Hepatitis BPhase 4NCT01998620
Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
A Phase 4 study testing Ademetionine 2, Ademetionine 1 and Ademetionine 3 in people with Hepatitis B and Cholestasis, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Cholestasis
- What is being tested?
- Ademetionine 2, Ademetionine 1 and Ademetionine 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to May 2015
- 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
- from 18-65 years old
- diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
- with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN
Who cannot join
- liver mass, liver carcinoma
- liver failure
- non-hepatic diseases caused jaundice
- obstructive jaundice
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Public Health Clinical Center Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200000
Liang Chen, Doctor, 00862137990333, chenlian@shaphl.org
About this study
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
Read the detailed description
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety
- Conditions
- Hepatitis B, Cholestasis
- Being tested
- Ademetionine 2, Ademetionine 1, Ademetionine 3
- Keywords
- Hepatitis B, Cholestasis
- Medical subject headings
- Hepatitis B, Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ademetionine 2Drug
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
Ademetionine 1Drug
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Ademetionine 3Drug
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ademetionine 1 | Experimental | Ademetionine 2000mg Receives: Drug: Ademetionine 1 |
| Ademetionine 2 | Experimental | Ademetionine 1000mg Receives: Drug: Ademetionine 2 |
| Ademetionine 3 | Active comparator | no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks Receives: Drug: Ademetionine 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of serum total bilirubin declined from baseline
levels of serum total bilirubin declined from baseline
Measured: 2 weeks
Alkaline Phosphatase
Alkaline Phosphatase
Measured: 10 weeks
Gamma-Glutamyl Transpeptidase
Gamma-Glutamyl Transpeptidase
Measured: 10 weeks
Secondary outcomes (4)
level of serum direct bilirubin decline from baseline
level of serum direct bilirubin decline from baseline
Measured: 2 weeks, 6 weeks, 10 weeks
level of serum bile acids decline from baseline
level of serum bile acids decline from baseline
Measured: 2 weeks, 6 weeks, 10 weeks
glutamic pyruvic transaminase
glutamic pyruvic transaminase
Measured: 2 weeks, 6 weeks, 10 weeks
glutamic oxaloacetic transaminase
glutamic oxaloacetic transaminase
Measured: 2 weeks, 6 weeks, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (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.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liang Chen, Principal investigator, Public Health Clinical Center Affiliated to Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998620
- Sponsor's protocol ID
- XMX-HBV-001
- Status last verified
- May 2014
- First submitted
- 14 Nov 2013
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
- ClinicalTrials.gov ID
- NCT01998620
- Acronym / sponsor ID
- XMX-HBV-001
- Conditions
- Hepatitis B, Cholestasis
- Keywords
- Hepatitis B, Cholestasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 2 Dec 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.
This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
Detailed description
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ademetionine 1 | Experimental | Drug: Ademetionine 1Ademetionine 2000mg |
| Ademetionine 2 | Experimental | Drug: Ademetionine 2Ademetionine 1000mg |
| Ademetionine 3 | Active comparator | Drug: Ademetionine 3no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- from 18-65 years old
- diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
- with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN
Key exclusion criteria (4 listed)
- liver mass, liver carcinoma
- liver failure
- non-hepatic diseases caused jaundice
- obstructive jaundice
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 |
|---|---|---|
| Ademetionine 2Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks | Drug | Ademetionine 2 |
| Ademetionine 1Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks | Drug | Ademetionine 1 |
| Ademetionine 3no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks | Drug | Ademetionine 3 |
Primary outcome
levels of serum total bilirubin declined from baseline
Time frame: 2 weeks
levels of serum total bilirubin declined from baseline
Alkaline Phosphatase
Time frame: 10 weeks
Alkaline Phosphatase
Gamma-Glutamyl Transpeptidase
Time frame: 10 weeks
Gamma-Glutamyl Transpeptidase
4 secondary outcomes
level of serum direct bilirubin decline from baseline
Time frame: 2 weeks, 6 weeks, 10 weeks
level of serum bile acids decline from baseline
Time frame: 2 weeks, 6 weeks, 10 weeks
glutamic pyruvic transaminase
Time frame: 2 weeks, 6 weeks, 10 weeks
glutamic oxaloacetic transaminase
Time frame: 2 weeks, 6 weeks, 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2014.
Related trials for Hepatitis B
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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.
Liang Chen principal investigator
Public Health Clinical Center Affiliated to Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ademetionine 2, Ademetionine 1 and Ademetionine 3 in people with Hepatitis B and Cholestasis, run by Zhejiang Hisun Pharmaceutical Co. Ltd. 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 3 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 29 May 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.
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 Liang Chen (00862137990333, chenlian@shaphl.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of serum total bilirubin declined from baseline (time frame: 2 weeks). The study lists 3 primary outcomes in all. 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 29 May 2014.