NCT04202536UnknownPhase 4
A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretreated With TDF
IlDong Pharmaceutical Co Ltd1 site in 1 country152 target enrollmentStarted: May 29, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- IlDong Pharmaceutical Co Ltd
- Enrollment
- 152
- Locations
- 1
- Primary Endpoint
- The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week
Study Overview
Brief Summary
A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •20 years of age and older, Male or female patients
- •Patients who show positive HBsAg or has a history of chronic hepatitis B for the last six months or more before screening
- •Patients who have been on tenofovir disoproxil fumarate (TDF) monotherapy for more than 48 weeks and are taking TDF at the time of clinical screening
- •At screening, had HBV DNA < 20 IU/mL
- •Patients who were explained about the purpose, methods and effects of the clinical trial and then, signed a written consent form
Exclusion Criteria
- •Patients who have received interferon (including Pegylation formulation) to treat chronic hepatitis for more than 12 months.
- •Patients who have taken Besifovir
- •Patients who have experienced hepatitis B virus resistance to antiviral drugs
- •Patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient
- •Patient has history of organ transplantation
- •Patients who had received the following drugs for the last two months before screening (however, short-term use (less than consecutive 14 days) of these drugs and low-dose aspirin (100 mg, maximally, 300 mg/day) are allowed.)
- •Nephrotoxic drugs (e.g. Aminoglycosides, Amphotericin B, NSAIDs)
- •Hepatotoxic drugs (e.g. Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone)
- •Anticoagulant (e.g. Warfarin)
- •Patients who are suspected by an investigator to have the level of immunity decreased among patients who had been administered with immunosuppressants within 12 months before screening
- •Patients who had been administered with long-term general corticosteroids (more than consecutive 14 days) at a high dose (more than prednisolone 20 mg daily*) within three months before screening (In case of local corticosteroids, an investigator decides it.)
- •It is equal to cortisone 125 mg, hydrocortisone 100 mg, prednisone 20 mg, methylprednisolone 16 mg, triamcinolone 16 mg, dexamethasone 3 mg, betamethasone 2.4 mg
- •Patients who have a past medical history of clinical alcohol or drug abuse within a year before screening or now are abusers
- •Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus
- •Patients who have other hepatic diseases (hematochromatosis, Wilson's disease, alcoholic liver diseases, nonalcoholic steatohepatitis, α1-antitrypsin deficiency) except hepatitis B
- •Patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems
- •Patients who showed Glomerular Filtration Rate (GFR) less than 50 mL/min by calculating Modification of Diet in Renal Disease (MDRD: 1.86 x phosphocreatine -1.154 x age -0.203 (x 0.742 for women)) during screening
- •Patients who showed alpha-fetoprotein(AFP) more than 50 ng/mL during screening and are estimated to have hepatocellular carcinoma (HCC) through liver/abdomen CT scans
- •At least one of the following laboratory values during screening
- •Hemoglobin < 9.0 g/dL
- •Absolute neutrophil count (ANC) < 1.0 x 10^9 /L (1000 /mm^3)
- •Platelet count < 75 x 10^9 /L (100 x 10^3 /mm3)
- •Serum creatinine > 1.5 mg/dL
- •Serum amylase > 2 x upper limit normal (ULN) and Lipase > 2 x ULN
- •Total Bilirubin > 2 x ULN
- •Serum albumin < 28 g/L (2.8 g/dL)
- •Pregnant women, lactating women, or patients who planned pregnancy during a trial period
- •Patients who participate in other clinical trials or is supposed to do so during the study period
- •Patients who have hypersensitivity to the clinical trial drug in this clinical trial
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients who are considered to be unacceptable in this study under the opinion of the investigator
Arms & Interventions
TDF switch to Besifovir Dipivoxil Maleate
Experimental
Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Besifovir Dipivoxil Maleate 183mg daily
Intervention: Besifovir Dipivoxil Maleate (Drug)
Maintaining on TDF
Active Comparator
Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily
Intervention: Tenofovir disoproxil fumarate(TDF) (Drug)
Outcomes
Primary Outcomes
The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week
Time Frame: at the 48th week
Secondary Outcomes
- The rate of subjects who maintained HBV DNA less than 20 IU/mL at the 24th week(at the 24th week)
Investigators
Study Sites (1)
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