NCT02112799

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2014

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
16 days until next milestone

Study Start

First participant enrolled

April 30, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2016

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

2.1 years

First QC Date

April 9, 2014

Last Update Submit

October 16, 2017

Conditions

Chronic Hepatitis B

Keywords

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • To assess the dose-related safety and tolerability of NVR 3-778 in healthy volunteers and hepatitis B patients

    Up to 28 days

Study Arms (4)

NVR 3-778

EXPERIMENTAL

NVR 3-778 in varying doses of capsules by mouth for 1 day, 14 days, or 28 days

Drug: NVR 3-778

Placebo for NVR 3-778

PLACEBO COMPARATOR

Placebo for NVR 3-778 in varying doses of capsules by mouth for 1 day, 14 days, or 28 days

Drug: Placebo for NVR 3-778

NVR 3-778 and Pegasys

EXPERIMENTAL

NVR 3-778 and Pegasys in combination in a yet to be determined dose by mouth and subcutaneous injection for 28 days

Drug: NVR 3-778Drug: Pegasys

Pegasys

ACTIVE COMPARATOR

Pegasys alone in a yet to be determined dose by subcutaneous injection for 28 days

Drug: Pegasys

Interventions

NVR 3-778DRUG
NVR 3-778NVR 3-778 and Pegasys
Placebo for NVR 3-778DRUG

Sugar pill manufactured to mimic the NVR 3-778 capsule

Placebo for NVR 3-778
PegasysDRUG
Also known as: peginterferon alfa-2a
NVR 3-778 and PegasysPegasys

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Healthy volunteers may be male or female between 18 and 65 years old with a BMI of 18-32kg/m2. They must be in good health not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study. Patients enrolling in Part II of the study, may be male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2. Patients must have HBeAg positive, chronic hepatitis B with no history of clinical decompensation, and must not have been treated for hepatitis B before.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Hamilton, Waikato Region, New Zealand

Location

Unknown Facility

Auckland, New Zealand

Location

Related Publications (1)

  • Yuen MF, Gane EJ, Kim DJ, Weilert F, Yuen Chan HL, Lalezari J, Hwang SG, Nguyen T, Flores O, Hartman G, Liaw S, Lenz O, Kakuda TN, Talloen W, Schwabe C, Klumpp K, Brown N. Antiviral Activity, Safety, and Pharmacokinetics of Capsid Assembly Modulator NVR 3-778 in Patients with Chronic HBV Infection. Gastroenterology. 2019 Apr;156(5):1392-1403.e7. doi: 10.1053/j.gastro.2018.12.023. Epub 2019 Jan 6.

    PMID: 30625297DERIVED

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

NVR 3-778peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2014

First Posted

April 14, 2014

Study Start

April 30, 2014

Primary Completion

May 18, 2016

Study Completion

May 18, 2016

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

NZ(2)