Hepatitis, AlcoholicPhase 4NCT02024295
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis
A Phase 4 study testing Ademethionine and Polyene Phosphatidyl choline in people with Hepatitis, Alcoholic, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 2 sites in China.
Trial summary
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hepatitis, Alcoholic
- What is being tested?
- Ademethionine and Polyene Phosphatidyl choline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesChina
- Study dates
- Dec 2013to Dec 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index range 19-30kg/m2
- Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day;
- STB from 2 to 10X ULN;
- ALP>1.5X ULN or GGT>3X ULN
Who cannot join
- active virus hepatitis, or anti-HIV(+)
- exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis
- other non-hepatic diseases caused jaundice
- primary hepatic carcinoma
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Beijing Ditan Hospital
Beijing, Beijing Municipality, 100015
Jun Cheng, 8610-84322566, jun.cheng.ditan@gmail.com
- Recruiting
Jun Cheng
Beijing, Beijing Municipality, 100015
Jun Cheng
About this study
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.
Read the detailed description
randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.
- Conditions
- Hepatitis, Alcoholic
- Being tested
- Ademethionine, Polyene Phosphatidyl choline
- Medical subject headings
- Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdemethionineDrug
Also called ademethionine for 6 weeks
ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
Polyene Phosphatidyl cholineDrug
Also called Polyene Phosphatidyl choline for 6 weeks
Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
AdemethionineDrug
Also called stage 2, ademethionine for 42 weeks.
after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ademethionine | Experimental | ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks. Receives: Drug: Ademethionine |
| Polyene Phosphatidyl choline | Active comparator | Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks. Receives: Drug: Polyene Phosphatidyl choline; Drug: Ademethionine |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate of serum total bilirubin
response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%
Measured: 6 weeks
Secondary outcomes (7)
level of serum direct bilirubin
Measured: 6 weeks and 48 weeks
level of serum bile acids
Measured: 6 weeks and 48 weeks
level of glutamic pyruvic transaminase
Measured: 6 weeks and 48 weeks
level of glutamic oxaloacetic transaminase
Measured: 6 weeks and 48 weeks
level of alkaline phosphatase
Measured: 6 weeks and 48 weeks
level of gamma-glutamyl transpeptidase
Measured: 6 weeks and 48 weeks
level of hyaluronic acid
Measured: 6 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, AlcoholicStudies 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
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Cheng, Principal investigator, Beijing Ditan Hospital affiliated ffiated to Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02024295
- Sponsor's protocol ID
- XMX-AH-001
- Status last verified
- May 2014
- First submitted
- 19 Dec 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 Alcoholic Hepatitis With Cholestasis
- ClinicalTrials.gov ID
- NCT02024295
- Acronym / sponsor ID
- XMX-AH-001
- Conditions
- Hepatitis, Alcoholic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Zhejiang Hisun Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 31 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.
To determine the efficacy and safety S-adenosyl-l-methionine in alcoholic hepatitis with cholestasis.
Detailed description
randomize first time for core treatment stage for 6 weeks, then randomized second time for extend treatment for 42 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ademethionine | Experimental | Drug: Ademethionineademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks. |
| Polyene Phosphatidyl choline | Active comparator | Drug: Polyene Phosphatidyl choline, Drug: AdemethioninePolyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Body Mass Index range 19-30kg/m2
- Alcohol Drinking history more than 5 years, for male ≥ 40g/ day, for female ≥ 20g/ day;
- STB from 2 to 10X ULN;
- ALP>1.5X ULN or GGT>3X ULN
Key exclusion criteria (4 listed)
- active virus hepatitis, or anti-HIV(+)
- exclude other hepatic disease: non-alcoholic fatty liver, drug-induced liver injury, autoimmune hepatitis( AMA/ANA>1:100), Wilson disease, hemochromatosis or other hepatic disease; obstructive cholestasis
- other non-hepatic diseases caused jaundice
- primary hepatic carcinoma
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 |
|---|---|---|
| AdemethionineAlso: ademethionine for 6 weeksademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks. | Drug | Ademethionine |
| Polyene Phosphatidyl cholineAlso: Polyene Phosphatidyl choline for 6 weeksPolyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks. | Drug | Polyene Phosphatidyl choline |
| AdemethionineAlso: stage 2, ademethionine for 42 weeks.after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks | Drug | Ademethionine, Polyene Phosphatidyl choline |
Primary outcome
response rate of serum total bilirubin
Time frame: 6 weeks
response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%
7 secondary outcomes
level of serum direct bilirubin
Time frame: 6 weeks and 48 weeks
level of serum bile acids
Time frame: 6 weeks and 48 weeks
level of glutamic pyruvic transaminase
Time frame: 6 weeks and 48 weeks
level of glutamic oxaloacetic transaminase
Time frame: 6 weeks and 48 weeks
level of alkaline phosphatase
Time frame: 6 weeks and 48 weeks
level of gamma-glutamyl transpeptidase
Time frame: 6 weeks and 48 weeks
level of hyaluronic acid
Time frame: 6 weeks and 48 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.
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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.
Jun Cheng principal investigator
Beijing Ditan Hospital affiliated ffiated to Capital Medical University
2 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 Ademethionine and Polyene Phosphatidyl choline in people with Hepatitis, Alcoholic, run by Zhejiang Hisun Pharmaceutical Co. Ltd. at 2 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 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 2 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?
Contact Jun Cheng (8610-84322000, 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?
response rate of serum total bilirubin (time frame: 6 weeks). 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.