Efficacy and Safety of S-adenosyl-l-methionine in Treatme... | NCT02024295

Studies
Efficacy and Safety of S-adenosyl-l-methionine in Treatment of Alcoholic Hepatitis With Cholestasis

NCT02024295

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Status

Unknown status

Last Update Posted

May 29, 2014Estimated

Enrollment

118Estimated

Phase

Phase 4

Conditions

Hepatitis, Alcoholic

Interventions

Ademethionine
Polyene Phosphatidyl choline
Ademethionine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 19, 2013

First Submission Date that Met QC Criteria

Dec 25, 2013

First Posted Date

Dec 31, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2014

Last Update Posted Date

May 29, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

118Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ademethionine	Experimental	ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.	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.	Drug: Polyene Phosphatidyl choline Drug: Ademethionine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ademethionine	Drug	ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.	Ademethionine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
response rate of serum total bilirubin	response rate means percentage of subjects whose serum total bilirubin values declined from baseline over 30%	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
level of serum direct bilirubin		6 weeks and 48 weeks
level of serum bile acids		6 weeks and 48 weeks
level of glutamic pyruvic transaminase

Other Outcomes

Measure	Description	Time Frame
Liver biopsy	Liver biopsy is not demanded	48 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria: any one of below,

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Cheng	Contact	8610-84322000		jun.cheng.ditan@gmail.com

Overall Officials

Name	Affiliation	Role
Jun Cheng	Beijing Ditan Hospital affiliated ffiated to Capital Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Ditan Hospital	Recruiting	Beijing	Beijing Municipality	100015	China

Condition Browse Module

MeSH Terms

ID	Term
D006519	Hepatitis, Alcoholic

Ancestor Terms

ID	Term
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases
D008108	Liver Diseases, Alcoholic

Browse Leaves

Not provided

Browse Branches

Not provided