NCT01217632

Brief Summary

The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who are eligible for antiviral therapy.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_2

Geographic Reach
2 countries

9 active sites

Status
terminated

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

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

4.8 years

First QC Date

September 30, 2010

Last Update Submit

August 12, 2016

Conditions

Liver Fibrosis Due to Chronic Hepatitis B Infection

Keywords

Connective tissue growth factor (CTGF)human IgG1 monoclonal antibody

Outcome Measures

Primary Outcomes (1)

  • To determine the efficacy of FG-3019 administered every 3 weeks for 45 weeks on liver fibrosis in subjects with chronic active hepatitis B infection on entecavir therapy

    every 3 weeks for 45 weeks

Secondary Outcomes (1)

  • To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population

    every 3 weeks for 45 weeks

Study Arms (2)

FG-3019 Placebo

PLACEBO COMPARATOR

Placebo will be administered at 15-45 mg/kg every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.

Drug: PlaceboDrug: Entecavir

FG-3019

EXPERIMENTAL

FG-3019 at a dose of 15-45 mg/kg will be administered every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.

Drug: FG-3019Drug: Entecavir

Interventions

FG-3019DRUG

FG-3019 at a dose of 15-45 mg/kg will be administered every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.

FG-3019
PlaceboDRUG

Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.

FG-3019 Placebo
EntecavirDRUG
Also known as: Entecavir Dispersible (generic)
FG-3019FG-3019 Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Age of 18 to 75 years, inclusive
  • HBsAg positive for ≥24 weeks prior to screening
  • Liver fibrosis, confirmed by biopsy and histology
  • Willing to use contraception

You may not qualify if:

  • Female subjects who are pregnant or nursing
  • Prior antiviral therapy, with the exception of interferon therapy \>6 months prior to Day 1
  • Severe heart failure
  • Present hepatocellular carcinoma and history of other cancers
  • Severe anemia
  • Advanced kidney disease
  • Immunosuppressive therapy within 24 weeks prior to screening
  • Alcohol or drug abuse within the 12 months prior to screening
  • Trauma or surgical procedures requiring hospitalization within 8 weeks prior to Day 1
  • Planned elective surgery during the study including 9 weeks following the final dose of study drug
  • History of allergy against nucleoside analogs or human, humanized, chimeric, or murine monoclonal antibodies
  • Inability to cooperate with study personnel or a history of noncompliance to the medical regimen (i.e., subjects who would be expected to comply poorly with the treatment)
  • Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study
  • Morbid obesity (body mass index \[BMI\] \>40)
  • Inadequate IV access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Queen Mary Hospital

Pokfulam, Hong Kong Island, Hong Kong

Location

Ruttonjee Hospital

Wan Chai, Hong Kong Island, Hong Kong

Location

Princess Margaret Hospital

Kowloon, Kowloon, Hong Kong

Location

Prince of Wales Hospital

Shatin, Kowloon, Hong Kong

Location

Tuen Mun Hospital

New Territories, New Territories, Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

Location

Siriraj Hospital

Siriaj, Bangkok Noi, 10700, Thailand

Location

Songklanagarind Hospital

Amphur Hatyai, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital

Amphur Muang, Chiang Mai, 50200, Thailand

Location

MeSH Terms

Interventions

pamrevlumabentecavirDrugs, Generic

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

  • Frank Valone, MD

    Kyntra Bio

    STUDY CHAIR

  • Mairead Carney

    Kyntra Bio

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 8, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 16, 2016

Record last verified: 2016-08

Locations

HK(6)TH(3)