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Safety and Efficacy Study of NVR 3-778 in Healthy Volunteers and Hepatitis B Patients

NCT02112799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-10-18

No results posted yet for this study

Summary

This Phase 1 trial will assess the dose-related safety and PK profile of different doses of NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.

Conditions

Interventions

DRUG

NVR 3-778

DRUG

Placebo for NVR 3-778

Sugar pill manufactured to mimic the NVR 3-778 capsule

DRUG

Pegasys

Sponsors & Collaborators

  • Novira Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-05-18
Completion
2016-05-18
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

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 NCT02112799 on ClinicalTrials.gov