Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate

Last updated: December 16, 2019
Sponsor: IlDong Pharmaceutical Co Ltd
Overall Status: Active - Recruiting

Phase

4

Condition

Hepatitis

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT04202536
ID-BVCL-403
  • Ages > 20
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 20 years of age and older, Male or female patients

  2. Patients who show positive HBsAg or has a history of chronic hepatitis B for the lastsix months or more before screening

  3. Patients who have been on tenofovir disoproxil fumarate (TDF) monotherapy for morethan 48 weeks and are taking TDF at the time of clinical screening

  4. At screening, had HBV DNA < 20 IU/mL

  5. Patients who were explained about the purpose, methods and effects of the clinicaltrial and then, signed a written consent form

Exclusion

Exclusion Criteria:

  1. Patients who have received interferon (including Pegylation formulation) to treatchronic hepatitis for more than 12 months.

  2. Patients who have taken Besifovir

  3. Patients who have experienced hepatitis B virus resistance to antiviral drugs

  4. Patient diagnosed with a malignant tumor within 5 years before screening or relapsedpatient

  5. Patient has history of organ transplantation

  6. 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-doseaspirin (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)

  1. Patients who are suspected by an investigator to have the level of immunity decreasedamong patients who had been administered with immunosuppressants within 12 monthsbefore screening

  2. Patients who had been administered with long-term general corticosteroids (more thanconsecutive 14 days) at a high dose (more than prednisolone 20 mg daily*) within threemonths before screening (In case of local corticosteroids, an investigator decidesit.)

  • 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
  1. Patients who have a past medical history of clinical alcohol or drug abuse within ayear before screening or now are abusers

  2. Patients with hepatitis C virus, hepatitis D virus or human immunodeficiency virus

  3. Patients who have other hepatic diseases (hematochromatosis, Wilson's disease,alcoholic liver diseases, nonalcoholic steatohepatitis, α1-antitrypsin deficiency)except hepatitis B

  4. Patient concerned about the decline in daily activity or not able to understand theobjectives and methods due to the psychiatric problems

  5. Patients who showed Glomerular Filtration Rate (GFR) less than 50 mL/min bycalculating Modification of Diet in Renal Disease (MDRD: 1.86 x phosphocreatine -1.154x age -0.203 (x 0.742 for women)) during screening

  6. Patients who showed alpha-fetoprotein(AFP) more than 50 ng/mL during screening and areestimated to have hepatocellular carcinoma (HCC) through liver/abdomen CT scans

  7. 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)

  1. Pregnant women, lactating women, or patients who planned pregnancy during a trialperiod

  2. Patients who participate in other clinical trials or is supposed to do so during thestudy period

  3. Patients who have hypersensitivity to the clinical trial drug in this clinical trial

  4. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiencyor glucose-galactose malabsorption

  5. Patients who are considered to be unacceptable in this study under the opinion of theinvestigator

Study Design

Total Participants: 152
Study Start date:
May 29, 2019
Estimated Completion Date:
October 31, 2021

Connect with a study center

  • Korea University Medical Center

    Ansan, Kyounggi-do
    Korea, Republic of

    Active - Recruiting

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