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Prolonged Release Pirfenidone Versus Placebo in Compensated Cirrhosis.

NCT06267794 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2024-02-20

No results posted yet for this study

Summary

This will be a multicenter, double-blind clinical trial to evaluate the safety and efficacy of two doses of prolonged release pirfenidone, compared against placebo plus conventional therapy in patients with compensated liver cirrhosis. The study will be conducted in compliance with International Standard good clinical practices (GCPs) and the Declaration of Helsinki. The protocol is approved by a local Institutional Review Board and registered in clinical trials.gov.

Conditions

Interventions

DRUG

Pirfenidone 1200 mg

1200 mg dosage. Additionally, all participating subjects will receive standard treatment care for patients with cirrhosis.

DRUG

Pirfenidone 1800 mg

1800 mg dosage. Additionally, all participating subjects will receive standard treatment care for patients with cirrhosis.

DRUG

Placebo

0 mg dosage. Additionally, all participating subjects will receive standard treatment care for patients with cirrhosis.

Sponsors & Collaborators

  • Jorge L Poo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-26
Primary Completion
2021-12-30
Completion
2023-03-24

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06267794 on ClinicalTrials.gov