10 days
placeboDrug
Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| rhNRG-1 | Experimental | recombinant human neuregulin-1 Receives: Drug: rhNRG-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac function measured by MRI
Measured: 30 days
Secondary outcomes (1)
cardiac function
6-minute walk test, cardiac function classification(NYHA)，life quality score.
Measured: baseline, 30 days, 90day and180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: The same protocol has been launched in United States.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zensun Sci. & Tech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Runlin Gao, Principal investigator, Cardiovascular Institute and Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214096
- Sponsor's protocol ID
- ZS-01-302
- Status last verified
- Nov 2017
- First submitted
- 28 Sep 2010
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind , Placebo Parallel Controlled, Standard Therapy Based Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
- ClinicalTrials.gov ID
- NCT01214096
- Acronym / sponsor ID
- ZS-01-302
- Conditions
- Chronic Heart Failure
- Keywords
- Chronic Heart failure, rhNRG-1, MRI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The same protocol has been launched in United States.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Zensun Sci. & Tech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 4 Oct 2010 (estimated)
- 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.
Evaluate the Efficacy and Safety of Recombinant Human Neuregulin-1 for Subcutaneous Administration in Patients With Chronic Systolic Heart Failure
Detailed description
- Subcutaneous Administration of NRG-1 is well tolerated by CHF patients
- Subcutaneous Administration of NRG-1 improves the cardiac function of CHF patients
- Assessment of relative bioavailability of NRG-1 by Subcutaneous Administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| rhNRG-1 | Experimental | Drug: rhNRG-1recombinant human neuregulin-1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-75 years old, no limitation in gender;
- Left ventricular ejection fraction (LVEF) ≤ 40% (ECHO);
- Patients with chronic heart failure (NYHA class II or III);
- In the past one month, the clinical condition (including history, clinical symptoms and signs) was relatively stable;
- Patients on standard treatment of chronic heart failure at the target dose or maximum tolerance dose for over 1 month ,or unchanged dose in last 1 month;
Key exclusion criteria (21 listed)
- Atrial fibrillation;
- Subject underwent cardiac pacemaker treatment;
- Subject underwent metal graft treatment;
- Claustrophobia;
- Acute myocardial infarction, cardiac ischemia indicated by 6-minute walk test, hypertrophic cardiomyopathy, constrictive pericarditis, significant valve disease or congenital heart disease, severe pulmonary hypertension;
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 |
|---|---|---|
| rhNRG-1Subcutaneous Administration:0.6ug/kg/day for 10days | Drug | rhNRG-1 |
| rhNRG-1Subcutaneous Administration 1.2ug/kg/day for 10 days | Drug | rhNRG-1 |
| rhNRG-1Vein infusion:0.6ug/kg/day for 10 days | Drug | rhNRG-1 |
| placeboSubcutaneous Administration:0.6 or 1.2ug/kg/day for 10days | Drug | placebo |
Primary outcome
cardiac function measured by MRI
Time frame: 30 days
1 secondary outcome
cardiac function
Time frame: baseline, 30 days, 90day and180 days
Results and safety
The study was stopped early (reason given: The same protocol has been launched in United States.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2017.
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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.
Runlin Gao principal investigator
Cardiovascular Institute and Fuwai Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rhNRG-1 in people with Chronic Heart Failure, run by Zensun Sci. & Tech. Co., Ltd. at 4 sites 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 6 inclusion and 21 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: stopped early, as of the sponsor's last update on 21 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: The same protocol has been launched in United States.). 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?
cardiac function measured by MRI (time frame: 30 days). 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 21 Dec 2017.