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Safety and Antiviral Activity of Clevudine in Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials
This study has been terminated.
First Received: August 8, 2006   No Changes Posted
Sponsored by: Bukwang Pharmaceutical
Information provided by: Bukwang Pharmaceutical
ClinicalTrials.gov Identifier: NCT00362505
  Purpose

The purpose of this study is to determine safety and efficacy of clevudine 10 mg qd for 24 weeks after completion of 24-week treatment with clevudine 30 mg qd with 12 weeks follow-up period


Condition Intervention Phase
Hepatitis B
Drug: Clevudine
Phase III

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Phase III Clinical Trial to Evaluate the Safety and Antiviral Activity of Clevudine in Chronic Hepatitis B Patients Who Have Completed the L-FMAU-301 or L-FMAU-302 Trials

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Efficacy:change from baseline in HBV DNA; Safety: clinically measured adverse events, abnormality of laboratory tests and abnormality of vital signs, ECG.

Secondary Outcome Measures:
  • Efficacy:; Proportion of patients with HBV DNA below the assay Limit of Detection; Proportion of patients with HBeAg loss and/or seroconversion (HBeAg loss and HBeAb gain); Proportion of ALT normalization

Study Start Date: June 2004
Estimated Study Completion Date: March 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is between 18 and 60, inclusive
  2. Patients who have completed L-FMAU-301 or L-FMAU-302 clinical trial.
  3. Patient is HBsAg positive at week 48 in L-FMAU-301 or L-FMAU-302.
  4. Patient has bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL at week 48 in L-FMAU-301 or L-FMAU-302.
  5. Women of childbearing potential must have a negative serum (β-HCG) pregnancy test at screening.
  6. Patient is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Patients with HBV DNA < 4,700 copies/mL, ALT normalization and consecutive e seroconversion at week 40 and 48 in L-FMAU-301
  2. Patients with HBV DNA < 4,700 copies/mL and ALT normalization in L-FMAU-302
  3. Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
  4. Patients previously treated with α-interferon, lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
  5. Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  6. Patient is coinfected with HCV, HDV or HIV.
  7. Patient with clinical evidence of liver mass or hepatocellular carcinoma and α-Fetoprotein > 50 ng/mL
  8. Patient is pregnant or breast-feeding.
  9. Patient is unwilling to use an “effective” method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
  10. Patient has a clinically relevant history of abuse of alcohol or drugs.
  11. Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, biliary diseases excluding asymptomic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor except for liver mass, excluded if judged by an investigator that the continuation of study would be interfered by the tumor.
  12. 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]

13.Patient whom investigator consider is not suitable in this study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362505

  Show 32 Study Locations
Sponsors and Collaborators
Bukwang Pharmaceutical
Investigators
Principal Investigator: Hyo-Suk Lee, MD. PhD Seoul National University Hospital
  More Information

No publications provided

Study ID Numbers: L-FMAU-303
Study First Received: August 8, 2006
Last Updated: August 8, 2006
ClinicalTrials.gov Identifier: NCT00362505     History of Changes
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Anti-Infective Agents
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis B, Chronic
2'-fluoro-5-methylarabinosyluracil
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Antiviral Agents

Additional relevant MeSH terms:
Anti-Infective Agents
Liver Diseases
Hepatitis, Viral, Human
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
2'-fluoro-5-methylarabinosyluracil
Hepatitis B
DNA Virus Infections

ClinicalTrials.gov processed this record on September 02, 2009