Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial

This study has been completed.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00362674
First received: August 8, 2006
Last updated: December 21, 2010
Last verified: December 2010

August 8, 2006
December 21, 2010
June 2005
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00362674 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
An Open-label, Observation Study to Evaluate the Durability of Antiviral Activity in Chronic Hepatitis B Patients Who Showed Complete Response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 Trial

The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

the patients who completed the previous 301, 302 and 303 studies with clevudine

Hepatitis B
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  1. The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303.
  2. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine.
  3. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303
  4. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
  5. Patients with bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303.

Exclusion Criteria:

  1. Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302.
  2. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  3. Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection.
  4. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  5. Patients co-infected with HCV, HDV or HIV.
  6. Patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic GB stone during the L-FMAU-301, L-FMAU-302 or L-FMAU-303.
  7. Patients who were pregnant or breast-feeding.
  8. Patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic GB stone, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
  9. Patients who were not suitable to the study if judged by an investigator.
Both
Not Provided
Not Provided
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00362674
CLV-304
Not Provided
Hun Jun Jang, Bukwang Pharm.
Bukwang Pharmaceutical
Not Provided
Principal Investigator: Hyo-suk Lee, MD. PhD. Seoul National University Hospital
Bukwang Pharmaceutical
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP