A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

Sponsor

FibroGen (Industry)

Overall Status

Terminated

CT.gov ID

NCT01217632

Collaborator

(none)

114

Enrollment

Locations

Arms

Duration (Months)

12.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Fibrosis Due to Chronic Hepatitis B Infection	Drug: FG-3019 Drug: Placebo Drug: Entecavir	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

114 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: FG-3019 Placebo 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: Placebo Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline. Drug: Entecavir Other Names: Entecavir Dispersible (generic)
Experimental: FG-3019 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-3019 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: Entecavir Other Names: Entecavir Dispersible (generic)

Arm

Intervention/Treatment

Placebo Comparator: FG-3019 Placebo

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: Placebo

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

Drug: Entecavir

Other Names:

Entecavir Dispersible (generic)

Experimental: FG-3019

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-3019

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: Entecavir

Other Names:

Entecavir Dispersible (generic)

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population [every 3 weeks for 45 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Pokfulam	Hong Kong Island	Hong Kong
2	Ruttonjee Hospital	Wanchai	Hong Kong Island	Hong Kong
3	Prince of Wales Hospital	Shatin	Kowloon	Hong Kong
4	Princess Margaret Hospital	Kowloon		Hong Kong
5	Tuen Mun Hospital	New Territories		Hong Kong
6	Alice Ho Miu Ling Nethersole Hospital	Tai Po		Hong Kong
7	Siriraj Hospital	Siriaj	Bangkok Noi	Thailand	10700
8	Maharaj Nakorn Chiang Mai Hospital	Amphur Muang	Chiang Mai	Thailand	50200
9	Songklanagarind Hospital	Amphur Hatyai	Songkla	Thailand	90110