Pirfenidone and Advanced Liver Fibrosis. (PROMETEO)
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|ClinicalTrials.gov Identifier: NCT04099407|
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Pirfenidone (PFD), an oral antifibrotic drug with anti-inflammatory and anti-oxidant properties, has been granted marketing authorization by the European Medicine Agency and FDA, for the treatment of idiopathic pulmonary fibrosis (IPF). However, few studies have focused on its clinical utilization in patients with advanced hepatic fibrosis. Therefore, Investigators aim to evaluate a prolonged-release PFD formulation (PR-PFD) plus standard of care management on disease progression in patients with advanced liver fibrosis (ALF).
Methods: Patients with diverse chronic liver disease etiology (alcohol-related, hepatitis B or C, autoimmune or fatty liver disease) will be screened with two non invasive liver fibrosis methods (Fibroscan®) and Fibro Test®) and those with ALF (F3 or F4) will be treated for at least 12 months with PR-PFD. Antifibrotic effects Will be assessed at 6 and 12 months; variations greater than 30% in estimated fibrosis scores or 1 point on the METAVIR scale will be considered clinically significant. PFD plasma levels, serum endothelin-1, IL6, TNFα and TGFβ1, Quality of life and fatigue scales will be evaluated. Parametric and non parametric statistics will be utilized and p values lower tan 5% will be considered clinically significant.
|Condition or disease||Intervention/treatment||Phase|
|Liver Fibrosis Chronic Liver Disease||Drug: Pirfenidone Other: Standard of care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||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|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Actual Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Antifibrotic plus standard of care treatment
Prolonged release pirfenidone formulation in combination with standard of care treatment.
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.
Other: Standard of care
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.
- Fibrosis reversal based on Fibrotest [ Time Frame: 12 months ]Reduction of fibrosis score by at least 30% in Fibrotest units.
- Fibrosis reversal based on Hepatic Elastography [ Time Frame: 12 months ]Reduction of fibrosis score by at least 30% in kilo Pascals (kPa) according to accurate hepatic elastography measurements.
- Fibrosis reversal based on METAVIR [ Time Frame: 12 months ]Reduction of fibrosis score by at least one point on the METAVIR fibrosis scale.
- Safety endpoint based on clinical side effects [ Time Frame: 12 months ]Clinical side effects wiil be evaluated according to World Health Organization grade modified toxicity scale.
- Improvement in Quality of life [ Time Frame: 12 months ]Quality of life will be evaluated according to nonutility-based Short Form-36 survey.
- Improvement in Liver function values: bilirubin [ Time Frame: 12 months ]Improvement by at least 30% in serum Bilirubin levels (mg/dL)
- Improvement in Liver function values:albumin [ Time Frame: 12 months ]Improvement by at least 30% in serum albumin levels (mg/dL)
- Improvement in fibrosis molecular marker [ Time Frame: 12 months ]Improvement in serum concentrations of transforming growth factor beta (TGF-β1), quantified by ELISA in an automated enzyme-linked immunosorbent assay (EIA) analyzer.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099407
|Contact: Jorge L Poo, MDemail@example.com|
|Contact: Javier Lizardi, MDfirstname.lastname@example.org|