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Phase 1b/2, Open Label, Repeat Dose, Dose Escalation Study of ND-L02-s0201 Injection in Subjects With Moderate to Extensive Fibrosis (METAVIR F3-4)

NCT02227459 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-05-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of multiple doses of ND-L02-s0201 in subjects with moderate to extensive hepatic fibrosis.

Conditions

  • Moderate to Extensive Hepatic Fibrosis (METAVIR F3-4)

Interventions

DRUG

ND-L02-s0201 Injection

Sponsors & Collaborators

Principal Investigators

  • Eric Lawitz, MD · Texas Liver Institute

  • Rozalina Balabanska, MD · Tokuda Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • United States
  • Bulgaria

Study Locations

More Related Trials

Entities

Companies

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 NCT02227459 on ClinicalTrials.gov