NCT05195450 TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Normal ALT and Low Viral Load.
| NCT ID | NCT05195450 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Condition | Non-cirrhotic, Chronic Hepatitis B |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-02-23 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-02-23 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. The inhibition of viral replication and normalization of ALT by antiviral treatment has been shown to achieve the elimination of chronic HBV-induced necroinflammatory activity and progressive fibrotic liver progression in the vast majority of patients, in turn reducing the risk of HCC. Even in HBeAg positive patients, treatment-induced HBeAg loss and seroconversion to antiHBe characterizes the induction of a partial immune control often leading to a low replicative phase of the chronic HBV infection and good outcomes. Treatment in chronic HBV infection is indicated in - presence of advanced fibrosis/cirrhosis (LSM \>11 KPA) or patients with significant fibrosis (LSM \>8 or APRI \>1.5 or \>F2 on liver biopsy) with high viral load (\>2000 IU/ml) or significantly elevated ALT (x2 ULN). Presence of any of these factors is known to increase the risk of development of cirrhosis and hepatocellular carcinoma. TAF in non-cirrhotic patients (LSM \<8 KPA) with normal ALT and low viral load (HBV DNA \<2000 IU/ml) (currently treatment ineligible) as compared to delayed initiation (on demand) might reduce HCC risk, progression of liver fibrosis and reduction in HBsAg levels. As TAF is known to have favorable effects on the overall long-term outcome, the main clinical challenge is to identify the patients at risk of HCC and cirrhosis who warrant early antiviral therapy.
Eligibility Criteria
Inclusion 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 Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05195450 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Non-cirrhotic, Chronic Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05195450 currently recruiting?
Yes, NCT05195450 is actively recruiting participants. Contact the research team at ankur.jindal3@gmail.com for enrollment information.
Where is the NCT05195450 trial being conducted?
This trial is being conducted at New Delhi, India.
Who is sponsoring the NCT05195450 clinical trial?
NCT05195450 is sponsored by Institute of Liver and Biliary Sciences, India. The trial plans to enroll 200 participants.