Chronic Hepatitis b With Multidrug Resistance Clinical Trial
Official title:
Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study
| Verified date | July 2018 |
| Source | Korea University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
Treatment of multidrug resistant (MDR) chronic hepatitis B (CHB) is still a challenging issue. Hence, the investigators will perform a multicenter prospective cohort study for the evaluation of tenofovir disoproxil fumarate (TDF)-based therapy for MDR CHB at real life settings.
| Status | Active, not recruiting |
| Enrollment | 236 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - CHB patients with: 1. documented HBsAg positivity at least 6 months before enrollment 2. age >18 years old, 3. confirmed genotypic resistance to more than two classes of NAs 4. HBV DNA level = 200 IU/mL 5. compensated liver diseases (defined by Child-Pugh-Turcotte score <7; prothrombin time <3 seconds above upper limit of normal or international normalized ratio <1.5; serum albumin >3 g/dL; total bilirubin <2.5 mg/dL; no history of esophago-gastric variceal bleeding, ascites, over hepatic encephalopathy) 6. willingness to give an informed consent. Exclusion Criteria: 1. laboratory abnormalities of low serum phosphorous level <2.0 mEq/dL, elevated serum creatinine >1.5 mg/dL, decreased creatinine clearance rate <50 mL/min, absolute neutrophil count <1000 cell/mL, or low hemoglobin level <10 g/dL (if female, <9 g/dL) 2. no definite evidence of genotypic resistance 3. positive antibody test for hepatitis C virus, hepatitis D virus, or human immunodeficiency virus 4. HCC 5. a proof of pregnant or lactating women 6. evidence of active alcohol consumption (140 g per a week for men and 70 g per a week for women) 7. any untreated malignancy. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Korea University Ansan Hospital | Ansan | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Korea University | CHA University, Chonbuk National University, Hallym University, Inje University, Soon Chun Hyang University, The Catholic University of Korea, Yonsei University |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Adverse event | Any untoward event related or not related to the study medication | 36 months, 60 months | |
| Primary | Virologic Response | undetectable HBV DNA (<20 IU/mL) | 36 months | |
| Secondary | Virologic Response | undetectable HBV DNA (<20 IU/mL) | 60 months | |
| Secondary | mean HBV DNA | mean HBV DNA levels | 36 months, 60 months | |
| Secondary | ALT normalization | rates of ALT normalization | 36 months, 60 months | |
| Secondary | Hepatitis B e antigen (HBeAg) seroconversion | rates of Hepatitis B e antigen (HBeAg) seroconversion | 36 months, 60 months | |
| Secondary | virologic breakthrough | Incidence of virologic breakthrough defined by increase of HBV DNA more than 1 log IU/mL from nar dir. | 36 months, 60 months | |
| Secondary | Genotypic resistance | Detection of previously known mutations to be resistant to the drugs being administered. | 36 months, 60 months |