Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-16

Study Completion Date

2022-06-29

Brief Summary

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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 expected to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil tablets 20mg, 40mg group, each group 10 cases.

Detailed Description

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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 patients with pulmonary arterial hypertension.The trial is expected to include 60 patients, divided into 6 groups, according to 1:1:1:1:1:1 into the placebo group and the test drugs 2.5mg, 5mg, 10mg group, tadalafil tablets 20mg, 40mg group, each group 10 cases. During the screening period, the tube placement period, and the observation period, the patients will conduct various inspections and evaluation observations as required.

The Swan-Ganz floating catheter and echocardiography were used to evaluate the efficacy of TPN171H; PK parameters: including Tmax, Cmax, AUC0-t , t1/2,CL/F, Vz/F, λz; Safety evaluation indicators include: vital signs, physical examination, laboratory examination (blood routine, blood biochemistry, blood gas analysis), 12-lead ECG, adverse events.

Conditions

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Pulmonary Arterial Hypertension

Keywords

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pulmonary arterial hypertension Acute Haemodynamic Study PK/PD study TPN171H Simmerafil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

Tablets; Oral; Single dose

Interventions

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TPN171H

Tablets; Oral; Single dose

Intervention Type DRUG

Placebo

Tablets; Oral; Single dose

Intervention Type DRUG

Tadalafil

Tablets; Oral; Single dose

Intervention Type DRUG

Other Intervention Names

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Simmerafil ADCIRCA

Eligibility Criteria

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Inclusion Criteria

* 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:

1. Idiopathic PAH (IPAH)
2. Familial PAH
3. Associated PAH due to drugs or toxins
4. Associated PAH due to connective tissue disease
5. 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yong Huo

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

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China

Other Identifiers

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TPN171H-P201

Identifier Type: -

Identifier Source: org_study_id

Acute Haemodynamic Study of TPN171H in Patients with Pulmonary Arterial Hypertension

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

TPN171H 2.5mg group

TPN171H

TPN171H 5mg group

TPN171H

TPN171H 10mg group

TPN171H

Placebo group

Placebo

tadalafil 20mg group

Tadalafil

tadalafil 40mg group

Tadalafil

Interventions

TPN171H

Placebo

Tadalafil

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Sponsors

Shanghai Institute of Materia Medica, Chinese Academy of Sciences

Vigonvita Life Sciences

Responsible Party

Principal Investigators

Yong Huo

Locations

Peking Union Medical College Hospital

Peking University First Hospital

Fuwai Hospital CAMS&PUMC

The First Affiliated Hospital of Chongqing Medical University

Gansu Provincial Hospital

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

The Second Xiangya Hospital of Central South University

First Affiliated Hospital Of Gannan Medical University

Shanghai Pulmonary Hospital

Countries

Other Identifiers

TPN171H-P201