Clinical trial NCT01217632: A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Liver Fibrosis Due to Chronic Hepatitis B Infection
Keywords: Connective tissue growth factor (CTGF)
human IgG1 monoclonal antibody
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: every 3 weeks for 45 weeks
Secondary outcomes:
measure: To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population
timeFrame: every 3 weeks for 45 weeks
Other outcomes:
Locations:
city: Pokfulam
country: Hong Kong
facility: Queen Mary Hospital
state: Hong Kong Island
city: Wanchai
country: Hong Kong
facility: Ruttonjee Hospital
state: Hong Kong Island
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
state: Kowloon
city: Kowloon
country: Hong Kong
facility: Princess Margaret Hospital
city: New Territories
country: Hong Kong
facility: Tuen Mun Hospital
city: Tai Po
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Siriaj
country: Thailand
facility: Siriraj Hospital
state: Bangkok Noi
city: Amphur Muang
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Chiang Mai
city: Amphur Hatyai
country: Thailand
facility: Songklanagarind Hospital
state: Songkla
Study officials:
affiliation: FibroGen
name: Frank Valone, MD
role: STUDY_CHAIR
affiliation: FibroGen
name: Mairead Carney
role: STUDY_DIRECTOR
References: