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NCT05382351
Antiviral Therapy for Patients With Chronic Hepatitis B Infection
Phase 2 trial testing Entecavir in Chronic Hepatitis B Virus Infection in 238 participants. Status unknown.
30 April 2024
Quick facts
| Lead sponsor | Sun Yat-sen University |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 238 |
| Start date | 10 May 2022 |
| Primary completion | 30 April 2024 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Entecavir (ENTECAVIR) — full drug profile →
- Entecavir combined with Tenofovir Amibufenamide — full drug profile →
Conditions studied
- Chronic Hepatitis B Virus Infection — all drugs for Chronic Hepatitis B Virus Infection →
Sponsor
Sun Yat-sen University
Who can join
Adults 18 to 65, any sex, with Chronic Hepatitis B Virus Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study aims to demonstrate that antiviral therapy for patients with immune tolerance of CHB. On the basis of the original antiviral therapy of entecavir, further clarify the safety and effectiveness of entecavir combined with tenofovir amibufenamide.The investigators plan to enroll about 328 hepatitis B patients,. who are in the stage of immune tolerance. These participants will be devided into two groups randomly .Group A will receive the treatment of entecavir. Group B will be treated with entecavir and tenofovir amibufenamide. The participants in both groups will be followed up for 96 weeks. The primary endpoint is to compare the inhibition rate of HBV-DNA between two groups. The secondary endpoint includes: (1) Comparing the decrease of HBV DNA at 48 weeks between the two groups. (2) Comparing the HBeAg seroconversion rates at 48 weeks and 96 weeks between the two groups. (3) The changes of HBsAg at 48 weeks and 96 weeks between the two groups. (4) Comparing adverse side effects between the two groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05382351
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Other trials of Entecavir
Trials testing the same drug.
- NCT07345611 — Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B · Phase 4 · not yet recruiting
- NCT07345624 — Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B · Phase 4 · not yet recruiting
- NCT07295873 — Drug-Drug Interaction Study Between Hydronidone and Entecavir, Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide, and · Phase 1 · not yet recruiting
- NCT06966232 — Prophylactic or Preemptive Entecavir in Patients With Gastrointestinal Cancer Who Are Inactive Hepatitis B Carriers · Phase 3 · recruiting
- NCT05423834 — Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir · active not recruiting
Other recruiting trials for Chronic Hepatitis B Virus Infection
Currently open trials in the same condition.
- NCT07389044 — A Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B · Phase 1 · recruiting
- NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
Other Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat · Phase 2 · not yet recruiting
- NCT07371897 — Toripalimab ± Chemo as Neoadjuvant Therapy in LA-HNSCC: A Phase III Trial · Phase 3 · not yet recruiting
- NCT07489703 — SHR-A1811 + AK112 in HER2-Altered Advanced/Metastatic NSCLC · Phase 2 · not yet recruiting
- NCT07528209 — Neoadjuvant CAPOX With or Without Pucotenlimab Plus Selective Radiotherapy for Locally Advanced Rectal Cancer · Phase 3 · recruiting
- NCT07522281 — Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05382351 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Yat-sen University
- Last refreshed: 19 May 2022
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