Pilot Study of the Safety and Efficacy of Sulfasalazine in Pulmonary Arterial Hypertension

NCT04528056 | Unknown Phase 1 DMC

• 1 other identifier: treatment of PAH
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

• Time to First Confirmed Clinical Adverse Event up to the End of Treatment

  Clinical adverse event was defined as death.

  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

  Baseline to month 6

• Change From Baseline to Month 6 in Inflammation Factor

  Baseline to month 6

• Change From Baseline to Month 6 in Echocardiography Examination

  Baseline to month 6

• Change From Baseline to Month 6 in Cardiac Function

  Baseline to month 6

Study Arms (4)

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

Interventions

Sulfasalazine DRUG

Sulfasalazine is an anti-inflammatory and immunosuppressive drug

Ambrisentan's placebo+Sulfasalazine; Ambrisentan+Sulfasalazine

Ambrisentan DRUG

Ambrisentan is one of the specific drug therapy for pulmonary arterial hypertension

Ambrisentan+Sulfasalazine; Ambrisentan+Sulfasalazine's placebo

Sulfasalazine's placebo DRUG

Sulfasalazine's placebo is similar to Sulfasalazine in form and dosage

Ambrisentan's placebo+Sulfasalazine's placebo; Ambrisentan+Sulfasalazine's placebo

Ambrisentan's placebo DRUG

Ambrisentan's placebo is similar to Ambrisentan in form and dosage

Ambrisentan's placebo+Sulfasalazine; Ambrisentan's placebo+Sulfasalazine's placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Sulfasalazine; ambrisentan

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Study Officials

• Jieyan Shen, PhD

  Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital

  STUDY CHAIR

Central Study Contacts

Jieyan Shen, PhD

CONTACT

+8613701864819; shenjieyan@renji.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 27, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: October 31, 2022
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

CN (1)