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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01264133
Other study ID # CLV-411
Secondary ID CLV-411
Status Terminated
Phase Phase 4
First received December 19, 2010
Last updated December 16, 2014
Start date September 2009
Est. completion date December 2014

Study information

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

Clinical Trial Summary

An open study to Evaluate the Efficacy, Safety and Sustained effect of Clevudine monotherapy or Adefovir and Clevudine combination in proportion to Roadmap concept in Patients with chronic hepatitis B.


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date December 2014
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Patient is 18 years and older.

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

3. Patient is HBV DNA positive with DNA levels = 2,000 IU/mL within 30 days of baseline.

4. Patient has ALT levels >=80 IU/L

5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis <= 6)

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

Exclusion Criteria:

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

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

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

4. Patient is coinfected with HCV, HDV or HIV.

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

6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma

7. Patient with previous liver transplantation

8. Patient is pregnant or breast-feeding.

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

10. 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.

11. 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

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


Intervention

Drug:
Clevudine, Adefovir
Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg qd

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 < 60 IU/mL 48 week No
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