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Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

Primary Purpose

Hepatitis B, Cholestasis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ademetionine 2
Ademetionine 1
Ademetionine 3
Sponsored by
Zhejiang Hisun Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Hepatitis B, Cholestasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. from 18-65 years old
  2. diagnosed as hepatitis B, previous has HBV or HBsAg(+)>6 months, and now HBsAg or HBV DNA(+)
  3. with intrahepatic cholestasis: meet EASL 2009 diagnoses criteria ALP>1.5ULN and GGT>3ULN or STB>2ULN

Exclusion Criteria:

  1. liver mass, liver carcinoma
  2. liver failure
  3. non-hepatic diseases caused jaundice
  4. obstructive jaundice

Sites / Locations

  • Public Health Clinical Center Affiliated to Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Ademetionine 1

Ademetionine 2

Ademetionine 3

Arm Description

Ademetionine 2000mg

Ademetionine 1000mg

no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Outcomes

Primary Outcome Measures

levels of serum total bilirubin declined from baseline
levels of serum total bilirubin declined from baseline
Alkaline Phosphatase
Alkaline Phosphatase
Gamma-Glutamyl Transpeptidase
Gamma-Glutamyl Transpeptidase

Secondary Outcome Measures

level of serum direct bilirubin decline from baseline
level of serum direct bilirubin decline from baseline
level of serum bile acids decline from baseline
level of serum bile acids decline from baseline
glutamic pyruvic transaminase
glutamic pyruvic transaminase
glutamic oxaloacetic transaminase
glutamic oxaloacetic transaminase

Full Information

First Posted
November 14, 2013
Last Updated
May 28, 2014
Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01998620
Brief Title
Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
Official Title
Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
May 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Hisun Pharmaceutical Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Cholestasis
Keywords
Hepatitis B, Cholestasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ademetionine 1
Arm Type
Experimental
Arm Description
Ademetionine 2000mg
Arm Title
Ademetionine 2
Arm Type
Experimental
Arm Description
Ademetionine 1000mg
Arm Title
Ademetionine 3
Arm Type
Active Comparator
Arm Description
no treatment in first 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ademetionine 2
Intervention Description
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ademetionine 1
Intervention Description
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Ademetionine 3
Intervention Description
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Primary Outcome Measure Information:
Title
levels of serum total bilirubin declined from baseline
Description
levels of serum total bilirubin declined from baseline
Time Frame
2 weeks
Title
Alkaline Phosphatase
Description
Alkaline Phosphatase
Time Frame
10 weeks
Title
Gamma-Glutamyl Transpeptidase
Description
Gamma-Glutamyl Transpeptidase
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
level of serum direct bilirubin decline from baseline
Description
level of serum direct bilirubin decline from baseline
Time Frame
2 weeks, 6 weeks, 10 weeks
Title
level of serum bile acids decline from baseline
Description
level of serum bile acids decline from baseline
Time Frame
2 weeks, 6 weeks, 10 weeks
Title
glutamic pyruvic transaminase
Description
glutamic pyruvic transaminase
Time Frame
2 weeks, 6 weeks, 10 weeks
Title
glutamic oxaloacetic transaminase
Description
glutamic oxaloacetic transaminase
Time Frame
2 weeks, 6 weeks, 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: liver mass, liver carcinoma liver failure non-hepatic diseases caused jaundice obstructive jaundice
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Chen
Phone
00862137990333
Email
chenlian@shaphl.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Chen
Organizational Affiliation
Public Health Clinical Center Affiliated to Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Public Health Clinical Center Affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Chen, Doctor
Phone
00862137990333
Email
chenlian@shaphl.org

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of S-adenosyl-L-methionine in Treatment of Chronic Hepatitis B Patients With Cholestasis

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