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Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

NCT05355467 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-05-02

No results posted yet for this study

Summary

This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.

Conditions

  • Chronic Hepatitis B Infection

Interventions

DRUG

Tenofovir disoproxil fumarate

Ricovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks.

OTHER

Historical Data

Historical Data

Sponsors & Collaborators

  • Mylan (Taiwan) Ltd

    lead INDUSTRY

Principal Investigators

  • Sanjay Hadigal, Dr. · Mylan Pharmaceuticals Private Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-21
Primary Completion
2021-07-13
Completion
2021-07-13

Countries

  • Taiwan

Study Locations

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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 NCT05355467 on ClinicalTrials.gov