Liver Fibrosis Due to Chronic Hepatitis B InfectionPhase 2NCT01217632
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
A Phase 2 study testing FG-3019 and Entecavir in people with Liver Fibrosis Due to Chronic Hepatitis B Infection, run by Kyntra Bio at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Fibrosis Due to Chronic Hepatitis B Infection
- What is being tested?
- FG-3019 and Entecavir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Aug 2010to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Hong Kong6 sites
Princess Margaret Hospital
Kowloon, Kowloon
Tuen Mun Hospital
New Territories, New Territories
Queen Mary Hospital
Pokfulam, Hong Kong Island
Prince of Wales Hospital
Shatin, Kowloon
Alice Ho Miu Ling Nethersole Hospital
Tai Po
Ruttonjee Hospital
Wan Chai, Hong Kong Island
Thailand3 sites
Songklanagarind Hospital
Amphur Hatyai, Changwat Songkhla, 90110
Maharaj Nakorn Chiang Mai Hospital
Amphur Muang, Chiang Mai, 50200
Siriraj Hospital
Siriaj, Bangkok Noi, 10700
About this study
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
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.
- Being tested
- FG-3019, Placebo, Entecavir
- Keywords
- Connective tissue growth factor (CTGF), human IgG1 monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.
EntecavirDrug
Also called Entecavir Dispersible (generic)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Placebo; Drug: 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. Receives: Drug: FG-3019; Drug: Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: every 3 weeks for 45 weeks
Secondary outcomes (1)
To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population
Measured: every 3 weeks for 45 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Study terminated due to an unexpected prominent effect of entecavir alone in this patient population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Fibrosis Due to Chronic Hepatitis B InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Valone, MD, Study chair, Kyntra BioMairead Carney, Study director, Kyntra Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217632
- Sponsor's protocol ID
- FGCL-3019-801
- Status last verified
- Aug 2016
- First submitted
- 30 Sep 2010
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01217632
- Acronym / sponsor ID
- FGCL-3019-801
- Keywords
- Connective tissue growth factor (CTGF), human IgG1 monoclonal antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to an unexpected prominent effect of entecavir alone in this patient population.
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FG-3019 Placebo | Placebo comparator | Drug: Placebo, Drug: EntecavirPlacebo 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. |
| FG-3019 | Experimental | Drug: FG-3019, Drug: EntecavirFG-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FG-3019FG-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 |
| PlaceboPlacebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline. | Drug | FG-3019 Placebo |
| EntecavirAlso: Entecavir Dispersible (generic) | Drug | FG-3019, FG-3019 Placebo |
Primary outcome
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
Time frame: every 3 weeks for 45 weeks
1 secondary outcome
To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population
Time frame: every 3 weeks for 45 weeks
Results and safety
The study was stopped early (reason given: Study terminated due to an unexpected prominent effect of entecavir alone in this patient population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Valone, MD study chair
Kyntra Bio
Mairead Carney study director
Kyntra Bio
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FG-3019 and Entecavir in people with Liver Fibrosis Due to Chronic Hepatitis B Infection, run by Kyntra Bio at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Hong Kong, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated due to an unexpected prominent effect of entecavir alone in this patient population.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: every 3 weeks for 45 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.