Hepatitis BPhase 4NCT01341743
Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
A Phase 4 study testing Entecavir and Entecavir, Adefovir in people with Hepatitis B, run by Nanfang Hospital, Southern Medical University at 16 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Entecavir and Entecavir, Adefovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 16 sitesChina
- Study dates
- Dec 2010to Dec 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18-65 years;
- Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
- Serum HBsAg positive and ALT<10ULN at study screening;
- Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;
Who cannot join
- History of viral breakthrough or genotypic resistance on previous therapy;
- History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
- Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
- Other protocol defined exclusion criteria.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Ditan Hospita
Beijing, Beijing Municipality
Beijing Friendship Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality
People'S Hospital Under Beijnig University
Beijing, Beijing Municipality
First Hospital .Jilin Unniversity
Changchun, Jilin
Xiangya Hospital Central-South Univrsity
Changsha, Hunan
The First People's Hospital of Foshan
Foshan, Guangdong
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Department of infectious disease, Nanfang Hospital
Guangzhou, Guangdong
GuangDong Provincial People's hospital
Guangzhou, Guangdong
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai Municipality
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality
ShengJing Hospital of China Medical University
Shenyang, Liaoning
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
- Conditions
- Hepatitis B
- Being tested
- Entecavir, Entecavir, Adefovir
- Keywords
- chronic hepatitis B, inadequate response, NUC therapy
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
patients will receive oral entecavir 1mg, daily for 104 weeks.
Entecavir, AdefovirDrug
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Entecavir, AdefovirDrug
patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | oral entecavir 1mg daily for 104 weeks Receives: Drug: Entecavir |
| B | Active comparator | oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks Receives: Drug: Entecavir, Adefovir |
| C | Active comparator | oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks Receives: Drug: Entecavir, Adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
Measured: week 104
Secondary outcomes (5)
serum HBV DNA reduction from baseline at week 104
Measured: week 104
The proportion of subjects with ALT normalization at week 104
Measured: week104
The proportion of subjects with HBeAg loss and seroconversion at week 104
Measured: week104
The proportion of subject with HBsAg loss and seroconversion at week 104
Measured: week104
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
Measured: week104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
- Responsible party
- Sponsor
- Investigators
- JinLin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341743
- Sponsor's protocol ID
- MOH-04
- Status last verified
- Sep 2013
- First submitted
- 16 Feb 2011
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
- ClinicalTrials.gov ID
- NCT01341743
- Acronym / sponsor ID
- MOH-04
- Conditions
- Hepatitis B
- Keywords
- chronic hepatitis B, inadequate response, NUC therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
- Study start
- Dec 2010
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Apr 2011 (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 purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Entecaviroral entecavir 1mg daily for 104 weeks |
| B | Active comparator | Drug: Entecavir, Adefoviroral entecavir 1mg daily and adefovir 10mg daily for 104 weeks |
| C | Active comparator | Drug: Entecavir, Adefoviroral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female aged 18-65 years;
- Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
- Serum HBsAg positive and ALT<10ULN at study screening;
- Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;
Key exclusion criteria (4 listed)
- History of viral breakthrough or genotypic resistance on previous therapy;
- History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
- Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
- Other protocol defined exclusion criteria.
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 |
|---|---|---|
| Entecavirpatients will receive oral entecavir 1mg, daily for 104 weeks. | Drug | A |
| Entecavir, Adefovirpatients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks | Drug | B |
| Entecavir, Adefovirpatients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks | Drug | C |
Primary outcome
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
Time frame: week 104
5 secondary outcomes
serum HBV DNA reduction from baseline at week 104
Time frame: week 104
The proportion of subjects with ALT normalization at week 104
Time frame: week104
The proportion of subjects with HBeAg loss and seroconversion at week 104
Time frame: week104
The proportion of subject with HBsAg loss and seroconversion at week 104
Time frame: week104
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
Time frame: week104
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
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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.
JinLin Hou, MD principal investigator
Nanfang Hospital, Southern Medical University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir and Entecavir, Adefovir in people with Hepatitis B, run by Nanfang Hospital, Southern Medical University at 16 sites 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 4 inclusion and 4 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 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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.
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?
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?
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 (time frame: week 104). 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 30 Oct 2013.