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

NCT01264354 | Completed Phase 4

• 1 other identifier: CLV-412
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with HBV DNA levels < 300 copies/mL

  24 week

Secondary Outcomes (4)

• The change of HBV DNA form the baseline

  24week, 48week, 96week

• Proportion of patients with HBV DNA < 300 copies/mL

  48week, 96week

• Proportion of patients with ALT normalization

  24week, 48week, 96week

• Proportion of patients with HBeAg loss and/or seroconversion

  96 Week

Study Arms (3)

1

EXPERIMENTAL

Clevudine 30mg

Drug: Clevudine 30mg

2

EXPERIMENTAL

Clevudine 20mg+Adefovir dipivoxil 10mg

Drug: Clevudine 20mg+Adefovir dipivoxil 10mg

3

EXPERIMENTAL

Clevudine 20mg

Drug: Clevudine 20mg

Interventions

Clevudine 30mg DRUG

Clevudine 30mg

Also known as: Levovir 30mg

1

Clevudine 20mg+Adefovir dipivoxil 10mg DRUG

Clevudine 20mg+ Adefovir 10mg

Also known as: Levovir 20mg+Adefovir 10mg

2

Clevudine 20mg DRUG

Clevudine 20mg

Also known as: Levovir 20mg

3

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 ≥ 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.

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, 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 \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]

Sponsors & Collaborators

• Bukwang Pharmaceutical: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

clevudine; adefovir dipivoxil; 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
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 19, 2010
• First Posted: December 21, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: February 1, 2013
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

KR (1)