NCT02710604

Brief Summary

This is a phase 2a study to evaluate the safety and tolerability of multiple oral doses of CMX157 at increasing dose levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
Last Updated

September 13, 2017

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

March 14, 2016

Last Update Submit

September 12, 2017

Conditions

Infectious Disease

Keywords

chronic hepatitis B(CHB)

Outcome Measures

Primary Outcomes (2)

  • Evaluation of the safety and tolerability of increasing multiple oral doses of CMX157 in HBV + patients

    Capture adverse events, physical examinations, ECGs and clinical laboratory panels

    28 days

  • To evaluate the antiviral activity of CMX157 versus tenofovir disproxil fumarate(TDF).

    HBV DNA levels

    28 days

Secondary Outcomes (4)

  • Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects, Cmax.

    28 days

  • Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Tmax.

    28 days

  • Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: AUC.

    28 days

  • Evaluation of the pharmacokinetics of multiple doses of oral CMX157 in HBV + subjects: Cmin.

    28 days

Study Arms (5)

CMX157 5mg versus TDF

ACTIVE COMPARATOR

CMX157, 5mg tablet, 28 days versus TDF(tenofovir disoproxil fumerate) 300mg tablet, 28 days

Drug: CMX157Drug: TDF

CMX157 10mg versus TDF

ACTIVE COMPARATOR

CMX157, 10mg tablet, 28 days versus TDF 300mg tablet, 28 days

Drug: CMX157Drug: TDF

CMX157 25mg versus TDF

ACTIVE COMPARATOR

CMX157, 25mg tablet, 28 days versus TDF 300mg tablet, 28 days

Drug: CMX157Drug: TDF

CMX157 50mg versus TDF

ACTIVE COMPARATOR

CMX157, 50mg tablet, 28 days versus TDF 300mg tablet, 28 days

Drug: CMX157Drug: TDF

CMX157 100mg versus TDF

ACTIVE COMPARATOR

CMX157, 100mg tablet, 28 days versus TDF 300mg tablet, 28 days

Drug: CMX157Drug: TDF

Interventions

CMX157DRUG

tablet

Also known as: lipid conjugate TFV(tenofovir)
CMX157 100mg versus TDFCMX157 10mg versus TDFCMX157 25mg versus TDFCMX157 50mg versus TDFCMX157 5mg versus TDF
TDFDRUG

300mg tablet

Also known as: tenofovir disoproxil fumerate
CMX157 100mg versus TDFCMX157 10mg versus TDFCMX157 25mg versus TDFCMX157 50mg versus TDFCMX157 5mg versus TDF

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Capable of giving written informed consent.
  • Capable of completing study requirements.
  • Chronic hepatitis B positive.
  • HBV treatment naïve.

You may not qualify if:

  • Positive result for HCV(hepatitis C virus), HDV(hepatitis D virus) or HIV(human immunodeficiency virus).
  • History or medical condition that could impact patient safety.
  • Current or past abuse of alcohol or illicit drugs.
  • Abnormal laboratory value or ECG.
  • Pregnant or breastfeeding.
  • Clinical, histologic or laboratory evidence of significant liver fibrosis or cirrhosis.
  • Systemic immunosuppression.
  • Received an investigational drug or investigational vaccine within the 90 days prior to the first dose of study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bangkok, Thailand

Location

MeSH Terms

Conditions

Communicable DiseasesHepatitis B, Chronic

Interventions

hexadecyloxypropyl 9-(2-(phosphonomethoxy)propyl)adenine

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis BBlood-Borne InfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic Disease

Study Officials

  • John Sullivan-Boylai, MD

    ContraVir Pharmaceuticals, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

May 1, 2016

Primary Completion

July 18, 2017

Study Completion

July 18, 2017

Last Updated

September 13, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will share

Locations

TH(1)