Chronic Hepatitis BPhase 4Dragon-ExNCT01829685
Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
A Phase 4 study testing Entecavir, Adefovir in people with Chronic Hepatitis B and Inadequate Response, run by Nanfang Hospital, Southern Medical University at 16 sites in China.
Trial summary
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d 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
- Chronic Hepatitis B, Inadequate Response, Nucleos(t)Ide Analogues Treatment
- What is being tested?
- 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
- Mar 2013to Jun 2016
- 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
- Subjects who completed the 104-week Dragon study.
- Subjects who are willing to participate the extension study.
Who cannot join
- Subjects who could not compliance with the protocol judged by investigators
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites
Beijing Ditan Hospital
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
Shengyang, Liaoning
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy
- Being tested
- Entecavir, Adefovir
- 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.
Entecavir, AdefovirDrug
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks Receives: Drug: Entecavir, Adefovir |
| Group II | Active comparator | oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks Receives: Drug: Entecavir, Adefovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
Measured: Week 144
Secondary outcomes (4)
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
Measured: Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
Measured: Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Measured: Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Measured: Week 48 & 96 & 144
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Major Science and Technology Special Project of China Eleventh Five-year
- Responsible party
- Sponsor
- Investigators
- Jinlin Hou, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829685
- Sponsor's protocol ID
- MOH-06
- Acronym
- Dragon-Ex
- Status last verified
- Jun 2014
- First submitted
- 9 Apr 2013
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li Y, Pan CQ, Ji S, Yan G, Cheng J, Liu S, Xing H. Serum IL-21 levels predict HBeAg decline during rescue therapy in patients with partial response to nucleos(t)ide analogues. Exp Ther Med. 2021 Mar;21(3):216. doi: 10.3892/etm.2021.9648. Epub 2021 Jan 15.
PubMed 33500704
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study
- ClinicalTrials.gov ID
- NCT01829685
- Acronym / sponsor ID
- Dragon-Ex / MOH-06
- 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
- Major Science and Technology Special Project of China Eleventh Five-year
- Study start
- Mar 2013
- Primary completion
- Jun 2016 (estimated)
- First posted
- 11 Apr 2013 (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 compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Entecavir, Adefoviroral entecavir 1mg daily and adefovir 10mg daily for 144 weeks |
| Group II | Active comparator | Drug: Entecavir, Adefoviroral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who completed the 104-week Dragon study.
- Subjects who are willing to participate the extension study.
Key exclusion criteria (1 listed)
- Subjects who could not compliance with the protocol judged by investigators
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 |
|---|---|---|
| Entecavir, Adefovir | Drug | Group I, Group II |
Primary outcome
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
Time frame: Week 144
4 secondary outcomes
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
Time frame: Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
Time frame: Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Time frame: Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Time frame: Week 48 & 96 & 144
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
- Derived from this study: PubMed 33500704Li Y, Pan CQ, Ji S, Yan G, Cheng J, Liu S, Xing H. Serum IL-21 levels predict HBeAg decline during rescue therapy in patients with partial response to nucleos(t)ide analogues. Exp Ther Med. 2021 Mar;21(3):216. doi: 10.3892/etm.2021.9648. Epub 2021 Jan 15.
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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, Adefovir in people with Chronic Hepatitis B and Inadequate Response, 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 2 inclusion and 1 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 19 Jun 2014. 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?
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group (time frame: Week 144). 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 NCT01829685, which also lists 1 linked publication.
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 19 Jun 2014.