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

Patients assigned to this arm will continue their nucleos(t) analogue

Patients assigned to this arm will continue their existing nucleos(t)ide therapy and also be assigned peg-interferon alpha 2b 1.5mcg/kg sc weekly

Patients assigned to this arm will stop their existing nucleos(t)ide therapy after one month overlap after starting peg-interferon alpha 2b 1.5mcg/kg sc weekly

Chronic Hepatitis B

peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly

Nucleos(t)ide analogue therapy

Changi General Hospital

National University Hospital

Singapore General Hospital

Tan Tock Seng Hospital

Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy

SWITCH OR ADD PEGYLATED-INTERFERON IN CHRONIC HEPATITIS B PATIENTS ON LONG TERM NUCLEOS(T)IDE THERAPY (SWAP TRIAL)

Seng Gee Lim

Director of Hepatology, Dept of Gastroenterology and Hepatology

Singapore Clinical Research Institute

Merck Sharp & Dohme Corp.

Three arm parallel study randomised 1:2:2

Kidney Disease

Hypoxyprobe-1 is a biological marker used to detect oxygen levels in tissue;subjects will receive and intravenous solution for 20 minutes containing 500mg/m^2 two-three hours prior to their standard of care biopsy

Hypoxyprobe-1

Wisconsin Institute for Medical Research (WIMR)

University of Wisconsin Hospital and Clinics

Role of Nox2 in CNI-induced Renal Fibrosis

The Role of Nox2 in CNI-Induced Renal Fibrosis

The Nox2 protein will be determined in subjects who are potentially have CNI nephrotoxicity

12 months after a baseline BOLDMRI, subjects will have a second BOLD MRI in order to determine whether there is increased oxygenation

University of Wisconsin, Madison

The group who receive spironolactone, the dose employed will be 25 mg each other day and titrated to 25 mg daily according to potassium.

Renal Failure

Spironolactone

Hospital of the Medical School of Botucatu

Effects of Spironolactone in Dialysis

Assessment of the Effects of the Combination of Spironolactone to Conventional Pharmacotherapy in Dialysis Patients

The reduction of left ventricular hypertrophy will be measured by echocardiography, blood pressure monitoring residential and pulse wave velocity.

Measurement of serum potassium and other routine laboratory parameters pertaining to the hemodialysis unit of the Hospital of the Medical School of Botucatu - UNESP.

pulmonary fibrosis/phosphatase

Pirfenidone and Advanced Liver Fibrosis.

Efficacy of Switching or Adding Pegylated Interferon in Chronic Hepatitis B Patients on Long Term Oral Antiviral Therapy

Role of Nox2 in CNI-induced Renal Fibrosis

Effects of Spironolactone in Dialysis

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