Clinical trials

PHRG The Research Clinical trials

Clinical trials constitute the last stage of research, before the marketing of new therapeutic molecules. A rigorous selection process is carried out to choose a promising molecule for the prevention, treatment or diagnosis of a disease, while minimizing the risks of adverse effects.

Potentially therapeutic molecules must be approved by government authorities before being administered to a volunteer. Depending on the nature of the study, the new molecule can be administered to a healthy volunteer or to a sick patient who is not responding well to current treatments.

Research carried out within the pulmonary hypertension research group has led to the discovery of several promising molecules. Consult your doctor to verify your eligibility for one of our studies in pulmonary hypertension or pulmonary fibrosis.

Clinical trials within the group are divided into two main areas: pulmonary hypertension and fibrosis.

Ongoing trials
  • Étude BRD4
    A Randomized, multicentric  phase 2 study of BRDs inhibitor, Apabetalone vs Placebo, in Subjects with Pulmonary Arterial Hypertension (NCT03655704).
  • Étude PARP1
    A Randomized, multicentric  phase I study of PARP1 inhibitor, Olaparib, in Subjects with Pulmonary Arterial Hypertension (NCT03251872).
  • The influence of respiratory system compliance on pulmonary artery pressures in obese patients with pulmonary hypertension
    Accurate measurements of pulmonary vascular pressures are essential to the appropriate diagnosis, patient’s characterization and treatment of pulmonary hypertension. Pulmonary artery pressure could be influenced by subject’s weight and pulmonary function. In this project, we want to compare pressure on pulmonary vascular pressures on 3 groups: subjects with a body mass index between 18.5 to 24.9kg/m2, between 25.0 to 29.9 kg/m2 and more than 30.0 kg/m2.
  • Biobank
    This project consists to take tissues from a pulmonary transplantation or following a death. These tissues are used to study oncoproteins and  microRNAs know to be altered in Pulmonary Hypertension.
  • SELECT
    This international, phase 3, randomized, multicenter study evaluates the efficacy and safety of selexipag (a selective IP receptor agonist) versus placebo in patients with chronic postembolic pulmonary hypertension inoperable or persistent after surgery. Patients with or without basic treatment are eligible.
  • ADVANCE
    This international, multicenter, randomized phase 3 study evaluates the efficacy and safety of ranelipag (a selective IP receptor agonist) versus placebo in patients already treated for pulmonary arterial hypertension (PAH).
  • New biomarkers predicting severity, prognosis and response to interventions in diverse types of pulmonary hypertension characterized by pulmonary vascular remodeling
    Several types of pulmonary hypertension (PH) are characterized by pulmonary vascular remodeling (PVR). The prototype of PVR is pulmonary arterial hypertension (PAH), a disease characterized by progressively increased pulmonary vascular resistance ultimately leading to right ventricular (RV) failure and death. PAH may be idiopathic or associated with various conditions and predominantly affects young adults. The prevalence of PAH is estimated at 60 persons per million. Despite newly developed therapies, most patients display persistent exercise intolerance and long-term prognosis remains poor. Limited tools are available to predict long-term outcomes in PAH. More importantly, no biomarkers are predictive of subsequent response to therapy. Referral for life-saving interventions such as lung transplantation is thus uselessly delayed for the significant proportion of patients that are unresponsive to new therapies. PH is also a common complication of cardiovascular diseases, and especially valvular heart diseases (VHD). PH-VHD may be completely reversible upon surgical valve replacement or repair. However, in a subset of patients with long standing PH-VHD, PH is irreversible despite surgery because of progressive PVR. Moreover, postoperative PH-VHD markedly increases the clinical burden of VHD and is a strong predictor of mortality. The complex interaction between the VHD severity, level of PH and other comorbidities, makes the PVR gravity (thus the hemodynamic outcome following surgery) difficult to predict preoperatively. In both conditions, a biomarker directly linked to the PVR process and predicting disease severity and outcomes is thus tragically lacking. The general objective of this proposal is to systematically validate new biomarkers in patients suffering from PAH and PH-VHD.
  • Skeletal muscle mitochondrial abnormalities and the metabolic syndrome in pulmonary arterial hypertension
    Many evidences indicate that exercice limitation in PAH is not simply due to pulmonary hemodynamic impairment, but that other determinants are involved. Interestingly, even in absence of obesity or diabetes, insulin resistance and metabolic syndrome are highly prevalent amongst PAH patients and associated with worse outcomes. Our research group is dedicated to understand the mechanisms of metabolic syndrome development in PAH. Specifically, we aim to compare syndrome development on PAH patients to non PAH patients.

Completed trials
  • REPO
    A Randomized, monocentric study of First-Line Revatio in Subjects with Portopulmonary Hypertension.
  • TRITON
    A Randomized, multicentric Study of First-Line Selexipax, Macitentan and Tadalafil Combination Therapy versus Macitentan and Tadalafil combination therapy of subjects with Pulmonary Arterial Hypertension
  • CATALYST
    Monocentric Study of Bardoxolon therapy in patients with pulmonary arterial hypertension (PAH) associated with connective tissue disease.
  • Étude Roche FPI-HTP (MA29957)
    Study of Sildenafil therapy in patients with idiopathic pulmonary fibrosis with probability of pulmonary hypertension (mPAP › 20mmHg or sPAP 34 mmHg +CVP).

Ongoing trials
  • Biobanque
    This project consists to take tissues from a pulmonary transplantation, an open biopsy or following a death.
  • ISABELLA 2
    This international, multicentre, randomized phase 3 study evaluates the efficacy and safety of GLPG 1690 (an autotaxin inhibitor) versus placebo in patients with idiopathic pulmonary fibrosis.

Completed trials
  • HOPE-IPF
    This study consists to perform measurement of pulmonary function on diagnostic idiopathic pulmonary fibrosis patients without biopsy. They receive Nintedanib medication.
  • MII unclassifiable (study MA39189)
    This  is a multicenter, international, randomized phase II trial of Pirferidone in patients with unclassifiable progressive fibrosing interstitial lung disease.
  • Roche FPI-HTP
    This  is a randomized study of Sildenafil therapy in patients with advanced idiopathic pulmonary fibrosis with high probability of pulmonary hypertension (mPAP› 20mmHg on catheterism or sPAP 34mmHg + CVP on echo).