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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01264354
• Other study ID #: CLV-412
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2010
• Last updated: December 16, 2014
• Start date: March 2010
• Est. completion date: February 2013

Study information

• Verified date: December 2014
• Source: Bukwang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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]

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Clevudine 30mg
Clevudine 30mg
• Clevudine 20mg+Adefovir dipivoxil 10mg
Clevudine 20mg+ Adefovir 10mg
• Clevudine 20mg
Clevudine 20mg

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Bukwang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with HBV DNA levels < 300 copies/mL		24 week	No
Secondary	The change of HBV DNA form the baseline	(log copies/mL)	24week, 48week, 96week	No
Secondary	Proportion of patients with HBV DNA < 300 copies/mL		48week, 96week	No
Secondary	Proportion of patients with ALT normalization		24week, 48week, 96week	No
Secondary	Proportion of patients with HBeAg loss and/or seroconversion		96 Week	No