NCT04619082Active, not recruitingPhase 4
TAF to Prevent HBV Reactivation in Cancer Patients
The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy
Source: ClinicalTrials.gov · Last updated 12 Nov 2024
Brief summary (registry, in English)
Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Therefore, we conduct a prospective single arm study to evaluate the efficacy and safety of TAF as a prophylactic antiviral agent for HBsAg-positive cancer patients receiving chemotherapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 2 Nov 2020
- Start date
- 1 Jul 2021
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Chiayi Christian Hospital
- Diseases
- Hepatitis B
- NCT number
- NCT04619082
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 102
- From 1 Jul 2021 to the primary completion date, 31 Dec 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients had exposure to any NUC or interferon within 6 months before chemotherapy
Other illness
- Patients were co-infected with HCV or HIV
- Allergy history to any tenofovir-based medication
Lab values
- Patients had eGFR lower than 15 ml/min/1.73m2 and didn't receive dialysis
Other
- Patients with poor performance status (Zubrod-ECOG ≥ 2 or Karnofsky score ≤ 70)
- Patients with cirrhosis
- Pregnant woman
- Unable to sign inform consent
Who the study is looking for
- Adult patients (age ≥20) with positive HBsAg who are prepared to receive systemic chemotherapy
- The presence of HBs antigen should be confirmed within recent two years
- The patients who could receive systemic chemotherapy in 4 weeks
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ditmanson Medical Foundation Chiayi Christian Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| St. Martin De Porress Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| Dalin Tzu Chi General Hospital Coordinator of this site? Confirm its status | Chiayi City | Taiwan | Unknown status |
| National Taiwan University Hospital Yun-Lin Branch Coordinator of this site? Confirm its status | Douliu | Taiwan | Unknown status |
| Chi Mei Medical Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.