An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

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:
NCT01264354
First received: December 19, 2010
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Clevudine 30mg
Drug: Clevudine 20mg+Adefovir dipivoxil 10mg
Drug: Clevudine 20mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Bukwang Pharmaceutical:

Primary Outcome Measures:
  • Proportion of patients with HBV DNA levels < 300 copies/mL [ Time Frame: 24 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change of HBV DNA form the baseline [ Time Frame: 24week, 48week, 96week ] [ Designated as safety issue: No ]
    (log copies/mL)

  • Proportion of patients with HBV DNA < 300 copies/mL [ Time Frame: 48week, 96week ] [ Designated as safety issue: No ]
  • Proportion of patients with ALT normalization [ Time Frame: 24week, 48week, 96week ] [ Designated as safety issue: No ]
  • Proportion of patients with HBeAg loss and/or seroconversion [ Time Frame: 96 Week ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Clevudine 30mg
Drug: Clevudine 30mg
Clevudine 30mg
Other Name: Levovir 30mg
Experimental: 2
Clevudine 20mg+Adefovir dipivoxil 10mg
Drug: Clevudine 20mg+Adefovir dipivoxil 10mg
Clevudine 20mg+ Adefovir 10mg
Other Name: Levovir 20mg+Adefovir 10mg
Experimental: 3
Clevudine 20mg
Drug: Clevudine 20mg
Clevudine 20mg
Other Name: Levovir 20mg

  Eligibility

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

Inclusion Criteria:

  • Patient is 18 years and older.
  • Patient is documented to be HBsAg positive for > 6 months.
  • Patient is HBV DNA positive with DNA levels ≥ 1×10^5 copies/mL within 30days of baseline.
  • Patient has ALT levels ≥ 1×ULN
  • Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  • Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
  • Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
  • Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
  • Patient with clinical evidence of decompensated liver disease (Total bilirubin < 2.0mg/dL, Prothrombin time < 1.7(INR), Serum albumin≥3.5g/dL)
  • Patient is coinfected with HCV, HDV or HIV.
  • Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
  • Patient with clinical evidence of hepatocellular carcinoma
  • Patient with previous liver transplantation
  • Patient is pregnant or breast-feeding.
  • Patient has a clinically relevant history of abuse of alcohol or drugs.
  • 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.
  • 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: NCT01264354

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Bukwang Pharmaceutical
  More Information

No publications provided

Responsible Party: Byung Chul Yoo/Samsung Medical Center, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01264354     History of Changes
Other Study ID Numbers: CLV-412
Study First Received: December 19, 2010
Last Updated: July 24, 2012
Health Authority: 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
Adefovir
Adefovir dipivoxil
Clevudine
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014