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New treatment option for Non-cirrhotic, Chronic Hepatitis B
Official title TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load.
ClinicalTrials.gov ID: NCT05195450
What this study is testing
What is Tenofovir alafenamide fumarate?
Tenofovir alafenamide fumarate is an investigational medicine, given as a monthly, being studied as a potential treatment for non-cirrhotic, chronic hepatitis b.
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.
- What it's testing
- The main goal of therapy for patients with chronic HBV infection with no significant liver disease is to improve survival and quality of life by preventing disease progression, development of liver cirrhosis and consequently HCC development. The likelihood of achieving these goals depends on the timing of therapy during the natural course of the infection but also on the stage of the disease and the patients' age when treatment is started.
- Which group you join is decided by chance.
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 70
You may be able to join if
- \- HBsAg+
- Persistent normal ALT 3-6m apart (\<30 IU/ml in male and \<20 IU/ml in female)
- HBV DNA \< 2000 IU/ml
- LSM \<8 Kpa
You likely can't join if
- Prior NUC/IFN exposure
- Renal dysfunction (Serum Creatinine \>1.5 mg/dl)
- Known liver cirrhosis/ esophageal varices
- Any clinical decompensation (CD)
- Pre-existing hepatocellular carcinoma
- Pregnancy
See the full eligibility criteria
- \- HBsAg+
- Persistent normal ALT 3-6m apart (\<30 IU/ml in male and \<20 IU/ml in female)
- HBV DNA \< 2000 IU/ml
- LSM \<8 Kpa
- Prior NUC/IFN exposure
- Renal dysfunction (Serum Creatinine \>1.5 mg/dl)
- Known liver cirrhosis/ esophageal varices
- Any clinical decompensation (CD)
- Pre-existing hepatocellular carcinoma
- Pregnancy
- Healthcare workers (HCW)
- Post transplant, patients with advance malignancy or on chemotherapy
- Co-infections - Hepatitis C, Hepatitis D, Human immunodeficiency virus
The study team makes the final eligibility decision.
Where it's taking place
- New Delhi, National Capital Territory of Delhi, India
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Delhi, National Capital Territory of Delhi, India. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.