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Presentation
of the trial
A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis

To learn more about this study, you may contact the study research staff:
Mari Carmen DELATTE
mari-carmen.delatte@inventivapharma.com

Exclusion Criteria

  • Cyclophosphamide during the past 3 months
  • Requirement of IV prostanoids for pulmonary hypertension in the last 3 months
  • Renal insufficiency defined by a creatinine clearance of less than 30 ml/min and/or past/current renal crisis
  • Hepatic impairment i.e. primary biliary cirrhosis and unexplained persistent liver function abnormality
  • Gallbladder disease
  • Diabetic ketoacidosis
  • Severe cardiac (LVEF < 45%)* and />or pulmonary disease (FVC < 50%) or pulmonary hypertension proven by right heart catheterisation
  • History of heart failure, symptomatic coronary artery disease, significant ventricular tachyarrhythmia, stent placement, coronary artery bypass surgery, and/or myocardial infarction
  • Recipient of solid organ transplant
  • Gastrointestinal involvement preventing oral administration of study drug
  • Chronic infections, positive serology for infection with hepatitis B or C
  • Pregnancy, Lactation. Woman of childbearing potential unwilling to use a medically acceptable form of birth control
  • History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma of the skin, treated cervical dysplasia, or treated in situ cervical cancer
  • A recent history of alcohol or drug abuse, non-compliance with other medical therapies
  • Participation in a clinical study involving another investigational drug or device within the past 4 weeks or during the study
  • Laboratory parameters at the pre-treatment visit showing any of the following abnormal results: transaminases > 2x the upper limit of normal (ULN) and/or bilirubin > 2x ULN; neutrophil count < 1,500/mm3; platelet count < 100,000/mm3; abnormal haemoglobin
  • Known hypersensitivity or allergy to class of drugs or the investigational product
  • Any condition or treatment, which in the opinion of the investigator, places the subject at unacceptable risk as a patient in the trial
  • Women of childbearing potential therefore need to use an effective contraceptive measure until at least 2 weeks after treatment discontinuation



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