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Table 1 Summary of the clinical trials that used pirfenidone for fibrosis-related diseases

From: The multifaceted role of pirfenidone and its novel targets

Disease Dose and time Type of study Number of patient Effects Reference
Interstitial pulmonary fibrosis 3600 mg/daily for 2 years Open-label study 54 Increase in 1 and 2 year survival. Stabilized lung function. [42]
Interstitial pulmonary fibrosis 600 mg three times daily for 12 months Double-blind, randomized, placebo- controlled trial 107 Improvement in SpO2 during a 6-minute exercise test. No episodes of acute exacerbation of IPF in PFD group. [43]
Hermansky-Pudlak syndrome 800 mg three times daily for 44 months Randomized, placebo-controlled trial 11 Loss of pulmonary functions occurred at a slower rate. [44]
HCV related liver disease 1200 mg/daily for 12 months Open-label pilot study 15 30% of patients had less fibrosis after treatment. Downregulation of Col I, TGFβ and TIMP-1. Improvement in quality of life (SF-36 test). [55]
Focal segmental glomerulosclerosis 800 mg three times daily for 5 to 37 months Open-label pilot study 18 Slowed renal function decline; improvement of 25% [67]
Hypertropic scars PFD 8% gel for 6 months Open-label pilot study 33 Improvement in the Vancouver scar score in 66.6% of patients. [70]
  1. HCV = hepatitis C virus; PFD = pirfenidone; SF = Short Form; SpO2 = lowest oxygen saturation by pulse oximetry; TGF = transforming growth factor; TIMP = tissue inhibitor of metalloproteinase.