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
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Clevudine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy and the Change of sAg Levels in Chronic Hepatitis B Patients Receiving Clevudine Treatment Over the Long Period

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA below the assay limit of detection [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: November 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Clevudine
    clevudine 30 mg qd
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01264094

Locations
Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

No publications provided

Responsible Party: Kwan Sik Lee/Gangnam Severance Hospital, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT01264094     History of Changes
Other Study ID Numbers: CLV-408
Study First Received: December 19, 2010
Last Updated: July 24, 2012
Health Authority: Korea:Korea Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Clevudine
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014