A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Bukwang Pharmaceutical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01264094
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012

December 19, 2010
July 24, 2012
November 2009
June 2013   (final data collection date for primary outcome measure)
Proportion of patients with HBV DNA below the assay limit of detection [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01264094 on ClinicalTrials.gov Archive Site
  • The change of HBV DNA from the baseline. [ Designated as safety issue: No ]
  • Proportion of patients with HBeAg loss and/or seroconversion. [ Designated as safety issue: No ]
  • Biochemical improvement (e.g. ALT normalization). [ Designated as safety issue: No ]
  • Proportion of sAg loss [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period
A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

The purpose of this study is to evaluate the efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period.

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: Clevudine
clevudine 30 mg qd
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patient is 18 years and older.
  2. Patient is documented to be HBsAg positive for > 6 months and HBV DNA positive.
  3. Patient is HBeAg positive or negative.
  4. Patient has ALT levels ≥ 80 IU/L
  5. 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 within the previous 3 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 is pregnant or breast-feeding.
  6. Patient has a clinically relevant history of abuse of alcohol or drugs.
  7. 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.
  8. 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]
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01264094
CLV-408
No
Kwan Sik Lee/Gangnam Severance Hospital, Gangnam Severance Hospital
Bukwang Pharmaceutical
Not Provided
Not Provided
Bukwang Pharmaceutical
July 2012

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