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Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients

NCT01436539 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-09-19

No results posted yet for this study

Summary

The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic hepatitis B.

Conditions

Interventions

DRUG

Adefovir Dipivoxil and polyene phosphatidylcholine

Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks

DRUG

Adefovir Dipivoxil

Adefovir Dipivoxil 10 mg once daily for 48 weeks

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Fujian Cosunter Pharmaceutical Co. Ltd

    collaborator INDUSTRY

  • Jun Cheng

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2013-03-31
Completion
2013-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436539 on ClinicalTrials.gov