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A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis

NCT04255069 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-02-13

No results posted yet for this study

Summary

A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis

Conditions

  • Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Interventions

DRUG

Placebo

A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily

DRUG

Dose 1 JKB-122

A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily

DRUG

Dose 2 JKB-122

A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily

Sponsors & Collaborators

  • TaiwanJ Pharmaceuticals Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2023-06-30
Completion
2023-12-31
FDA Drug
Yes

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Entities

Drugs

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 NCT04255069 on ClinicalTrials.gov