Hepatitis B, ChronicPhase 4NCT02327689
Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
A Phase 4 study testing Emtricitabine plus adefovir dipivoxil in people with Hepatitis B, Chronic and Fibrosis, run by Asian-Pacific Alliance of Liver Disease, Beijing.
Trial summary
This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Chronic, Fibrosis
- What is being tested?
- Emtricitabine plus adefovir dipivoxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 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
- Dignosed cirrhosis patients
- HBsAg positive for more than 6 months
- HBV DNA detectable
- Nucleoside/nucleotide naive patients
Who cannot join
- Diagnosed HCC with AFP and ultrasound, CT or MRI
- Creatine >130μmol/L or Ccr < 70mL/min
- Hemoglobin <100g/L
- Coinfected with HAV,HEV,HCV,HDV or HIV
- ANA > 1:100
- Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer;
Show all 12Show fewer
- Drug abuse or alcohol 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
- Pregnancy or in breastfeeding
Trial locations and contacts
No sites are listed yet.
About this study
This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.
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 plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.
- Conditions
- Hepatitis B, Chronic, Fibrosis
- Being tested
- Emtricitabine plus adefovir dipivoxil
- Keywords
- Hepatitis B virus, Cirrhosis, Emtricitabine, Adefovir dipivoxil
- Medical subject headings
- Hepatitis B, Chronic, Fibrosis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emtricitabine plus adefovir dipivoxilDrug
Also called Brand name of emtricitabine：Huierding
emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks
| Study group | Role | What they receive |
|---|---|---|
| compensated HBV related cirrhosis patients | Experimental | Chinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks Receives: Drug: Emtricitabine plus adefovir dipivoxil |
| decompensated HBV related cirrhosis patients | Experimental | Chinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks Receives: Drug: Emtricitabine plus adefovir dipivoxil |
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 (12)
HBV DNA negativity rate
HBV DNA < 500 copies/ml
Measured: week 24, 48 and 72
HBV DNA decrease level
HBV DNA decrease compared with baseline（log10 copies/ml）
Measured: week24, 48, 72 and 96
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
HBV genetic resistance to emtricitabine and adefovir
HBV genetic resistance to emtricitabine and adefovir
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
incidence of HCC
incidence of HCC in both groups
Measured: week 24,48,72 and 96
change of MELD score and Child-Pugh score
change of MELD score and Child-Pugh score in both groups
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 startJan 2015
- Primary completionJul 2015 (estimated)
- Study completionJul 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
- 400 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
- Sponsor
- Investigators
- Jun Cheng, M.D., Principal investigator, Asian Pacific Alliance of Liver Diseases, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327689
- Sponsor's protocol ID
- FTC-01-cirrhosis patients
- Status last verified
- Dec 2014
- First submitted
- 23 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gish 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 12019083Lim 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 16401810
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 Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
- ClinicalTrials.gov ID
- NCT02327689
- Acronym / sponsor ID
- FTC-01-cirrhosis patients
- Conditions
- Hepatitis B, Chronic, Fibrosis
- Keywords
- Hepatitis B virus, Cirrhosis, Emtricitabine, Adefovir dipivoxil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 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
- Jan 2015
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Jul 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) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.
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 plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| compensated HBV related cirrhosis patients | Experimental | Drug: Emtricitabine plus adefovir dipivoxilChinese naive compensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks |
| decompensated HBV related cirrhosis patients | Experimental | Drug: Emtricitabine plus adefovir dipivoxilChinese naive decompensated HBV related cirrhosis patients were treated with generic emtricitabine capsule(200 mg one time per day) plus adefovir dipivoxil(10 mg one time per day) for 96 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Dignosed cirrhosis patients
- HBsAg positive for more than 6 months
- HBV DNA detectable
- Nucleoside/nucleotide naive patients
Key exclusion criteria (12 listed)
- Diagnosed HCC with AFP and ultrasound, CT or MRI
- Creatine >130μmol/L or Ccr < 70mL/min
- Hemoglobin <100g/L
- Coinfected with HAV,HEV,HCV,HDV or HIV
- ANA > 1:100
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 |
|---|---|---|
| Emtricitabine plus adefovir dipivoxilAlso: Brand name of emtricitabine：Huierdingemtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks | Drug | compensated HBV related cirrhosis patients, decompensated HBV related cirrhosis patients |
Primary outcome
virological response rate
Time frame: week 96
HBV DNA < 500 copies/ml
12 secondary outcomes
HBV DNA negativity rate
Time frame: week 24, 48 and 72
HBV DNA decrease level
Time frame: week24, 48, 72 and 96
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
HBV genetic resistance to emtricitabine and adefovir
Time frame: week 24,48,72 and 96
adverse event
Time frame: week 24,48,72 and 96
incidence of HCC
Time frame: week 24,48,72 and 96
change of MELD score and Child-Pugh score
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 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.
- 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.
Related trials for Hepatitis B, Chronic
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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 plus adefovir dipivoxil in people with Hepatitis B, Chronic and Fibrosis, 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 4 inclusion and 12 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 NCT02327689, 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.