Prolonged release pirfenidone formulation in combination with standard of care treatment.

Liver Fibrosis

Chronic Liver Disease

Treatment consist of 600 mg tablets of a prolonged-released formulation of Pirfenidone. Patients are instructed to take medication orally, every 12 h, after breakfast and dinner.

Pirfenidone

All participants will require to adhere to a standard of care including nutritional support, quarterly medical evaluation to review lab results and adjust medications, bi-annual Fibrotest, FibroScan and liver ultrasound, and annual upper-gastrointestinal endoscopy.

Standard of care

Liver Clinic 1

Pirfenidone and Advanced Liver Fibrosis.

Pirfenidone in Combination With Standard of Care Treatment in Patients With Advanced Liver Fibrosis. Multicenter, Open Trial Focused on Safety, Fibrosis Efficacy Evaluation, and Pharmacokinetic Data.

Reduction of fibrosis score by at least 30% in Fibrotest units.

Reduction of fibrosis score by at least 30% in kilo Pascals (kPa) according to accurate hepatic elastography measurements.

Reduction of fibrosis score by at least one point on the METAVIR fibrosis scale.

Clinical side effects wiil be evaluated according to World Health Organization grade modified toxicity scale.

Quality of life will be evaluated according to nonutility-based Short Form-36 survey.

Improvement by at least 30% in serum Bilirubin levels (mg/dL)

Improvement by at least 30% in serum albumin levels (mg/dL)

Improvement in serum concentrations of transforming growth factor beta (TGF-β1), quantified by ELISA in an automated enzyme-linked immunosorbent assay (EIA) analyzer.

Jorge L Poo

Principal Investigador, Head of Liver Clinic

Grupo Mexicano para el Estudios de las Enfermedades Hepaticas

This will be a real-life, multicenter, open-label, proof of concept trial to determine the safety and efficacy of 12 months of treatment with PR-PFD in combination with standard of care treatment

The patients were intravenously injected with 68Ga-BMV101 and underwent PET/CT scan 1 h and 2.5 h after that.

Idiopathic Pulmonary Fibrosis

68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.

68Ga-BMV101

Peking Union Medical College Hospital

68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis

Safety and Diagnostic Performance of 68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis

Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of lungs will be measured.

Blood pressure of patients will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.

Pulse will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.

Respiration frequency will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.

Temperature will be measured at three time points for each patients: right before injection, after scanning, and 24 hours after treatment.

Routine blood test of patients will be measured at two time points: right before injection and 24 hours after treatment.

Routine urine test of patients will be measured at two time points: right before injection and 24 hours after treatment.

Serum alanine aminotransferase of patients will be measured at two time points: right before injection and 24 hours after treatment.

Serum albumin of patients will be measured at two time points: right before injection and 24 hours after treatment.

Serum creatinine of patients will be measured at two time points: right before injection and 24 hours after treatment.

Adverse events within 5 days after the injection and scanning of patients and patients will be followed and assessed.

idiopathic pulmonary fibrosis/آلبومین

Pirfenidone and Advanced Liver Fibrosis.

68Ga-BMV101 PET/CT in Patients With Idiopathic Pulmonary Fibrosis

کاملترین پایگاه داده گیاهان دارویی با پشتیبانی علمی