Hepatitis B, ChronicPhase 4NCT02327663
Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
A Phase 4 study testing Emtricitabine in people with Hepatitis B, Chronic, run by Asian-Pacific Alliance of Liver Disease, Beijing.
Trial summary
This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Emtricitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HBsAg positive for more than 6 months
- HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
- HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
- HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
- HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
- nucleoside/nucleotide naive paitents
Who cannot join
- Diagnosed HCC with AFP and ultrasound, CT or MRI
- Creatine >130μmol/L or Ccr < 70mL/min
- Hemoglobin <100g/L
- Neutrophils <1.5E+9/L
- PLT<80E+9/L
- Coinfected with HAV,HEV,HCV,HDV or HIV
Show all 14Show fewer
- ANA > 1:100
- Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
- Drug abuse or alcohal addiction
- Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
- Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
- Underwent liver transplantation or liver transplantation in schedule
- Allergic to nucleoside or nucleotide analogues
- Preganency or in breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.
Read the detailed description
Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Emtricitabine
- Keywords
- Hepatitis B, chronic, Emtricitabine, Adefovir dipivixil, HBeAg
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmtricitabineDrug
Also called Brand name：Huierding
emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
| Study group | Role | What they receive |
|---|---|---|
| HBeAg positive CHB group | Experimental | 1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined Receives: Drug: Emtricitabine |
| HBeAg negativie CHB group | Experimental | 1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined Receives: Drug: Emtricitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
virological response rate
HBV DNA < 500 copies/ml
Measured: week 96
Secondary outcomes (10)
HBV DNA decrease level
HBV DNA decrease compared with baseline（log10 copies/ml）
Measured: week24, 48, 72 and 96
HBV DNA negativity rate
HBV DNA < 500 copies/ml
Measured: week 24, 48 and 72
biochemical response
ALT normalization
Measured: week 24,48,72 and 96
HBeAg loss
HBeAg loss in HBeAg positive group
Measured: week 24,48,72 and 96
HBeAg seroconversion
HBeAg seroconversion in HBeAg positive group
Measured: week 24,48,72 and 96
HBeAg reversion
HBeAg positive in Baseline HBeAg negativie group patients
Measured: week 24,48,72 and 96
HBsAg loss
HBsAg loss in both group
Measured: week 24,48,72 and 96
HBsAg seroconversion
HBsAg loss and anti-HBs positive
Measured: week 24,48,72 and 96
adverse event
type and rate of adverse events;type and rate of severe adverse event;
Measured: week 24,48,72 and 96
HBV genetic resistance to emtricitabine and adefovir
HBV genetic resistance to emtricitabine and adefovir
Measured: week 24,48,72 and 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian-Pacific Alliance of Liver Disease, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Ditan Hospital, Hebei Medical University Pharmaceutical Factory, National Health and Family Planning Commission, P.R.China
- Responsible party
- Principal investigator, Jun Cheng, Asian-Pacific Alliance of Liver Disease, Beijing
- Investigators
- Jun Cheng, M.D., Principal investigator, Asian Pacific Alliance of Liver Diseases, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327663
- Sponsor's protocol ID
- FTC-01
- Status last verified
- Dec 2014
- First submitted
- 23 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49.
PubMed 16401810Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. doi: 10.1128/AAC.46.6.1734-1740.2002.
PubMed 12019083
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emtricitabine for Naive Chinese Chronic Hepatitis B Patients
- ClinicalTrials.gov ID
- NCT02327663
- Acronym / sponsor ID
- FTC-01
- Conditions
- Hepatitis B, Chronic
- Keywords
- Hepatitis B, chronic, Emtricitabine, Adefovir dipivixil, HBeAg
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Asian-Pacific Alliance of Liver Disease, BeijingUniversity, hospital or other
- Collaborators
- Beijing Ditan Hospital, Hebei Medical University Pharmaceutical Factory, National Health and Family Planning Commission, P.R.China
- Study start
- Dec 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Dec 2014 (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.
This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.
Detailed description
Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HBeAg positive CHB group | Experimental | Drug: Emtricitabine1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined |
| HBeAg negativie CHB group | Experimental | Drug: Emtricitabine1000 patients take generic emtricitabine capsule(200 mg one time per day) for 96 weeks,and for patients who have HBV DNA > 500 copies/ml, adefovir dipivoxil were combined |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HBsAg positive for more than 6 months
- HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
- HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
- HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
- HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
Key exclusion criteria (14 listed)
- Diagnosed HCC with AFP and ultrasound, CT or MRI
- Creatine >130μmol/L or Ccr < 70mL/min
- Hemoglobin <100g/L
- Neutrophils <1.5E+9/L
- PLT<80E+9/L
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 |
|---|---|---|
| EmtricitabineAlso: Brand name：Huierdingemtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24 | Drug | HBeAg negativie CHB group, HBeAg positive CHB group |
Primary outcome
virological response rate
Time frame: week 96
HBV DNA < 500 copies/ml
10 secondary outcomes
HBV DNA decrease level
Time frame: week24, 48, 72 and 96
HBV DNA negativity rate
Time frame: week 24, 48 and 72
biochemical response
Time frame: week 24,48,72 and 96
HBeAg loss
Time frame: week 24,48,72 and 96
HBeAg seroconversion
Time frame: week 24,48,72 and 96
HBeAg reversion
Time frame: week 24,48,72 and 96
HBsAg loss
Time frame: week 24,48,72 and 96
HBsAg seroconversion
Time frame: week 24,48,72 and 96
adverse event
Time frame: week 24,48,72 and 96
HBV genetic resistance to emtricitabine and adefovir
Time frame: week 24,48,72 and 96
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
- Background: PubMed 16401810Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49.
- Results publication: PubMed 12019083Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. doi: 10.1128/AAC.46.6.1734-1740.2002.
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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.
Jun Cheng, M.D. principal investigator
Asian Pacific Alliance of Liver Diseases, Beijing
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Emtricitabine in people with Hepatitis B, Chronic, run by Asian-Pacific Alliance of Liver Disease, Beijing.
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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 30 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Cheng, M.D. (+86 10 84322116, jun.cheng.ditan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
virological response rate (time frame: week 96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327663, which also lists 2 linked publications.
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 30 Dec 2014.