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

NCT01264133 | Terminated Phase 4

• 1 other identifier: CLV-411
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with HBV DNA levels < 60 IU/mL

  48 week

Interventions

Clevudine, Adefovir DRUG

Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg qd

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is 18 years and older.
• Patient is documented to be HBsAg positive for \> 6 months.
• Patient is HBV DNA positive with DNA levels ≥ 2,000 IU/mL within 30 days of baseline.
• Patient has ALT levels \>=80 IU/L
• Patient with compensated liver disease (Patient with chronic B Hepatitis or liver cirrhosis \<= 6)
• Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

You may not qualify if:

• 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 or any other investigational nucleoside for HBV infection.
• Patient is coinfected with HCV, HDV or HIV.
• Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
• Patient with clinical evidence of decompensated liver disease or 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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

clevudine; adefovir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2010
• First Posted: December 21, 2010
• Study Start: September 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

KR (1)