Trials / Unknown
UnknownNCT03597633
Tenofovir Combination or Mono-therapy for MDR CHB
Tenofovir-based Combination Therapy or Monotherapy for Multi-drug Resistant Chronic Hepatitis B; Real World Data From Multicenter Cohort Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 236 (actual)
- Sponsor
- Korea University · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- —
Summary
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.
Detailed description
Inclusion criteria were CHB patients with resistance to more than two classes of nucleos(t)ide analogues (NA) and hepatitis B virus (HBV) DNA level ≥200 IU/mL. Patients will receive either TDF-base combination therapy or TDF monotherapy. The primary end point is virologic response (VR) defined by an undetectable HBV DNA (\<20 IU/mL) at month 36.
Conditions
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2018-12-31
- Completion
- 2019-12-31
- First posted
- 2018-07-24
- Last updated
- 2018-07-24
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03597633. Inclusion in this directory is not an endorsement.