Clinical trial NCT01263002: A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCC
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 Associated Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Associated Hepatocellular Carcinoma
Lead sponsor: Bukwang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-12-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open study to evaluate the Efficacy, Safety of Clevudine monotherapy or Adefovir and Clevudine combination in Proportion to Roadmap Concept in patients with chronic hepatitis B Associated Hepatocellular Carcinoma


Eligibility criteria: Inclusion Criteria

1. Patient with chronic HBV DNA and/or with symptoms of liver cirrhosis
2. Patient with Hepatocellular carcinoma evidenced by sonography, CT scan, or MRI scan)
3. Patient is 18 years and older.
4. Patient is documented to be HBsAg positive for \> 6 months.

   * Laboratory report proving HBsAg positive or HBeAg positive for at least six months
   * IgM anti-HBc negative, IgG anti-HBc positive at screening
5. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
6. Patient has ALT or AST levels \>=40 IU/L
7. Cell carcinoma/hepatocellular carcinoma patient who is anticipated to live at least 1 year.
8. Patient who is fully active, able to carry on all pre-disease performance without restriction or restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
9. Patient who is classified as NYHA functional classification grade 1-2. (NYHA;New York Heart Association)
10. 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 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, tenofovir or any other investigational nucleoside for HBV infection.
4. Patient is coinfected with HCV, HDV or HIV.
5. Patient with metastatic malignancy.
6. Patient with previous liver transplantation
7. Patient is pregnant or breast-feeding.
8. Patient has a clinically relevant history of abuse of alcohol or drugs.
9. Patient use oriental medicine within the previous 2 weeks.
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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Primary outcomes:
measure: Proportion of patients with HBV DNA levels < 60 IU/mL
timeFrame: 48 week
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: