Clinical trial for Chronic Hepatitis B
Official title A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatitis B
ClinicalTrials.gov ID: NCT07307586
What this study is testing
What is AZVUDINE?
This is an investigational medicine being studied as a potential treatment for chronic hepatitis B. It is designed to fight the virus and help activate the body's immune system.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- Who it's for
- People living with chronic Hepatitis B.
- What's involved
- Taking Adefovir tablets and getting regular blood tests to check virus levels, liver health, and immune system activity.
- Time commitment
- The study involves long-term monitoring to see if the treatment works over time.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meet the diagnostic criteria for viral hepatitis as outlined in the Chinese Medical Association's Hepatology Branch Guidelines for the Prevention and...
- HBV DNA load \> 20,000 copies/mL and HBsAg \< 1,500 IU/mL;
- Serum alanine aminotransferase (ALT) \> 2 times the upper limit of normal;
- No prior antiviral therapy prior to hospital admission.
You likely can't join if
- Individuals co-infected with other hepatotropic viruses, such as hepatitis A, C, D, or E viruses, or HIV;
- Patients with concomitant liver metabolic disorders, cirrhosis, autoimmune-related diseases, or other chronic conditions;
- Pregnant or breastfeeding women, or those planning pregnancy within one year;
- Patients who have received or are currently undergoing antineoplastic therapy;
- History of alcohol or substance abuse;
- Patients currently taking therapeutic medications or health supplements;
See the full eligibility criteria
- Meet the diagnostic criteria for viral hepatitis as outlined in the Chinese Medical Association's Hepatology Branch Guidelines for the Prevention and Treatment of Chronic Hepatitis B, with patients demonstrating...
- HBV DNA load \> 20,000 copies/mL and HBsAg \< 1,500 IU/mL;
- Serum alanine aminotransferase (ALT) \> 2 times the upper limit of normal;
- No prior antiviral therapy prior to hospital admission.
- Individuals co-infected with other hepatotropic viruses, such as hepatitis A, C, D, or E viruses, or HIV;
- Patients with concomitant liver metabolic disorders, cirrhosis, autoimmune-related diseases, or other chronic conditions;
- Pregnant or breastfeeding women, or those planning pregnancy within one year;
- Patients who have received or are currently undergoing antineoplastic therapy;
- History of alcohol or substance abuse;
- Patients currently taking therapeutic medications or health supplements;
- Patients who participated in other clinical trials within 30 days prior to enrolment;
- Patients with allergic constitutions or hypersensitivity to any drug or component used in this study;
- Patients with gastrointestinal disorders that may impair drug absorption.
The study team makes the final eligibility decision.
Where it is enrolling
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Zhengzhou, Henan, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.