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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01264354
Other study ID # CLV-412
Secondary ID
Status Completed
Phase Phase 4
First received December 19, 2010
Last updated December 16, 2014
Start date March 2010
Est. completion date February 2013

Study information

Verified date December 2014
Source Bukwang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2013
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient is 18 years and older.

- Patient is documented to be HBsAg positive for > 6 months.

- Patient is HBV DNA positive with DNA levels = 1×10^5 copies/mL within 30days of baseline.

- Patient has ALT levels = 1×ULN

- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

- Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.

- Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.

- Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.

- Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin=3.5g/dL)

- Patient is coinfected with HCV, HDV or HIV.

- Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.

- Patient with clinical evidence of hepatocellular carcinoma

- Patient with previous liver transplantation

- Patient is pregnant or breast-feeding.

- Patient has a clinically relevant history of abuse of alcohol or drugs.

- Patient has a significant immunocompromised, gastrointestinal, renal,

- hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.

- Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Clevudine 30mg
Clevudine 30mg
Clevudine 20mg+Adefovir dipivoxil 10mg
Clevudine 20mg+ Adefovir 10mg
Clevudine 20mg
Clevudine 20mg

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with HBV DNA levels < 300 copies/mL 24 week No
Secondary The change of HBV DNA form the baseline (log copies/mL) 24week, 48week, 96week No
Secondary Proportion of patients with HBV DNA < 300 copies/mL 48week, 96week No
Secondary Proportion of patients with ALT normalization 24week, 48week, 96week No
Secondary Proportion of patients with HBeAg loss and/or seroconversion 96 Week No
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