Status:
COMPLETED
Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension
Lead Sponsor:
Vigonvita Life Sciences
Collaborating Sponsors:
Shanghai Institute of Materia Medica, Chinese Academy of Sciences
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is a phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute haemodynamic parameters in patients with pulmonary arterial hypertension.The trial is ex...
Detailed Description
This study is a multi-center, randomized, placebo and positive controlled phase IIa proof-of-concept study to evaluate the effect of single-dose TPN171H tablets on acute hemodynamic parameters in pati...
Eligibility Criteria
Inclusion
- Patients aged 18 to 75;
- Patients who have voluntarily decided to participate in this study, and signed the informed consent form;
- Patients who are able to understand and follow study plans and instructions;
- Patients with symtomatic PAH (Group1), a pulmonary vascular resistance (PVR) \> 3 Wood, a mean pulmonary artery pressure (mPVP) ≥25 mmHg and a pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg either due to:
- Idiopathic PAH (IPAH)
- Familial PAH
- Associated PAH due to drugs or toxins
- Associated PAH due to connective tissue disease
- Associated PAH due to congenital heart disease, if patients underwent surgical correction more than 1 year prior to screening
- Have a current diagnosis of being in WHO functional class II or III;
- Patients who are willing to take proper contraceptive during the study and within 3 months after the study completed.
Exclusion
- All types of PH except subtypes of Group1 specified in the inclusion criteria;
- Moderate to severe COPD (FEV1 \< 60% predicted);
- Moderate to severe restrictive lung disease (FVC \< 70% predicted);
- Pre-treatment with PAH therapy within the last 1 months before the screening visit (including endothelin receptor antagonists, PDE5 inhibitors, guanylate cyclase agonist and prostacycline analogues);
- A "positive" response to acute vasodilator testing;
- Coagulation dysfunction (defined as activated partial thromboplastin time and international normalized ratio are both \>1.5 times upper limit normal) or patients with potential bleeding risk;
- Hepatic dysfunction indicated by: serum bilirubin\>3 times upper limit normal, ALT and AST\>2.5 times upper limit normal;
- Renal insufficiency (creatinine clearance\<30 mL/min)；
- Systolic blood pressure\<90 mmHg at screening;
- QT prolongation at screening, whose values (QTcF) exceeding 450 msec in males and 470 msec in females;
- Have enrolled in/or have a plan of an exercise training program for pulmonary rehabilitation before the screening visit/or during the study;
- Patients who have a recent (within 3 months) history of abusing alcohol or illicit drugs;
- Body weight\<40 kg；
- Patients who have participated in a clinical study involving another investigational drug within 1 month before the screening visit;
- For any other reasons that affect compliance with the study protocol, especially the long-term monitoring of floating catheters, according to the decision of investigators;
- HBV, HCV, HIV or Tp infection;
- Patients with gastrointestinal, urinary, reproductive, immunologic, endocrine, or central nervous system disease that, in the opinion of the investigator, will affect the study;
- Have a history of malignancies within 2 years, except for a cured basal cell or skin squamous cell carcinoma;
- Pregnant women, or breast feeding women;
- Patients with hypersensitivity to iloprost or any of the excipients.
Key Trial Info
Start Date :
November 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04483115
Start Date
November 16 2020
End Date
June 29 2022
Last Update
December 24 2024
Active Locations (9)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
3
Fuwai Hospital CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016