A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

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

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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