A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Bukwang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01264133
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012

December 19, 2010
July 24, 2012
September 2009
June 2013   (final data collection date for primary outcome measure)
Proportion of patients with HBV DNA levels < 60 IU/mL [ Time Frame: 48 week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01264133 on ClinicalTrials.gov Archive Site
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Not Provided
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A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B
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

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: Clevudine, Adefovir
Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg 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 2014
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.
  3. Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
  4. Patient has ALT levels >=80 IU/L
  5. Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis <= 6)
  6. 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, peg-interferon or other immunomodulatory within the previous 6 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 has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  6. Patient with clinical evidence of decompensated liver disease or hepatocellular carcinoma
  7. Patient with previous liver transplantation
  8. Patient is pregnant or breast-feeding.
  9. Patient has a clinically relevant history of abuse of alcohol or drugs.
  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]
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01264133
CLV-411, CLV-411
No
Byungchul Yoo, Samsung Medical Center
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