Pulmonary Arterial HypertensionPhase 1/2NCT04528056
Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension
A Phase 1/2 study testing Sulfasalazine and Ambrisentan in people with Pulmonary Arterial Hypertension, run by RenJi Hospital at 1 site in China.
Trial summary
Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Sulfasalazine and Ambrisentan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 31 Oct 2022
- Phase
- Phase 1/2
- 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
- Pulmonary artery systolic pressure estimated in the most recent echocardiography examination before screening ≧40mmHg.
- Before the study, subjects received the best traditional pulmonary arterial hypertension(PAH) treatment (such as oral Ca2+ antagonists, oxygen therapy, digoxin, diuretics, and anticoagulants), and no increase, discontinuation, or dose change at least one month before randomization. But it is allowed to stop or adjust anticoagulants, and adjust the therapeutic dose of diuretics.
- The results of echocardiography showed that the systolic and diastolic functions of the left ventricle were normal, and there was no clinically significant left heart disease (such as mitral valve disease).
Who cannot join
- Patients who have received endothelin receptor antagonists and anti-inflammatory drugs within 30 days before randomization.
- Patients with changes in the basic PAH treatment within one month before randomization (such as addition/removal of therapeutic drugs or dose adjustment; including but not limited to oxygen, diuretics, digoxin, anticoagulants, immunosuppressants, or Ca2+ antagonists ). But we allows the discontinuation of anticoagulants or change the dose and the change of diuretic dose.
- Patients who diagnosed with other etiology of PAH, such as portal hypertension, pulmonary vein occlusive disease, etc.
- Patients who have a history of left heart disease including ischemic heart disease, myocardial infarction, symptomatic coronary artery disease; or trans-channel radionuclide angiography, angiography, or echocardiography as assessed by mean pulmonary capillary wedge pressure (or left ventricular end diastolic volume) ≥ 15 mmHg or left ventricular ejection fraction ≤ 40%; or systemic hypertension that cannot be effectively controlled, systolic blood pressure> 160 mmHg or diastolic blood pressure> 100 mmHg.
- Patients who have a history of lung diseases, including chronic obstructive pulmonary disease, interstitial lung disease, etc.
- Patients who have a history of blood diseases, including a history of coagulation disorders within 6 months before screening.
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- Patients who are allergic to two or more drugs or food; or are known to be allergic to one anti-inflammatory drug (steroidal or non-steroidal anti-inflammatory drug).
- Liver function test exceeds or equals 3 times the upper limit of normal or suffering from known Child-Pugh Class C liver disease.
- Patients with chronic renal insufficiency, and the screening creatinine value is greater than 2.5mg/dL (221μmol/L) or need dialysis.
- Patients with other diseases or conditions that can affect the results of the research.
- Patients who participated in other study drugs or medical devices within 30 days before screening.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, 200127
Jian Wang, postgraduate, +8613780172992, wangjian_ky@163.com
About this study
Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.
Read the detailed description
Pulmonary arterial hypertension is characterized by decompensated increase of pulmonary artery pressure owing to continuous progression of pulmonary vascular resistance and can ultimately cause right heart failure even death. At present, the treatment of pulmonary arterial hypertension is mainly the application of specific drug therapy. Specific drug therapy involves the three major pathways of endothelin, nitric oxide and prostacyclin. The main mechanisms of vasodilation and anti-proliferation are used to treat pulmonary arterial hypertension. However, the price of specific drug therapy is too expensive, which puts huge financial pressure on patients. Evidence shows that inflammation exists in the early stages of pulmonary arterial hypertension and anti-inflammatory treatment is effective in animal experiments. Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Sulfasalazine, Ambrisentan, Sulfasalazine's placebo, Ambrisentan's placebo
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfasalazineDrug
Sulfasalazine is an anti-inflammatory and immunosuppressive drug
AmbrisentanDrug
Ambrisentan is one of the specific drug therapy for pulmonary arterial hypertension
Sulfasalazine's placeboDrug
Sulfasalazine's placebo is similar to Sulfasalazine in form and dosage
Ambrisentan's placeboDrug
Ambrisentan's placebo is similar to Ambrisentan in form and dosage
| Study group | Role | What they receive |
|---|---|---|
| Ambrisentan+Sulfasalazine | Experimental | Not described Receives: Drug: Sulfasalazine; Drug: Ambrisentan |
| Ambrisentan+Sulfasalazine's placebo | Active comparator | Not described Receives: Drug: Ambrisentan; Drug: Sulfasalazine's placebo |
| Ambrisentan's placebo+Sulfasalazine | Experimental | Not described Receives: Drug: Sulfasalazine; Drug: Ambrisentan's placebo |
| Ambrisentan's placebo+Sulfasalazine's placebo | Placebo comparator | Not described Receives: Drug: Sulfasalazine's placebo; Drug: Ambrisentan's placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Confirmed Clinical Adverse Event up to the End of Treatment
Clinical adverse event was defined as death.
Measured: Up to end of treatment (data presented up to month 6)
Secondary outcomes (4)
Change From Baseline to Month 6 in 6-minute Walk Distance
The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.
Measured: Baseline to month 6
Change From Baseline to Month 6 in Inflammation Factor
Compose of Interleukin-6
Measured: Baseline to month 6
Change From Baseline to Month 6 in Echocardiography Examination
Assessment of pulmonary artery systolic pressure by echocardiography
Measured: Baseline to month 6
Change From Baseline to Month 6 in Cardiac Function
Compose of B-type natriuretic peptide
Measured: Baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jieyan Shen, PhD, Study chair, Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528056
- Sponsor's protocol ID
- treatment of PAH
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04528056
- Acronym / sponsor ID
- treatment of PAH
- Conditions
- Pulmonary Arterial Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 27 Aug 2020 (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.
Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.
Detailed description
Pulmonary arterial hypertension is characterized by decompensated increase of pulmonary artery pressure owing to continuous progression of pulmonary vascular resistance and can ultimately cause right heart failure even death. At present, the treatment of pulmonary arterial hypertension is mainly the application of specific drug therapy. Specific drug therapy involves the three major pathways of endothelin, nitric oxide and prostacyclin. The main mechanisms of vasodilation and anti-proliferation are used to treat pulmonary arterial hypertension. However, the price of specific drug therapy is too expensive, which puts huge financial pressure on patients. Evidence shows that inflammation exists in the early stages of pulmonary arterial hypertension and anti-inflammatory treatment is effective in animal experiments. Under placebo control, the investigators intend to evaluate the effectiveness and safety of anti-inflammatory therapy and/or targeted drug therapy for early treatment of patients with pulmonary arterial hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ambrisentan+Sulfasalazine | Experimental | Drug: Sulfasalazine, Drug: Ambrisentan |
| Ambrisentan+Sulfasalazine's placebo | Active comparator | Drug: Ambrisentan, Drug: Sulfasalazine's placebo |
| Ambrisentan's placebo+Sulfasalazine | Experimental | Drug: Sulfasalazine, Drug: Ambrisentan's placebo |
| Ambrisentan's placebo+Sulfasalazine's placebo | Placebo comparator | Drug: Sulfasalazine's placebo, Drug: Ambrisentan's placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pulmonary artery systolic pressure estimated in the most recent echocardiography examination before screening ≧40mmHg.
- Before the study, subjects received the best traditional pulmonary arterial hypertension(PAH) treatment (such as oral Ca2+ antagonists, oxygen therapy, digoxin, diuretics, and anticoagulants), and no increase, discontinuation, or dose change at least one month before randomization. But it is allowed to stop or adjust anticoagulants, and adjust the therapeutic dose of diuretics.
- The results of echocardiography showed that the systolic and diastolic functions of the left ventricle were normal, and there was no clinically significant left heart disease (such as mitral valve disease).
Key exclusion criteria (11 listed)
- Patients who have received endothelin receptor antagonists and anti-inflammatory drugs within 30 days before randomization.
- Patients with changes in the basic PAH treatment within one month before randomization (such as addition/removal of therapeutic drugs or dose adjustment; including but not limited to oxygen, diuretics, digoxin, anticoagulants, immunosuppressants, or Ca2+ antagonists ). But we allows the discontinuation of anticoagulants or change the dose and the change of diuretic dose.
- Patients who diagnosed with other etiology of PAH, such as portal hypertension, pulmonary vein occlusive disease, etc.
- Patients who have a history of left heart disease including ischemic heart disease, myocardial infarction, symptomatic coronary artery disease; or trans-channel radionuclide angiography, angiography, or echocardiography as assessed by mean pulmonary capillary wedge pressure (or left ventricular end diastolic volume) ≥ 15 mmHg or left ventricular ejection fraction ≤ 40%; or systemic hypertension that cannot be effectively controlled, systolic blood pressure> 160 mmHg or diastolic blood pressure> 100 mmHg.
- Patients who have a history of lung diseases, including chronic obstructive pulmonary disease, interstitial lung disease, etc.
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 |
|---|---|---|
| SulfasalazineSulfasalazine is an anti-inflammatory and immunosuppressive drug | Drug | Ambrisentan's placebo+Sulfasalazine, Ambrisentan+Sulfasalazine |
| AmbrisentanAmbrisentan is one of the specific drug therapy for pulmonary arterial hypertension | Drug | Ambrisentan+Sulfasalazine, Ambrisentan+Sulfasalazine's placebo |
| Sulfasalazine's placeboSulfasalazine's placebo is similar to Sulfasalazine in form and dosage | Drug | Ambrisentan's placebo+Sulfasalazine's placebo, Ambrisentan+Sulfasalazine's placebo |
| Ambrisentan's placeboAmbrisentan's placebo is similar to Ambrisentan in form and dosage | Drug | Ambrisentan's placebo+Sulfasalazine, Ambrisentan's placebo+Sulfasalazine's placebo |
Primary outcome
Time to First Confirmed Clinical Adverse Event up to the End of Treatment
Time frame: Up to end of treatment (data presented up to month 6)
Clinical adverse event was defined as death.
4 secondary outcomes
Change From Baseline to Month 6 in 6-minute Walk Distance
Time frame: Baseline to month 6
Change From Baseline to Month 6 in Inflammation Factor
Time frame: Baseline to month 6
Change From Baseline to Month 6 in Echocardiography Examination
Time frame: Baseline to month 6
Change From Baseline to Month 6 in Cardiac Function
Time frame: Baseline to month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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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.
Jieyan Shen, PhD study chair
Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Sulfasalazine and Ambrisentan in people with Pulmonary Arterial Hypertension, run by RenJi Hospital 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 3 inclusion and 11 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 27 Aug 2020. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Jieyan Shen, PhD (+8613701864819, shenjieyan@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Confirmed Clinical Adverse Event up to the End of Treatment (time frame: Up to end of treatment (data presented up to month 6)). 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 27 Aug 2020.