Hepatitis B, ChronicNCT02075294
Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
An observational study of Hepatitis B, Chronic, run by Ying-Jie Ji at 1 site in China.
Trial summary
It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. 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?
- Adefovir dipivoxil or Entecavir
- Type of treatment
- Pill or oral medicine
- How many people
- 242 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Oct 2012
- Phase
- Observational
- 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
Study population: We retrospectively analyzed a consecutive cohort of chronic hepatitis B patients treated with ADV, 10mg, daily, or with ETV，0.5mg，daily between January 2010 and December 2013 in a single tererral referral hospital in Beijing. Data were retrieved from a prospectively maintined database.
Who may be able to join
- Age≥18 years
- HBsAg positive for more than 6 months before enrollment
- Serum HBVDNA >2×104IU/ml and serum ALT >80U/L or TBIL < 34 umol/L for chronic hepatitis B
- Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
- Serum HBVDNA >40 IU/ml for cirrhosis regardless of ALT and TBIL
Who cannot join
- Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
- received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
- Renal function: creatinine >1.5 ULN or eGFR< 50ml/min/1.73m2 before therapy
- Combined with hepatocarcinoma before therapy
- suspend therapy voluntarily
- use other nephrotoxic drugs
Trial locations and contacts
1 site in 1 country.
China1 site
302 military hospital of China
Beijing, Beijing Municipality, 100039
About this study
It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one of the longer average life spans, and the size of the aged population has been increasing rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the potential for development of cirrhosis or hepatocellular carcinoma in such patients is real. Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has become first choice due to the more side effect of INF and the resistant of LAM and LdT. But treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the emergence rate of side effect.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Adefovir dipivoxil or Entecavir
- Keywords
- Aged, Hepatitis B, Chronic, Antiviral Agents
- 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.
Adefovir dipivoxil or EntecavirDrug
Also called ADV, Hepsera,, ETV, Baraclude
Adefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines.
Entecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines
| Study group | Role | What they receive |
|---|---|---|
| youth | <45years
Adefovir dipivoxil or Entecavir
Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.
Participants who received 0.5mg ETV more than 3 years will be recruited. Receives: Drug: Adefovir dipivoxil or Entecavir | |
| middle age | ≥45years and<65years
Adefovir dipivoxil or Entecavir
Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.
Participants who received 0.5mg ETV more than 3 years will be recruited. Receives: Drug: Adefovir dipivoxil or Entecavir | |
| elderly | ≥65 years
Adefovir dipivoxil or Entecavir
Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.
Participants who received 0.5mg ETV more than 3 years will be recruited. Receives: Drug: Adefovir dipivoxil or Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rates of serum HBVDNA undetectable and Renal dysfunction
Measured: 3years
Secondary outcomes (4)
the rate of normalisation of ALT
Measured: at week 2、4、12、24、36、48、60、72、84、96
the rate of HBsAg negative
Measured: at week48、96、144
the rate of HBeAg seroconversion
Measured: at week 24、48、72、96、120、144
the rate of HBeAg negative
Measured: at week 24、48、72、96、120、144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJan 2010
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ying-Jie Ji
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying-Jie Ji, Beijing 302 Hospital
- Investigators
- Ying-Jie Ji, MD., Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075294
- Sponsor's protocol ID
- YNKT201313
- Status last verified
- Oct 2014
- First submitted
- 27 Feb 2014
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT02075294
- Acronym / sponsor ID
- YNKT201313
- Conditions
- Hepatitis B, Chronic
- Keywords
- Aged, Hepatitis B, Chronic, Antiviral Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Ying-Jie JiUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 3 Mar 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.
It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one of the longer average life spans, and the size of the aged population has been increasing rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the potential for development of cirrhosis or hepatocellular carcinoma in such patients is real. Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has become first choice due to the more side effect of INF and the resistant of LAM and LdT. But treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the emergence rate of side effect.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| youth | – | Drug: Adefovir dipivoxil or Entecavir<45years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited. |
| middle age | – | Drug: Adefovir dipivoxil or Entecavir≥45years and<65years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited. |
| elderly | – | Drug: Adefovir dipivoxil or Entecavir≥65 years Adefovir dipivoxil or Entecavir Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited. Participants who received 0.5mg ETV more than 3 years will be recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively analyzed a consecutive cohort of chronic hepatitis B patients treated with ADV, 10mg, daily, or with ETV，0.5mg，daily between January 2010 and December 2013 in a single tererral referral hospital in Beijing. Data were retrieved from a prospectively maintined database.
Key inclusion criteria (5 listed)
- Age≥18 years
- HBsAg positive for more than 6 months before enrollment
- Serum HBVDNA >2×104IU/ml and serum ALT >80U/L or TBIL < 34 umol/L for chronic hepatitis B
- Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
- Serum HBVDNA >40 IU/ml for cirrhosis regardless of ALT and TBIL
Key exclusion criteria (6 listed)
- Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
- received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
- Renal function: creatinine >1.5 ULN or eGFR< 50ml/min/1.73m2 before therapy
- Combined with hepatocarcinoma before therapy
- suspend therapy voluntarily
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 |
|---|---|---|
| Adefovir dipivoxil or EntecavirAlso: ADV, Hepsera,, ETV, BaracludeAdefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines. Entecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines | Drug | elderly, middle age, youth |
Primary outcome
the rates of serum HBVDNA undetectable and Renal dysfunction
Time frame: 3years
4 secondary outcomes
the rate of normalisation of ALT
Time frame: at week 2、4、12、24、36、48、60、72、84、96
the rate of HBsAg negative
Time frame: at week48、96、144
the rate of HBeAg seroconversion
Time frame: at week 24、48、72、96、120、144
the rate of HBeAg negative
Time frame: at week 24、48、72、96、120、144
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
- Click here for more recruit information about this studyLink provided by the sponsor.
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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.
Ying-Jie Ji, MD. principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Ying-Jie Ji at 1 site in China.
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 6 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: finished, as of the sponsor's last update on 28 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the rates of serum HBVDNA undetectable and Renal dysfunction (time frame: 3years). 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 28 Oct 2014.