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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01998620
• Other study ID #: XMX-HBV-001
• Status: Recruiting
• Phase: Phase 4
• First received: November 14, 2013
• Last updated: May 28, 2014
• Start date: November 2013
• Est. completion date: May 2015

Study information

• Verified date: May 2014
• Source: Zhejiang Hisun Pharmaceutical Co. Ltd.
• Contact: Liang Chen
• Phone: 00862137990333
• Email: chenlian[@]shaphl.org
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Description:

evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholestasis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ademetionine 2
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
• Ademetionine 1
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
• Ademetionine 3
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks

Locations

Country	Name	City	State
China	Public Health Clinical Center Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Hisun Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of serum total bilirubin declined from baseline	levels of serum total bilirubin declined from baseline	2 weeks	Yes
Primary	Alkaline Phosphatase	Alkaline Phosphatase	10 weeks	Yes
Primary	Gamma-Glutamyl Transpeptidase	Gamma-Glutamyl Transpeptidase	10 weeks	Yes
Secondary	level of serum direct bilirubin decline from baseline	level of serum direct bilirubin decline from baseline	2 weeks, 6 weeks, 10 weeks	Yes
Secondary	level of serum bile acids decline from baseline	level of serum bile acids decline from baseline	2 weeks, 6 weeks, 10 weeks	Yes
Secondary	glutamic pyruvic transaminase	glutamic pyruvic transaminase	2 weeks, 6 weeks, 10 weeks	Yes
Secondary	glutamic oxaloacetic transaminase	glutamic oxaloacetic transaminase	2 weeks, 6 weeks, 10 weeks	Yes