The Difficult-to-treat Chronic Hepatitis B Clinical Trial
| NCT number | NCT02019966 |
| Other study ID # | 4-2013-0704 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 12, 2014 |
| Est. completion date | August 4, 2017 |
| Verified date | July 2018 |
| Source | Yonsei University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Antiviral resistance remains an important issue for long-term NA therapy. For lamivudine (LAM), the rtM204V/I and rtL180M mutations occur in more than 70% after 5 years of therapy. In Korea, primarily owing to limited subsidization policy in the health insurance system, many patients with LMV-resistance had been treated with either rescue ADV or ETV 1.0 mg monotherapy, ultimately leading to the higher prevalence of MDR strain. For those patients, rescue therapies of combining ADV with either ETV or LAM had been tried, but frequently with suboptimal responses. Rescue TDF monotherapy or TDF-based combination therapy are available in Korea for patients who had "difficult-to-treat" antiviral resistance owing to prior treatment failures. However, which is the better has not been evaluated yet. A long-term efficacy and safety of TDF-based rescue therapies in real practice for those patients should be necessary to revise the Korean guideline for the treatment of chronic hepatitis B in near future.
| Status | Completed |
| Enrollment | 1020 |
| Est. completion date | August 4, 2017 |
| Est. primary completion date | August 4, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - more than 20 years old adults - chronic hepatitis B - the patients treated by tenofovir alone or tenofovir based combination therapy because of the previous treatment failure - the patients who agree and singed on the consent form Exclusion Criteria: - co-infected patients with HCV, HDV or HIV - pregnancy or breast feeding woman or female patients who are planning to be pregnant - past history with hepatocellular carcinoma - combined with other liver disease including wilson, alcoholic, NASH, alpha-1 antitrypsin deficiency liver disease. - patients with hypersensitivity for drugs - patients who were enrolled in other clinical study within 60 days - patients who were eligible for the clinical study according to the investor |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Department of Internal Medicine, Yonsei University College of Medicine | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Yonsei University |
Korea, Republic of,
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van Bömmel F, de Man RA, Wedemeyer H, Deterding K, Petersen J, Buggisch P, Erhardt A, Hüppe D, Stein K, Trojan J, Sarrazin C, Böcher WO, Spengler U, Wasmuth HE, Reinders JG, Möller B, Rhode P, Feucht HH, Wiedenmann B, Berg T. Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology. 2010 Jan;51(1):73-80. doi: 10.1002/hep.23246. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The proportion of subjects who achieve a sustained HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) at each year during the on treatment follow-up period. | The viral response which is defined as serum HBV DNA < 60 IU/mL | 1, 2, and 3 years after the treatment initiation. |