UnknownPhase 4

Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

400 participantsStarted 2015-01

Plain-language summary

This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Dignosed cirrhosis patients * HBsAg positive for more than 6 months * HBV DNA detectable * Nucleoside/nucleotide naive patients Exclusion Criteria: * Diagnosed HCC with AFP and ultrasound, CT or MRI * Creatine \>130μmol/L or Ccr \< 70mL/min * Hemoglobin \<100g/L * Coinfected with HAV,HEV,HCV,HDV or HIV * ANA \> 1:100 * Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer; * Drug abuse or alcohol addiction * Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine * Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial * Underwent liver transplantation or liver transplantation in schedule * Allergic to nucleoside or nucleotide analogues * Pregnancy or in breastfeeding

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

virological response rate

Timeframe: week 96

Trial details

NCT IDNCT02327689

SponsorAsian-Pacific Alliance of Liver Disease, Beijing

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

Contact for this trial

Jun Cheng, M.D.

+86 10 84322116 jun.cheng.ditan@gmail.com

View on ClinicalTrials.gov More Hepatitis B, Chronic trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.